What China’s domestic agenda means for foreign medical device developers (2024)

What China’s domestic agenda means for foreign medical device developers (1)

As China steps up protectionist policies to grow its domestic industry, international medical device companies find themselves in a precarious position. China is one of the world’s largest medical device manufacturing hubs, and foreign multinational companies dominate the market, with China currently importing over 70% of medical devices.

Since April 2021, the Chinese government has worked on a medical technology five-year plan (2021–25), aiming to make at least six Chinese companies reach the top 50 revenue-making medical device companies globally. Currently, there are four Chinese companies in the top 100, but none in the top 50.

In the last few months, local ministries and commissions in China issued notices prohibiting all public medical institutions from procuring imported medical equipment without approval. This rigid change in procurement policy follows a similar action that China has taken in the pharmaceutical sector to bulk purchase generic medicines. However, China’s medical device model may fail to translate with advanced, patient-centered, and technology-intensive products like medical devices, says Fredrik Erikson, Director of the European Centre for International Political Economy.

“A sophisticated medical device requires training, education, instrument availability and cleanliness, and other post-sales services. Doctors often select a particular type of product to meet the specific needs of the patient and to obtain the best outcome for that patient. To ensure the quality and safety of healthcare, it is important that the procurement process considers the cost of care and outcomes and integrates the quality criteria specific to a given product category,” notes Erikson.

“If the terms of a centralized state tender leads to a narrow focus on the price of the actual device—and not the services that are required to use a complex device safely and effectively—there will be negative consequences. Significant price reductions might seem like a win in the short term. However, procuring at the lower cost might have a high price tag in the longer term for the healthcare system, especially when it leads to longer hospitalization, higher readmission rate ,and longer rehabilitation time, [such as] lower-value medical devices,” says Erikson.

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Europe’s response to China’s policy is a case of urgency, according to experts. “The result of these policies is that European manufacturers of medical devices are deprived of opportunities to compete and win customers in China, sometimes on a national basis. Many of the medtech manufacturers in Europe are small and medium-sized enterprises with little capacity to fend for themselves in China,” states Erikson.

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Additionally, China’s policies will threaten market dynamics across the globe. The loss of sales and market shares in China will create competition from state-backed Chinese manufacturers in third markets. It is already beginning in regions such as Africa, Asia, and Latin America.

Trade data suggests that Chinese exports of medical devices significantly increased during the COVID-19 pandemic, and China’s industry is now able to grow its global market share exponentially as healthcare systems around the world increase their expenditure. GlobalData forecasts that the Chinese medical devices market will grow at a compound annual growth rate of around 6% between 2022 and 2030.

The economic threat to Europe’s medical technology sector is hard to underestimate. The sector employs approximately 760,000 people directly in Europe, with 210,000 employees in Germany, 103,000 in the UK, 94,000 in Italy, and 89,000 in France. Overall, there are 33,000 medtech companies across the continent, 95% of which are small- and medium-sized firms. In 2020, the industry generated a trade surplus for Europe of €8.7 billion ($8.5 billion).

such as the European Commission filing complaints to the World Trade Organisation (WTO) over China’s procurement policy. “While there is no obvious instrument that directly could help to remedy the problem, a combination of measures—including both contingent policies, notably the evolving International Procurement Instrument (IPI), and negotiations—would be necessary to achieve two outcomes,” notes Erikson.

“First, it is required that actions are employed rapidly to avoid the continued deterioration of market access of European manufacturers arising from distorted procurement policies. Secondly, it is desirable for all sides that the long-term development of the market for medical technology goods continues to be competitive, rewards innovation, and provides patients with access to high-quality medical devices that meet their individual needs,” Erikson adds.

India’s window of opportunity

China’s policies may provide an opportunity for emerging markets. GlobalData Medical Devices analyst Rohit Anand tells Medical Device Network how companies may shift manufacturing facilities to other Asia-Pacific (APAC) countries such as India, which could benefit from the increased foreign direct investment.

“Some foreign companies may now see China as a less attractive destination to manufacture and sell medical devices, whereas some other [companies] will be forced to operate as a separate Chinese entity with squeezed profits. It may not be possible for medical institutions to completely replace all high-end imported medical devices with domestically manufactured devices over the next few years, and China will continue to be an import-dependent country. Also, the new policy may create a trust deficit and discourage medical device companies to invest in China,” says Anand.

According to GlobalData research, India was among the top three medical device markets in APAC in 2021. The Indian government announced its National Medical Devices Policy in 2021 to encourage medical devices manufacturers to begin producing high-end medical devices. The field of diagnostic imaging devices is expected to be a key area of interest for both government and manufacturers.

“The domestic manufacturing of high-end medical devices will support India’s aim of becoming a manufacturing hub,” says Anand, adding “India wants to become as self-sufficient as possible. Shortages of medical supplies during the COVID-19 pandemic took a huge toll on the country, and India’s manufacturing capabilities have seen significant development in the last few years.”

The list of incentives announced by the government include subsidies on capital interest; incentives on air cargo, zero waste, and skill development; reimbursem*nt of State Goods and Services Tax (SGST); and a patent filing fee. These incentives will be given to companies setting up units in the state’s first Medical Devices Park. The state government has also offered industrial plots under this scheme at a lower cost.

“Domestic and multinational companies can utilize the Indian government’s move towards domestic manufacturing to gain market share. GlobalData expects that the incentives and the increased availability of skilled local labor will help the state become a preferred manufacturing destination in India,” says Anand.

What China’s domestic agenda means for foreign medical device developers (7)

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What China’s domestic agenda means for foreign medical device developers (2024)

FAQs

What China’s domestic agenda means for foreign medical device developers? ›

Some foreign companies may now see China as a less attractive destination to manufacture and sell medical devices, whereas some other [companies] will be forced to operate as a separate Chinese entity with squeezed profits.

What is the Chinese regulation for medical devices? ›

Medical device and IVD registration in China

Manufacturers must register their devices with the NMPA before selling or distributing in China. The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.

What is the contribution of China in medical technology? ›

Historically China has made immense contributions to medicine in the fields of pharmacology, physiology (such as endocrinology), clinical medicine, public health, medical colleges (including medical education and examination systems), the registration of physicians, acupuncture, moxibustion, and so on.

What is the NMPA regulation in China? ›

China's Health Authority:

In China, Pharmaceuticals are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA).

What are the guidelines on market access for medical devices in China? ›

All medical devices entering the Chinese market are required to obtain pre-market approval, known as medical device registration, from the Chinese Food and Drug Administration (CFDA). The Regulations for Supervision and Administration of Medical Devices is currently the highest level of legislation in this sector.

What are the risk classification of medical devices in China? ›

With classification similarities to US and European standards, China NMPA categorizes medical devices and IVDs into three classes. For medical devices, classifications are based on their potential risk to patients. Class I is the lowest risk, and Class III is the most complex and of highest risk.

Does China require CE mark for medical devices? ›

In the case of registering Class II and Class III devices, manufacturers are obligated to send the appropriate documents showing that the device has been approved in its country of origin (i.e. CE Mark, 510(k) letter, ISO 13485 certification, approved Premarket Approval Application).

Does China have an FDA equivalent? ›

Focus on China

Drugs and medical devices are overseen by the former China Food and Drug Administration (CFDA) now the National Medical Products Administration (NMPA), which reports to the State Administration of Market Regulation (SAMR).

What is the Chinese NMPA human factors guidance? ›

The Chinese NMPA draft human factors guidance states that the medical device is not guaranteed to be safe and effective in China because the use environment, users, and applications may be different in China than in other countries.

What is the difference between NMPA and CFDA? ›

CFDA was a ministerial-level agency that supervised food, drugs, medical devices, cosmetics, and health food. In 2018, CFDA was reorganized and renamed National Medical Products Administration (NMPA). NMPA comes under the legislation of the State Administration.

How big is the medical device market in China? ›

In 2022, the market size of China's medical equipment exceeded 1,170 billion yuan, representing an increase of more than 200 billion yuan from the previous year. China's medical device market more than doubled since 2018, and is expected to grow to almost 1,300 billion yuan in 2023.

How many medical device companies are there in China? ›

As of December 2022, the number of medical device companies amounted to 32,632 in China. Despite some fluctuations, the figures experienced an overall increase from 13 thousand in 2008. Over 90 percent of the Chinese medical device companies are small and medium-sized enterprises.

Can you market a medical device without FDA approval? ›

If your device requires the submission of a Premarket Notification 510(k), you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so.

What is equivalent of FDA in China? ›

Drugs and medical devices are overseen by the former China Food and Drug Administration (CFDA) now the National Medical Products Administration (NMPA), which reports to the State Administration of Market Regulation (SAMR).

What is the accessibility Law in China? ›

The People's Republic of China passed the Law on the Protection of Persons with Disabilities in 1990 to prohibit discrimination against people with disabilities.

Is TCM regulated in China? ›

BEIJING, Feb. 11 -- China on Friday released a regulation on the registration and administration of Traditional Chinese Medicine (TCM), in an effort to strengthen the development of new drugs, according to the country's top drug regulator.

Does China have manufacturing regulations? ›

Numerous government agencies in China mandate industry-specific standards or testing requirements for products under their jurisdiction, in addition to the GB standards and the CCC mark described above.

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