Regulatory

China’s National Medical Product Administration (NMPA) is the main regulatory and administrative body that creates, implements, and governs the standards of all medical devices, cosmetics, and drugs in China. NMPA are responsible for most of the pre-market approval and post-marketing activities, thus, businesses operating within this industry will likely be required to encounter the NMPA in some way or form.

 

Medical Device Classification

The Regulations on Supervision and Administration of Medical Devices (State Council Order No. 680) is the highest level of governing rules for the registration and record keeping of medical devices.

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Expedited Pathways to China Market Entry

Businesses handling certain types of medical devices may be granted access to an expedited process. "Innovative device pathway" is a common practice.

Pursuant to the Special Evaluation of Innovative Medical Devices, to qualify for this fast-track process, medical devices must first belong to either Class II or Class III, and satisfy three main criteria:

  1. Domestic invention patent of core technologies granted within five years;

  2. Novelty of such product in the PRC, is in a leading position worldwide, and demonstrates significant clinical practical value; and

  3. The applicant has prototype of the products after completion of early stage research and has complete and traceable research data to back it up.

According to government statistics, from 2014 to mid-2019, a total of 222 products have applied to enter this entry pathway, and 65 products have been approved for listing. Among them, 64 are domestically produced products, including high-value medical consumables, such as branched aortic stent grafts and interventional artificial heart valves.

 

Reforms of Chinese Pharmaceutical Industry

New drug registrations from outside of China

The NMPA created a new policy explicitly for new drug registrations from countries outside of China in 2016. This policy opened the first-in-human Phase I trials to new drugs developed outside of China and also simplified and reduced the clinical trial and drug registration process. Hence, international sponsors can submit an NDA in China without the condition of drug approval in the US or any other country.

Trial data acceptance from outside of China

Later in 2017, the NMPA introduced a new policy recommending the acceptance of clinical trial data from trials conducted outside of China, which further supports a significant improvement in the approval process. According to the proposed draft policy, a sponsor can use certain data generated in clinical trials conducted outside of China for the drug registration process in China after the NMPA’s audit. 

 

An optimized and integrated strategy of capital and regulatory is the key to expedite the market entry.