China’s biotechnology sector has emerged as a formidable force, shaking off a four-year slump to become one of Asia’s hottest markets. The Hang Seng Biotech Index has surged by approximately 60% in 2025, a rally that has outstripped the 17% gain in China’s tech stocks, driven by the release of DeepSeek’s breakthrough artificial-intelligence model in January. This phenomenon, dubbed the “DeepSeek moment” for biotech, reflects China’s growing prowess in innovation, positioning the country as a global contender in drug development and biotechnology. The sector’s rise is underpinned by significant financial investments, strategic partnerships with global pharmaceutical giants, and a robust pipeline of innovative drugs, particularly in oncology.

The term “DeepSeek moment” draws from the success of DeepSeek’s R1 artificial-intelligence model, which propelled the Chinese AI startup to global prominence earlier this year. In biotech, this analogy captures the sector’s rapid ascent and its potential to disrupt global markets. “China biotech is no longer just an emerging story — unlike 10 years ago — it is now a disruptive force reshaping global drug innovation,” Yiqi Liu, senior investment analyst at Exome Asset Management LLC in New York told Bloomberg. This sentiment is echoed in the flurry of high-value licensing deals and initial public offerings (IPOs) that have invigorated investor confidence.

A notable example is the performance of companies like Akeso, a Chinese drug developer that has seen its shares climb 6.5 times their IPO price from five years ago, despite a temporary 11.8% drop following a second marketing IP for its lung cancer drug ivonescimab in April 2025. Ivonescimab, a bispecific antibody, has outperformed Merck’s blockbuster drug Keytruda in phase three trials, marking a significant milestone. “The development of the new antibody drug was hailed by the mainland media last month as the biotech industry’s ‘DeepSeek moment’,” reported the South China Morning Post, highlighting the drug’s potential to challenge global oncology standards. Akeso’s partnership with Summit Therapeutics in the US to advance ivonescimab’s clinical trials across 108 locations in 12 nations underscores China’s ambition to compete on the global stage.

The financial momentum is equally striking. In May 2025, eight licensing deals were reached in China’s biopharma sector, with five cross-border out-licensing agreements generating over £1 billion upfront and a potential £6.5 billion including milestones, according to posts on X. This represents a significant increase from April 2025, which saw six deals with £141 million upfront and £2.35 billion in total potential value. These figures reflect a growing appetite among global pharmaceutical companies for Chinese-developed drugs. For instance, Bristol-Myers Squibb agreed to pay Germany’s BioNTech SE up to £8.45 billion to license a cancer drug originally developed by China’s Biotheus Inc, which BioNTech had acquired for £590 million in 2023. Such deals highlight the economic allure of China’s biotech innovations.

Investor enthusiasm is further evidenced by the performance of recent IPOs. Shares of Duality Biotherapeutics Inc, a company focused on cancer treatments, more than doubled on their first day of trading in Hong Kong on 15 April 2025. Similarly, companies like 3SBio and RemeGen Co. have seen stratospheric gains, with 3SBio surging 283% and RemeGen climbing over 270% after announcing potential licensing deals with multinational firms. “Chinese biotech companies are having ‘their own DeepSeek moment’,” said Dong Chen, chief Asia strategist at Pictet Wealth Management in Hong Kong, pointing to the sector’s ability to attract significant capital and deliver promising pipelines.

The role of venture capital is pivotal in this transformation. Hong Kong-based ORI Capital is planning a £260 million fund to invest in Chinese healthcare startups, capitalising on the sector’s momentum. “Hong Kong-based venture capital firm ORI Capital plans to launch a new fund to invest in Chinese healthcare start-ups, as the domestic biotechnology industry experiences its own ‘DeepSeek moment’,” noted Simone Song, the firm’s founder, in an interview with the South China Morning Post. The fund aims to leverage artificial intelligence to enhance drug development, reflecting the integration of cutting-edge technologies in biotech innovation.

China’s biotech sector is not without challenges. The development of drugs like ivonescimab remains uncertain, with many candidates still in preclinical or early clinical stages, requiring years and hundreds of millions of dollars to reach market approval. Approximately 90% of compounds entering human trials fail, a reality that tempers optimism. Moreover, geopolitical tensions and US concerns about China’s biotech dominance add complexity. A US congressional report warned that “China is quickly ascending to biotechnology dominance,” urging Congress to invest £11 billion over five years to bolster US biotech, including £890 million through the Defence Department for applications like shelf-stable blood and advanced explosives. The report highlighted fears that China’s advances could have national security implications, potentially complicating cross-border collaborations.

Despite these hurdles, China’s biotech sector is capitalising on its domestic strengths. Companies like Innovent Biologics are accelerating clinical development, producing six to eight assets annually and maintaining a robust pipeline of clinical-stage drugs. “We are developing at a very fast speed and to demonstrate a clinical concept and derisking it,” a representative from Innovent told Bloomberg, emphasising the “China speed” in research and clinical trials. This efficiency, combined with substantial financial reserves (Akeso, for example, held 7.34 billion RMB in cash at the end of 2024) enables sustained innovation.

The global implications of China’s biotech rise are profound. The sector’s ability to produce cost-effective, innovative drugs is attracting Big Pharma, as seen in Merck & Co’s £82 million upfront deal with Hansoh Pharma to develop an obesity drug, with potential milestones up to £1.4 billion. Such partnerships signal a shift in the global pharmaceutical landscape, with China transitioning from a manufacturing hub to a centre of innovation. “The surge in China-listed biotech firms is further evidence that the mainland is becoming a centre for global innovation,” noted a Bloomberg report, underscoring the sector’s competitive edge.

The integration of artificial intelligence is another driver of this transformation. AI is being used to streamline drug discovery and optimise clinical trials, reducing costs and timelines. This technological synergy is particularly appealing to investors, as evidenced by ORI Capital’s AI-focused fund. The combination of biotech and AI is not only enhancing China’s domestic capabilities but also positioning its companies to compete with Western giants like Merck and Bristol-Myers Squibb.

The competitive landscape is also shaped by China’s regulatory environment, which has become more conducive to innovation. The approval of ivonescimab by China’s National Medical Products Administration (NMPA) in April 2025 for two indications demonstrates regulatory agility, contrasting with the longer timelines in markets like the US, where the drug remains in clinical trials. This regulatory efficiency, coupled with China’s large patient population for clinical studies, provides a strategic advantage.

As China’s biotech sector continues to mature, its global influence is undeniable. The success of companies like Akeso, Innovent, and Duality Biotherapeutics reflects a broader trend of Chinese firms moving beyond generic drug production to pioneering novel therapies. The financial backing from venture capital, coupled with strategic partnerships with global players, ensures that this momentum is likely to persist. However, the sector must navigate the complexities of global regulatory frameworks and geopolitical scrutiny to sustain its trajectory.

The “DeepSeek moment” for China’s biotech sector is more than a fleeting rally; it signals a structural shift in global innovation. With a combination of financial strength, technological integration, and strategic partnerships, China is redefining its role in the biotechnology landscape, challenging Western dominance and setting the stage for a new era of drug development.

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As the NHS embraces social prescribing and China advances the “Healthy China 2030” strategy, the panel examined innovations in preventative care, digital health, and patient-centred approaches, with perspectives from both the private sector and academia.

Elinor Greenhouse, Senior Adviser of Tech and Innovation at CBBC, led the discussion by highlighting the trend towards optimising health rather than simply treating disease. This shift is crucial as populations age and healthcare systems globally face increasing strain.

Sharon Heng, Consultant Ophthalmic Surgeon at Moorfields Private Eye Hospital, reinforced the idea that preventative healthcare encompasses a broad spectrum, forming an integral part of public health. She underscored the importance of screening in identifying potential health issues before they escalate, ensuring that individuals are more actively involved in managing their own well-being.

Gavin Xiaoming Gao, CEO of Penlon Limited, a medical device company, noted a key difference in how preventative healthcare is approached in the UK and China. He explained that while the UK has a well-established preventive care system, in China, it is still a developing concept but a hot topic of discussion. With an increasing emphasis on early intervention, China is rapidly advancing its preventative healthcare initiatives.

Sarah Nolan, Head of Global Programmes at the UK’s National Innovation Centre for Ageing (NICA), brought attention to the merging of medicine with nutrition. She highlighted how, in China, food plays a significant role in health, with specific dietary elements known for their precise medical benefits. This intersection between diet and medicine is a critical component of preventative care that is gaining traction globally.

Vladimir Tsaganov, Head of AI Products and Solutions at Alibaba Cloud International, discussed the role of artificial intelligence (AI) in transforming healthcare. He described AI applications such as population health analysis, medical image processing, and telemedicine. AI has significantly enhanced CT scan analysis and medical imaging, making diagnosis and treatment more efficient and accessible.

Heng elaborated on the role of AI in ophthalmology, explaining how it enhances the efficiency of eye scans and check-ups. While the private sector is beginning to integrate AI into healthcare services, she noted that its impact is currently more pronounced in public health systems.

Nolan emphasised the importance of involving consumers in product design, particularly in health-related services. By integrating consumer feedback from the outset, companies can reduce risk and ensure that their innovations align with real-world needs. She pointed out that older adults — those over 60 — hold the majority of global wealth, making their engagement in health innovation crucial. NICA’s sister organisation, VOICE, aids in identifying market gaps and helping businesses develop solutions that meet consumer demands. Initiatives such as the UK-China Accelerator have been instrumental in fostering collaboration and innovation in this field.

Heng provided an example of a successful initiative in China, citing diabetic retinal screening services as a model for effective preventative care. By leveraging digital healthcare solutions, medical providers in China are making substantial progress in service improvement. She highlighted how digital models of healthcare not only reduce costs but also enable providers to see more patients, improving accessibility and efficiency.

Nolan pointed to innovative solutions emerging from the UK-China Accelerator programme, such as exoskeleton technology, which has the potential to revolutionise rehabilitation and mobility assistance. These advancements exemplify the benefits of international collaboration in driving forward healthcare innovation.

Tsaganov also underscored the cost-effectiveness of cloud technology in healthcare, which facilitates seamless collaboration between China and the UK. He noted that AI’s scalability allows it to be applied to broader population health strategies, enabling healthcare advancements to reach a wider audience.

Gao discussed inward-bound investment opportunities, highlighting the complementary strengths of the UK and China. While UK companies excel in research, development, and advanced technology, China offers cost-effective labour and a robust supply chain. Each country brings unique advantages to the table, and fostering collaboration between them presents a win-win scenario.

Tsaganov spoke about the broader potential of international collaboration in healthcare. He stressed the need for a unified international platform to maximise the benefits of AI-driven medical innovation. China’s ability to scale healthcare technology efficiently could provide valuable lessons for the UK’s National Health Service (NHS), particularly in expanding access to medical care.

Heng touched on the role of education in promoting health awareness and preventative medicine. She pointed out that AI can also expose inequalities in healthcare access, as those without internet connectivity may face barriers to benefiting from digital health advancements. Addressing these disparities is an ongoing challenge that must be tackled alongside technological progress.

Looking to the future, the panel explored how AI and digital healthcare are set to evolve. Tsaganov predicted that data collection will enable highly personalised care, potentially integrating robotics to assist in patient care. Gao identified mental health as an area requiring urgent attention, particularly in developing tailored AI-driven solutions. Heng suggested that biomarkers could be leveraged to detect and treat illnesses at much earlier stages, significantly improving patient outcomes. Nolan reinforced the importance of personalisation in healthcare, particularly in response to rapidly ageing populations. She advocated for passive AI monitoring and underscored the significance of social connection and activity in promoting long-term health. She cited the growing trend of older adults engaging in gaming and leisure activities in China as an example of how technology can support well-being beyond traditional medical interventions.

The discussion concluded with a consensus on the immense potential for UK-China collaboration in digital healthcare. By leveraging each country’s strengths, fostering innovation, and prioritising preventative care, both nations can pave the way for a healthier future.

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Is China’s healthcare market open to foreign investment?

When investing in China’s healthcare market, one of the first considerations should be whether the specific sector they want to enter allows foreign investment.

Despite China’s continuous liberalisation of its healthcare industry to allow foreign participation by removing items from the Special Administrative Measures (Negative List) for Foreign Investment Access (hereafter referred to as the “FI Negative List”) and adding items to the Catalogue of Encouraged Industries for Foreign Investment (hereafter referred to as the “FI Encouraged Catalogue”), there are still certain sectors that remain off-limits or restricted to foreign investment.

Medical institutions

On 8 September 2024, the Ministry of Commerce (MOFCOM) published a circular on its official website announcing the expansion of pilot programs for opening up the medical sector. This circular permits wholly foreign-owned hospitals in selected cities. The Chinese government has emphasised that China will “further relax foreign investment access, completely removing restrictions on foreign investment in the manufacturing sector and accelerating the opening of the telecommunications, education, and healthcare service sectors”.

Following the initial announcement, on 29 November 2024, the National Health Commission (NHC), together with three other government departments, released a detailed work plan for wholly foreign-owned hospitals in nine cities: Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the entire island of Hainan.

In practice, even prior to recent adjustments to the regulations, some foreign investors had managed to break through these restrictions on foreign ownership ratio or even gain complete control over domestic medical institutions through historical investment, domestic reinvestment, VIE arrangement, or custody agreement. However, they may face obstacles when changing or renewing their operational qualifications, such as the Practicing License of Medical Institutions. Furthermore, in the case of subsequent shareholding changes, regulatory authorities may review the actual foreign shareholding ratio based on the “look-through approach” (穿透式审查, meaning tracing to the ultimate shareholder by looking through the multiple layers of shareholding structure based on the current effective law at that time), which may require foreign investors to reduce their ownership. Therefore, foreign investors should exercise caution when planning their investment structure.

Human stem cells and genetic technology

The aforementioned MOFCOM circular from September 2024 also lifted bans on foreign-invested enterprises (FIEs) engaging in cell and gene therapy (CGT) in selected free trade zones (FTZs).

Foreign investors are encouraged to invest in the manufacturing of high-throughput gene sequencing systems, according to the latest FI Encouraged Catalogue. Foreign investors are also generally not restricted from engaging in the import and export, production, sales, and research and development of genetic testing equipment.

On the other hand, in accordance with the Regulations of the People’s Republic of China on the Administration of Human Genetic Resources, foreign investors can cooperate with domestic institutions in scientific research related to stem cell and/or genetic diagnosis and treatment, provided that certain requirements are met, and regulatory approvals are obtained. They can also grant licenses to domestic institutions for the technological development and sale of genetic diagnostics and/or stem cell products owned by them.

Although there are established pathways for foreign investment in the sector, foreign investors may still encounter challenges. For instance, it can be challenging to clearly distinguish between the development of genetic testing equipment and the research and development of genetic testing technology in practice. Consequently, some activities of genetic testing equipment research and development enterprises may be classified as the application of genetic diagnosis and treatment technology, thereby prohibiting foreign investment. To avoid such complications, foreign investors are advised to communicate with relevant authorities in advance.

Traditional Chinese medicine

Foreign investors are prohibited from investing in the application of steaming, frying, moxibustion, calcination, and other processing techniques of traditional Chinese medicine (TCM) decoction pieces, as well as the production of confidential prescription products of proprietary Chinese medicines. However, such restrictions do not exist in China’s 21 free trade zones.

Beyond these three sectors – medical institutions, human stem cell and genetic diagnosis and treatment technology, and TCM – other healthcare sectors are mostly open to foreign investment in China.

In fact, foreign investment is actively encouraged in many healthcare areas, such as the manufacturing of new compound drugs or drugs with active ingredients, researching and developing (R&D) and manufacturing of cell therapy drugs (excluding areas where foreign investment is prohibited), manufacturing of dental implant systems for implant repair in patients with bone loss, postpartum maternal and child services in maternity centres, and rehabilitation institutes for autistic children, to name a few. Foreign investors with expertise and a strong presence in a particular area should confirm whether their business falls within these encouraged sectors to benefit from corresponding investment facilitations and receive preferential land and tax incentives.

Approval and licensing

The healthcare sector has always been subject to stringent regulations as the quality of medical services and healthcare products directly impact the safety and wellbeing of individuals. Recent efforts have been made to simplify and streamline administrative procedures in the healthcare industry, as part of medical reforms aimed at encouraging social capital, including foreign investment, to participate in providing diversified healthcare services. However, relevant market players still need to obtain various qualifications and fulfil registration and approval procedures to demonstrate their technical capabilities and ensure compliance with regulations.

Pharmaceuticals

In the pharmaceutical area, depending on their specific business scope and business type, different certifications and qualifications are required:

For businesses engaging in pharmaceutical R&D, they will need to obtain a Good Laboratory Practices for Nonclinical Drug Research (GLP) certificate issued by the National Medical Products Administration (NMPA) for doing preclinical trial; a record-filing with local health bureau for the use of pathogenic microbiology and an approval from local department of science and technology for use of experimental animals in laboratories; a Radiation Safety Permit from local environmental protection bureau if the drug R&D process involving radiative materials; and import-export related licensing and approvals if the drug R&D involves in imported raw materials.

For businesses engaging in pharmaceutical manufacturing, they will need to apply for a Drug Manufacturing License from provincial NMPA and then comply with the Good Manufacturing Practices (GMP) standards. They also need to obtain a Work Safety License for the production activities, and relevant import-export licenses if needed.

For businesses engaging in drug supplying and trading, they will need to apply for a Drug Trading License and comply with the pharmaceutical Good Supply Practice (GSP) standards.

Medical devices

Medical devices in China are subject to classified management: medical devices are divided into three classes based on the level of risk they present to patients or users. Class I is the lowest risk class and is subject to record-filing management, which is comparatively easier, and Class II and Class III are the higher risk classes and are subject to product registration management, which involves a longer and more rigorous process.

Upon registration, the business will obtain a Medical Device Registration Certificate for relevant Class II and Class III medical devices. Also, businesses will need to file a record with local NMPAs for trading Class II medical devices while they need to obtain an approval for trading Class III medical devices.

Medical institutions

As for setting up medical institutions, foreign investors will need to obtain an Approval for the Establishment of Medical Institutions and a Practicing License of Medical Institutions from local health authorities.

Medical institutions will additionally need to obtain multiple licenses based on their business scope, such as the license for radiological diagnosis and treatment, license for maternal and infant health technical service institutions, license for occupational health examination and diagnosis institutions, and license for purchase and use of narcotic drugs and category I psychotropic drugs.

However, under the “many-in-one” reform, most of these post-establishment licenses, except the Large Medical Equipment Configuration License, have been integrated into the Practicing License of Medical Institutions. That is to say, upon getting approval for relevant applications, the authority in charge will affix relevant information on the Practicing License of Medical Institutions, rather than issuing separate licenses.

Crackdown on corruption in the healthcare sector

Businesses operating in the healthcare industry should also pay attention to anti-corruption management, as China sees corruption in the medical fields as one of the main factors that undermine the reliability and efficiency of the country’s medical system. The government has taken a strong stance against anti-competitive behaviours and corruption in the medical field, leading to increased scrutiny and low tolerance for such actions.

In August 2020, the Central Supervision Commission (CSC) issued a notice emphasizing the importance of strict anti-corruption investigations in the medical field. In October of the same year, the CSC issued another statement calling for the investigation of power-money transactions, the establishment of a list of dishonest individuals, and the cutting off of the benefit chain of medical bribery.

Companies in the healthcare sector are thus at a higher risk of being implicated in commercial bribery and subject to administrative or even criminal penalties. Therefore, it is crucial for relevant enterprises to include anti-corruption measures as an essential part of their overall compliance system. They should also continuously monitor the authenticity, rationality, and verifiability of their employees’ behaviour in subsequent marketing processes.

Key takeaways

China’s healthcare sector is highly regulated and competitive and is among the most promising markets in the global healthcare sector. To succeed in this market, foreign investors must be proactive and agile, planning strategically, acting quickly, and working diligently.

In addition to the considerations mentioned above, foreign investors should stay abreast of the latest policies, not only those related to the administration and compliance of the healthcare sector, but also those outlining the government’s industry priorities. They should adjust their strategy and operations accordingly.

Furthermore, innovation is a key advantage for foreign investors, especially those with expertise in a particular area, but smaller in size. It is wise to capitalise on their creativity by customising their products to meet the needs of the Chinese market and addressing existing challenges. They should also develop a comprehensive intellectual property strategy early on to maintain their competitive edge.

Finally, foreign investors who are unfamiliar with the Chinese market are advised to partner with local companies and hire professional agencies to facilitate market entry and compliance management. However, they should conduct due diligence to verify the reliability and qualifications of potential local partners and professional agencies.

This article was originally published by China Briefing from Dezan Shira and Associates with the title ‘Key Considerations for Entering China’s Healthcare Market’

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Against a backdrop of China’s rapid economic growth, sharp increases in funding, improvements in medical outcomes and evolving demographics, the Chinese healthcare and pharmaceuticals markets have seen rapid advances over the past decade.

Learn more about UK-China collaboration in healthcare and biosciences at the UK-China Business Forum 2024 on 20 March. Click here to register

China’s healthcare market is now the second-largest in the world. Total revenue was estimated to be around RMB 10 trillion (approx. £1.09 trillion) in 2021, and the “Healthy China 2030” initiative, one of the government’s main blueprints for developing the healthcare industry, has set out an aim for the market to reach RMB 16 trillion (approx. £1.75 trillion) by 2030.

This growth, along with China’s sophisticated digital infrastructure, has laid a fertile ground for innovation in healthcare and life sciences.

The UK has a unique health and life sciences ecosystem, and its track record of scientific breakthroughs serves as a driving force for the next generation of life-changing treatments, technologies and services. Recent developments in China’s healthcare sector, including newly published regulations in central procurement and public hospital reform, have made the international business environment even more competitive for international businesses operating in healthcare and the life sciences. Despite growing competition internationally, the UK maintains a competitive position in China’s healthcare cooperation agenda.

The challenges facing the healthcare sector in China provide many potential opportunities for UK organisations. For example, China’s rapidly ageing population will need to be supported by innovative pharmaceutical and biotech solutions, as well as robotics and AI. Sales of home healthcare devices for older adults have already shown an increase during Singles’ Day in recent years, as have sales of dietary supplements and cosmetics with ‘anti-ageing’ properties. Indeed, many experts recommend that the best solutions to the problems of ageing are found much earlier in life, creating a need for innovative products that prevent chronic illness caused by environmental and lifestyle issues.

It is for this reason that, over the past decade, UK-China collaboration in healthcare has received unprecedented support from both governments, as well as leading companies in the industry. For example, in 2017, GlaxoSmithKline (GSK) and the British Council launched the UK-China Health and Economy Partnership, a higher education programme to promote knowledge sharing and research innovation in health economics between leading British and Chinese experts and institutions.

During the UK-China Business Forum 2024, a panel of experts will discuss how UK businesses are innovating and partnering in the Chinese market and how competition is driving healthcare forward in one of the world’s most dynamic economies. The panel includes Mark Hedley, Deputy Head of Investment Promotion at InvestHK; Sue Welburn, Vice Principal of Global Access & Professor of Medical & Veterinary Molecular Epidemiology at the University of Edinburgh; and Elinor Greenhouse, Senior Adviser, Tech and Innovation at the China-Britain Business Council (moderator). Click here to register.

Photo by National Cancer Institute on Unsplash

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In addition to enjoying a rich culture and history, TCM is also a billion-dollar market that offers some surprising opportunities for Western medical and consumer brands.

What is TCM and how big is the market?

TCM is an alternative medicine practice that combines a range of remedies and physical treatments, with a history dating back more than 2,000 years.

Among the many kinds of TCM treatments on offer, herbal medicine is both popular and accessible. Pharmacies and online shops sell a wide range of prepared herbal remedies – some prescription only, some over-the-counter – that come in forms such as drops, tablets or granules, many of which are mixed with water to form a drink or soup.

In terms of physical therapies, acupuncture, a technique involving inserting thin needles into specific body points to balance energy flows, is widely practised, as is cupping therapy, characterised by creating suction on the skin to improve blood circulation and promote healing, which has also gained international popularity (especially since telltale cupping marks have been seen on the backs of professional athletes like Michael Phelps and Hollywood stars like Gwyneth Paltrow).

TCM doctors may also prescribe specific diets, such as avoiding meat or spicy food.

TCM coexists with Western medicine in China, complementing and contrasting with it. In hospitals across China, TCM is offered alongside Western medical services, and patients often combine both types of treatments to avail comprehensive healthcare, since TCM is said to be grounded in the principles of balance and identifying the root causes of conditions rather than treating the symptoms.

Due to this broad range of treatment options and cultural backdrop, the TCM market in China is huge. According to some reports, in 2019, the total volume of TCM commodity imports and exports in China was worth US$ 6.174 billion (£5.028 billion). TCM products are thought to account for around 40% of drug sales in China.

Moreover, in recent years, it has experienced unprecedented growth, fuelled by an ageing population, health fears around the Covid-19 pandemic, and rising support for Chinese culture and made-in-China products (often referred to as the ‘guochao’ movement).

The most valuable company in the TCM market is Yunnan Baiyao, which has a market cap of over RMB 91.42 billion (£10.2 billion). Other major companies include Beijing Tongrentang and Guangzhou Baiyunshan.

TCM Market challenges

Despite its size, the TCM market is not without its challenges. Regulatory hurdles, quality control issues and international scepticism are significant impediments. Standardising TCM practices and products for quality and safety assurance is a primary concern for the Chinese government. Furthermore, scientific validation of TCM principles and methods, compatibility with Western medicine protocols, and global acceptance and integration are ongoing challenges.

How Western brands can navigate the TCM market

A market that is so inherently entwined with Chinese culture and history may seem like one that is difficult to access for Western brands. But for those that understand its cultural, historical, and social intricacies, the opportunities are there.

In recent years, collaborative approaches that respect and integrate TCM’s essence while introducing trendy products or formats have proven very popular with Chinese consumers.

In sum, any Western brand considering the TCM market needs to consider the following principles:

1. Integration: Combining Western technologies and TCM principles to offer hybrid solutions that actually meet patient needs.
2. Education: Educating the market on the benefits of Western medicine, while being receptive to the values and benefits of TCM.
3. Partnership: Collaborating with established TCM brands to co-create products and services that are culturally sensitive and globally competitive.
4. Innovation: Infusing Western medicine with innovations that are compatible with TCM’s holistic, personalised, and preventive focus.

The TCM market in China is a dynamic and evolving entity. Western brands venturing into China’s medical market have the opportunity to create uniquely cross-cultural, multi-dimensional medical solutions by approaching TCM with respect and openness. As the health concerns of China’s ageing population grow, there will be opportunities for Western brands to penetrate this market.

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“It’s hard to not be impressed by the progress that has been made in China over the last few years,” he said in April.

Some Western governments have been publicly decrying the threat of “economic coercion” from China, with countries including the US scrutinising Chinese investment into its biotech centre. However, for AstraZeneca, the geopolitics of the situation is secondary to the market potential.

“When you are a global company like AstraZeneca you have always to cope with geopolitical risk and you have to try to manage that without getting too involved,” Michel Demaré, the company’s new chair, told the Financial Times. As long as there were no legal or sanctions issues, he added, “you just try to take care of your patients and try to reach the most patients you can”.

AstraZeneca is the largest overseas pharmaceutical company by sales volume in China. A large, ageing population with chronic illnesses due to environmental and lifestyle issues ensures that China is a target market for many drug makers. AstraZeneca, however, is also interested in the scientific expertise in China and the financial support available. “The innovation power has changed,” Demaré told the FT. “It is no more ‘copy, paste’. They really have the power to innovate and put all the money in. There’s a lot of start-ups and we are a part of that.”

In 2021, AstraZeneca opened a major R&D centre in Shanghai and launched a health tech incubator in Wuxi the year before that. And last month, it signed a partnership worth up to US$ 600 million (£484.5 million) with Shanghai-based LaNova Medicines for the global licence for a potential cancer drug.

“When you are a global company like AstraZeneca you have always to cope with geopolitical risk and you have to try to manage that without getting too involved”

Since Soriot took over the company a decade ago, AstraZeneca has continued to invest in research and development in China and seen its success grow. Global executive vice-president Leon Wang, who joined in 2013, has also been credited for his innovative approach and has overseen the building of thousands of centres within hospitals to deliver AstraZeneca’s Pulmicort, a drug for asthma and chronic obstructive pulmonary disease.

Soriot said that AstraZeneca’s presence in China enables it to “tap into this innovation and help those companies develop and commercialise their products globally”.

AstraZeneca is not seen as a purely foreign company in China because of the sheer number of acquisitions and partnerships with local companies, and they create incubators that support local start-ups.

The Chinese approval process for getting new medicines onto shelves has reduced significantly in recent years, and the regulatory changes regarding insurance coverage have also helped pharmaceutical companies find success in China. Moreover, AstraZeneca’s ability to operate with freedom in China without restrictions from head office has enabled it to act in many ways like a local company. And without the distraction of geopolitics, AstraZeneca is going from strength to strength.

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The large and active Chinese millennial population has embraced a healthier lifestyle, joining gyms and fitness classes or buying their own fitness equipment. As a result, China’s sports and fitness market has seen exponential growth, from about 500 gyms in 2001 to more than 100,000 fitness studios in 2022.

The Covid-19 pandemic changed much about how consumers live, including how they work out. Now more than ever, customers are using smart interactive fitness equipment to exercise at home. The smart fitness and sports industry, which includes fitness apps, wearables and smart exercise equipment, will amount to US$5.2 billion in 2023.

Some of the major players include Garmin, Life Fitness, Peloton Interactive, Nautilus, Technogym, Xiaomi, BH Fitness, Tonal, NordicTrack, Echelon, Bowflex, Hydrow and SoulCycle.

China’s fitness boom is also being encouraged by the government, which announced a five-year plan to invest RMB 1.5 trillion (£171.1 billion) to improve its citizen’s fitness levels and fight obesity. The plan focuses mainly on teenagers, who will likely carry on these fitness habits as they age.

Smartwatches are the leading product in the smart fitness and sports industry

The future of the digital fitness market in China looks promising, with opportunities in smart wearable fitness devices and smart wearable sports devices. The major drivers for the growth of this market are increasing awareness of fitness and rising demand for user-friendly and self-monitoring devices.

Emerging trends include integration and cross-compatibility of personal health data and the introduction of cross-over products.

Smart wearable fitness and sports devices are the most popular products in the market. Experts forecast that the smartwatch segment is expected to witness significant growth due to their versatile features as a wristband.

Within the digital fitness market, smartwatches are expected to remain the largest segment by product type. Multi-functionality, growing health awareness and rising disposable income are the major driving factors spurring growth in this segment.

A wearable fitness tracker may follow several activities depending on the user’s requirements, including goal-setting, sleep tracking, activity tracking, calorie tracking, heart monitoring and step counting.

Fitness apps have also experienced increased popularity during the Covid-19 pandemic. Over 100 million mobile users have at least one fitness app on their phones, and new apps and platforms are popping up daily.

Apps also play an important role in the Chinese government’s push to get the older population more active. Faced with an ageing society, the government wants people of all ages to get active, and they are building new facilities, offering sports programmes, and planning to invest more than RMB 5 trillion in the sports and fitness industry by 2025.

What are the most popular activities in the smart fitness and sports market?

Two of the most popular activities in China are yoga and dance. Since March 2020, there has been an increased interest in yoga in China and revenue in the yoga industry in China reached almost RMB 50 billion (£5.7 billion) in 2020. People had to look for ways to stay active and deal with the stressful atmosphere during prolonged lockdowns. Those who picked up yoga during the pandemic will most likely continue doing it, even now that restrictions have been lifted.

In China, yoga is seen as a way to relieve stress, cultivate an attractive body and keep fit, which is why so many fitness centres offer different types of yoga and dance classes. Even though cardio and bodybuilding sessions are available, most users prefer yoga and dance.

Since the beginning of the pandemic, the online fitness market experienced a substantial increase in users, with online yoga being the most popular. Videos of KOLs doing yoga while promoting sportswear and fitness equipment went viral on Chinese social platforms such as Douyin (aka TikTok) and Xiaohongshu.

According to a report from the short-video platform Douyin, the number of fitness videos on the platform in 2022 rose by 134% year-on-year, while the number of content creators for these videos rose by 39%. Compared with the previous year, there was a 208% rise in the number of followers of online fitness trainers. Revenue from live fitness broadcasts on Douyin also rose by 141% year-on-year, with rapid sales growth for many types of exercise equipment.

According to the 2022 Spring-Summer Sports and Fitness Consumption Trend Report published by the Jingdong Institute of Consumer and Industrial Development, sales of yoga and dance products have risen rapidly. Sales of yoga pants grew by 868%, yoga shoes by 816%, and yoga bags by 104%.

Fitness apps such as Keep, Codoon, and Mi Fit are popular among Chinese consumers. Users can access training tips, find online fitness courses and connect with other fitness enthusiasts and professional trainers via their smartphones. This business model also helps companies expand customer relationships on a different level than before.

Companies leading the way in this field include Lululemon and VAHA, who have created mirrors that double as interactive training screens, and JAXJOX, a buildable home fitness equipment provider based around a touchscreen TV. Fiture is another active brand of fitness mirrors in China, while fitness brands such as Codoon (a fitness app) and Lefit (a chain of gyms) in China have also released smart training mirrors.

Which other areas of the industry can brands tap into?

Many new brands have appeared over the past few years, continuously attracting new investment. Besides fitness apps and smart home fitness equipment, there are many gaps in the market waiting to be tapped.

Some home design brands are developing creative furniture collections that can be turned into training equipment, while beauty brands are launching fragrances inspired by fitness activities like yoga. Some laundry brands have even developed special formulas to deal with the smells generated by sweaty fitness clothes. There is also a lot of scope for new products in the sports nutrition sector too.

New-style fitness gyms supported by digital technology have seen a lot of success in recent years. The aforementioned Lefit, a 24-hour self-service gym chain based in Hangzhou, is emblematic of the new type of gyms that are attracting young users. People can enter a Lefit gym simply by scanning a QR code with the brand’s app.

The brand also has an intelligent management system that can precisely match its users, gyms and fitness instructors, guaranteeing higher operational efficiency and lower costs than conventional gyms. It also offers a pay-per-use model. To date, the brand has opened 754 gyms across the country and attracted more than 6 million users.

Technology is also influencing the sportswear industry. With the help of big data and kinesiology, underwear brand Aimer is striving to develop new materials with less friction and higher air permeability for its yoga and running garments.

How to succeed in the smart fitness market

For companies in the health and fitness industry, now is a great time to enter the Chinese market. Nevertheless, there are some key steps that need to be taken to be able to sell fitness apps, equipment or clothing in such a highly competitive landscape.

Chinese consumers rely on word-of-mouth marketing and pay attention to recommendations and reviews of people they know or influencers they follow. They won’t buy or pay for anything they have never heard of.

Building a strong online presence for your fitness product is the most important step. The best way to do so is by launching your own Chinese website hosted in China so that consumers can find you on Baidu. You can also use other Baidu platforms, such as online forums and Q&A websites, to start conversations about your brand and learn about the needs of your potential consumers.

For Chinese consumers, the quality of items they buy, as well as the service they get when purchasing, are the most important components. In general, they don’t mind paying a bit more if they think that something is a good investment. Therefore, promoting a high-quality brand is key.

While promoting your brand, highlight its values and educate the audience about the benefits of using your products/service. You can show videos of professional athletes using them (even better if you collaborate with Chinese athletes or sports influencers) and share the opinions of experts.

Advertising your fitness business through social media, especially on platforms such as WeChat, is another great way to increase your visibility and make yourself known to Chinese users. Many Chinese people follow literally dozens of fitness blogs. Every day, they will look at their news feeds to learn about new workout routines or trendy diets.

You can also use those apps as a testing platform. WeChat allows companies to start official accounts and create WeChat stores, a cheaper option than entering big online marketplaces like Tmall or JD.com, and a way to get an idea of the level of interest in your products. If you want to promote your app, try to build it within WeChat first. This will help you reach a bigger audience, as it’s easier to share and promote within the app.

You can also open accounts on platforms such as Xiaohongshu and Douyin. Those platforms are great for lead generation and reaching a wider audience through different content formats. Xiaohongshu and Douyin also have their own marketplaces, making promoting products and increasing sales easier.

As the fitness market has boomed, so has the number of sports influencers. More and more influencers are popping up on Chinese social media, especially after the Covid-19 pandemic and Winter Olympics in Beijing.

Collaborating with fitness influencers to promote your brand on their social media accounts is one of the best ways to gain visibility and increase sales in China. Influencers can host live streaming sessions showing off your products or use your products while training. You can also collaborate with local gyms and fitness centres, introducing your products to personal trainers that can later promote them to their customers.

Although all the mentioned options are essential for branding and e-reputation, nothing will give you as much exposure as Chinese cross-border e-commerce platforms like Tmall and JD.com. Most Chinese shoppers prefer to purchase products directly from these, as they feel they are safer and more convenient.

China Consumer 2023

This article was produced as part of a series for China Consumer 2023.

Learn more about CBBC’s flagship consumer event of 2023 here.

The post Practical guide to China’s smart fitness and sports market appeared first on Focus - China Britain Business Council.

In this fifth instalment, Haleon talks to FOCUS about China’s consumer health industry and how our health as individuals can’t be separated from the future health of the planet.

Tell us how and when Haleon entered the China market…

While Haleon is still a young company, our history in China dates back 35 years. Our products have served hundreds of millions of Chinese consumers for over three decades. With a unique purpose of delivering better everyday health with humanity, our brands are trusted by consumers and recommended by healthcare professionals. 

What major successes and growth have you had during this time?

We have established a broad product portfolio covering oral health, pain relief, respiratory health, skin health and vitamins, minerals and supplements. Over the past three decades, our category-leading brands, such as Caltrate, Centrum, Sensodyne, Polident, Contac, Fenbid, Voltaren and Bactroban, have been trusted by millions of Chinese consumers. We have three manufacturing sites in China serving both the Chinese and international markets, as well as a global R&D centre based in Suzhou.

Haleon achieved a 9% global organic revenue growth in 2022, with a healthy balance of both price and positive volume/mix. In China, our brands such as Caltrate and Voltaren continued to see strong growth with mid-to-high single-digit growth. At the same time, Haleon’s e-commerce business in China grew significantly, by 40%.

We not only pursue business success, but also strive to practice corporate social responsibility in multiple dimensions, including environmental protection and health inclusivity. Our Suzhou plant achieved carbon neutral status for the year 2021, becoming the first carbon neutral company in China’s consumer health industry. Moreover, we have launched several social responsibility programs dedicated to making every day health more inclusive, more achievable and sustainable, such as the Bone Health in China campaign launched since 2012, focusing on osteoporosis prevention and treatment.

Haleon’s Suzhou plant

What are your thoughts and reflections on the Chinese market today?

China is one of the most important markets for Haleon. We see China evolving quickly with rising demand for quality, and combinations of new trends such as e-commerce, sustainability, diversity and demographic changes that will provide multinational companies with tremendous space for further development. 

We recognise that to run business well, we need to understand the local market well. For example, compared with other markets, China has some unique consumer behaviours; omni channel shoppers and new and emerging social commerce platforms are growing extremely rapidly, for example. Digital health and technology are also demonstrating increasingly strong growth.

How has CBBC supported you during this time?

Since its establishment, CBBC has positioned itself on the centre stage of UK-China bilateral trade and investment. It strives to shape a more favourable environment for British companies doing business in China, including Haleon. 

CBBC’s close links to the UK and Chinese governments at each level, as well as its track-record of facilitating constructive engagements with influential stakeholders, have benefitted its member companies. 

In addition, CBBC also takes advantage of its expertise and insights to provide services to us vis-à-vis market advice, policy analysis, access advocacy from their unique perspectives. In a nutshell, Haleon has benefited from CBBC’s service in supporting our commercial success here in China. 

What are your ambitions and plans for the future in China? 

China is one of the most important markets for Haleon, and our consumer health business has been deeply rooted in the Chinese market for decades. 

Moving forward, we will continue to leverage our strengths of trusted science, deep human understanding and digitalisation to drive innovation and embrace the Chinese market based on China’s local needs and better empower Chinese consumers’ everyday health.

Haleon recognises that our own health and the health of our planet are inextricably connected and therefore has made a commitment to sustainability by reducing carbon emissions, making our packaging more sustainable and circular, sourcing, using and disposing of our ingredients responsibly, and reducing water and waste usage in manufacturing. We aim to reduce our net Scope 1 and 2 carbon emissions by 100% and our Scope 3 carbon emissions from source to sale by 42% by 2030; and will develop solutions for all product packaging to be recycle-ready by 2025.

What do you think China will look like in another 50 years?

We are very excited and confident about the future of the Chinese market. From our perspective, as the Chinese market opens up to further high levels, Chinese consumers’ demands for everyday health will increase, becoming more sophisticated and diversified.

In addition, with the achievement of the Healthy China 2030 and Double Carbon goals, China is poised for great success in improving healthcare accessibility and green transformation in the near future.

Haleon looks forward to continuing to contribute to the development of China over the next 50 years. We will also leverage Haleon’s unique strengths to play a key role in the fast-growing field of consumer health and better serve the daily health of the Chinese people.

The post In Conversation with Haleon appeared first on Focus - China Britain Business Council.

You don’t need a science degree to understand the life-saving benefits of Beijing X-Magtech Technologies’ commercial-grade atomic magnetometer.

Possessing sensitivity about a billionth of earth’s magnetic field, it acts like a tiny microscope with the ability to detect extremely weak magnetic fields. The outcome for doctors around the world? The chance to detect cardiovascular and brain diseases such as Alzheimer’s with more precision, more quickly and in the most non-invasive way possible.

However, what’s perhaps most impressive about this groundbreakingly affordable magnetic sensor is that it’s been developed by a small, Beijing-based company that only started in 2020, has raised capital from high-profile investors such as IDG and has already won a British Business Award. The device is now being used by hundreds of patients a day in some of China’s key hospitals, with patents pending in Europe and the US.

Beijing X-Magtech Technologies’ commercial-grade atomic magnetometer

Providing scientists and engineers with a powerful tool to investigate new physics and engineering applications, it’s not just the medical field that the technology will impact either: everything from geophysics and materials testing to the defence industry are potential beneficiaries going forward.

The company was co-founded by Bin Cai, a Xi’an-born entrepreneur who studied Aerospace Engineering at the University of Bath before working at Rolls Royce and Jaguar Land Rover in the UK for over 12 years. Bin is clear about the influence his UK education and work experience had on X-Magtech’s creation: “My experience helped me gain an international perspective and an open mind in terms of what was possible, which was crucial for creating something so innovative and disruptive,” he says.

Bin says collaborations in scientific research and education between the UK and China have also played a key role in his company’s origin story.

“All four co-founders of our company have their highest degree from the UK, and each of us spent at least four years in the UK on average,” he says, adding that, combined with his cultural knowledge of how to do business in his home country, he and his co-founders were able to combine the technical and commercial skills needed to get the atomic magnetometer into hospitals back home.

However, Bin’s journey hasn’t been without its difficulties.

“The greatest challenge was how to establish a technology start-up aimed at disrupting the market and changing the sector,” he explains. “Most people in China believe that products like this have to be developed by famous universities or research centres rather than a small company with no government support or research grants – which made our first fundraising round very difficult.”

After investing RMB 10 million (£1.2 million) of their own money on a prototype to demonstrate the product’s capabilities – and a lot of persistence – the four founders were able to get the first group of investors on board.

Since then, Bin says, the UK and China’s relatively stable economic relations throughout the pandemic have helped his company move forward more efficiently, since X-Magtech has a very specific supply chain for components from the UK.

“We depend heavily on each other’s technical breakthroughs, commercial validation, supply chains and, most importantly, talent,” he says, adding that supporting companies like X-Magtech benefits not just the UK and China, but other countries too.

“Products like ours help everybody. Our contribution to the field has been to provide an affordable and robust commercial solution so the technology can be applied in the real world faster and benefit more patients – ultimately saving more lives.”

X-Magtech’s Magnetocardiography (MCG) system – for measuring magnetic fields caused by electrical currents in the heart – was cleared by the CFDA (China Food and Drug Administration) for market entry in early 2022, and the company estimates 20-30 hospitals will become their customers in 2023. They hope to reach as many as 1,000 hospitals in the next five years.

“This year our MCG system will be installed in many more hospitals, and we will keep developing the product, especially with a large dataset from across the country that could allow us to improve the accuracy of a [patient’s] diagnosis,” Bin says.

“Our MEG product will also come to the market this year so there will be a lot of work to do, but we are excited to see our quantum technology helping scientists and doctors better understand our brains and to treat brain disease with this new tool.”

So how can companies like Bin Cai’s be helped to reach their goals more quickly?

“It may sound like I’m being diplomatic, but I really would like to see us continue being great collaborators in these areas, and where necessary to agree to disagree.”

“But it would also be very helpful if there were more opportunities for companies like ours to showcase our products to relevant audiences in the UK, since quantum technology is a key strategic area and the UK has a great medical market and industry.”

The truth is, with robust support behind Bin Cai and his 50-strong team, there really is no limit to what X-Magtech can do for global good.

The post How UK-China scientific collaborations are benefitting the world appeared first on Focus - China Britain Business Council.

The size of the Chinese healthcare industry is second only to the US, reaching a value of RMB 7.82 trillion in 2019. British medical device manufacturers have traditionally taken a cautious approach to the China market due to IP concerns, competition risks and fear about language and cultural barriers. But the market opportunity is huge for those who strategically structure their approach, instead of treating the market like another non-core area and delegating all activities to their distributor.

This article introduces the key steps manufacturers should take to help their medical device get approved by the China regulator by being seen as safe and effective for China sales.

Step 1: Determine the approval pathway for your device for China

There are three broad pathways to get your medical device approved for sale into China:

1. Standard approval process with the National Medical Products Administration (NMPA)
2. Fast-track (also known as “green channel”) approval pathways
3. Alternative pathways via sales to special areas within Greater China – the Greater Bay Area or Hainan Island Pilot Zone – that may enable easier registration via subsequent standard or fast-track approval processes.

The three main approval pathways to register a medical device in China

The vast majority of imported medical devices will seek to apply via the standard pathway to NMPA in Beijing. To do this, products should first have home country approval. For higher-risk devices (class II or III – see below for more information about classification), approval in China will probably require a detailed clinical evaluation report to be prepared or a clinical trial in China to be undertaken.

For “fast-track” pathways, only the newly introduced “Innovative” approval pathway allows devices without home country approvals to submit for China approval. Success in such applications requires a China patent, as well as evidence that the product is a first of its kind for application into China.

Other fast-track (also known as “green-channel”) approval pathways in China include priority review or emergency approval applications. Emergency approvals are reserved for special situations like the Covid-19 pandemic, and specific categories or types of devices will be announced by the NMPA as eligible for application. Once approved for emergency use, subsequent renewals will require the standard full documentation similar to standard applications.

The alternative pathways of the Hainan Pilot Zone and the Greater Bay Area are frameworks enabling companies with home country approvals to sell in limited circumstances. This can aid the collection of real-world data on China populations, which can reduce eventual China clinical trial requirements for subsequent NMPA standard or “fast-track” applications.

Step 2: Classify the device into the appropriate risk class and establish whether China clinical trials are required

Your medical device will need to be registered in your home market before you can apply for China marketing approval, subject to the exceptions explained above.

The risk classification in your home country jurisdiction will often be similar to China’s three risk classes, with class I being the lowest risk and class III being the highest risk (although not necessarily equivalent). According to the NMPA, the degree of risk is assessed based on “the intended purpose, structural characteristics, pattern of use, status of use as well as whether the device is body contacting.” China tends to be more conservative than other countries and so risk classification can be up-classified depending on the type of device.

There is an extensive risk classification catalogue which is sufficient to determine the appropriate class for most medical devices, but according to your author’s experience, in roughly 5% of cases it is necessary to apply directly to the regulator for a determination.

How to classify a medical device in China

If your product is a class I medical device then it will go through a simple filing process in China. If it is a class II or class III product, then it must go through a registration process which means there is a review of the product documentation by the NMPA prior to marketing approvals.

Class II and III device applications will need to be exempt from clinical trials, rely on predicate device data or be supported by clinical trial data (see Figure 3 for whether a clinical trial may be required).

For companies that are unclear about whether China clinical trials are required, Cisema recommends preparing a feasibility study of the pathways and data available.

Step 3: Understanding the key steps for filing and registration

The filing process for class I is relatively straightforward and consists of a dossier preparation stage followed by submission to NMPA. This is represented in Figure 4 below. The total timeline is usually around 2-4 months.

Filing process for class I submissions in China

For class II and III medical devices, the registration process is longer and more rigorous. First, there is the documentation stage, including drafting of the product technical requirements (PTR), which is a key technical protocol outlining the local testing specifications and relevant China standards. Then follows local testing of product samples in China – a mandatory requirement – following by clinical evaluation drafting or clinical trials, before submission of the dossier to NMPA for review and approval.

In certain cases, a class II or III product may be expressly exempt from clinical trials in China. In such cases, a simplified clinical evaluation report or even no CER at all will be required.

Timeline of China registration of class II & III medical devices

Step 4: Select your local China representative

In parallel with the registration process, manufacturers will need to carefully consider the identity of their local authorised representative – more accurately known as the NMPA Legal Agent. Like the EU and US, applicants must be represented by a local China entity for the purposes of submission and approval in China.

Importing manufacturers have three options: distributor, local subsidiary or service provider. The distributor option is often the default, but manufacturers should be cautious of potential IP risks (a lot of production information needs to be provided to the NMPA Legal Agent as part of the application process – and the dossier must be submitted by the agent) as well as for flexibility and regulatory expertise following marketing approvals. The NMPA Legal Agent will be involved in the first import of the product for each new distributor named, so flexibility will be limited for such a huge market if there is one master distributor who in effect needs to approve the others.

Also, NMPA has increasingly moved to a whole of lifetime perspective rather than point-of-time approvals. This means there will continue to be ongoing updates and requirements during the product’s lifetime even after marketing approvals are obtained. A typical list of your NMPA Legal Agent’s services should cover adverse events and recall management, labelling and regulatory mandatory updates, standards updates, periodic reporting and more.

Unless manufacturers want to make a substantial investment in their own subsidiary in China, a better option is to nominate an independent service provider who has deep regulatory expertise and fewer conflicts of interest.

In summary, UK manufacturers should think strategically about their China medical device registrations but not be swayed by hearsay or general fears. Registration of your device in China is realistic and achievable with the right approach and investment. Only then can China’s vast market potential be realised.

The post How to get your medical device approved for sale in China appeared first on Focus - China Britain Business Council.