Comparison of regulatory framework of medical device between China, US and EU

Before investment of medical device in China it is wise for overseas stakeholders to gain a deep overview of Chinese regulation. In fact there are more similarities of Chinese regulation of medical device compared to it at European - and American market. For overseas manufacturers who consider marking their products in the future in China, we would like to analyse essential items as legislative, Chinese agent, prerequisite of product registration, product code, challenging registration steps etc. from preparation of submission dossiers till post market activities.

The new requirements of UDI inplementation and incident reporting in China teach us to proactively discriminate the difference with European - and American regulations. The regulatory gaps compared to westen countries can be quickly taken into force in rapid development of Chinese regulation. The understanding of regulatory difference supports all regulatory personals adjust technical documentation in accordance to Chinese requirements smoothly. 

Who is the authority of medical device in China?

National Medical Products Administration (NMPA) is Chinese authority to supervise medical device placed into market. Among centres under NMPA, Chinese medical device evaluation (CMDE) performs technical evaluation of medical device which is primarily important for overseas manufacturers. Different than in EU there are no decentralized organizations as notified body and countries competency authority. Legal manufacturers have to submit dossiers to and get product approval from central authority NMPA in Beijing.

Ready to start product registration at NMPA?

After sound market research of similar products, sometimes even a strong network with distributors, you have to check the prerequisite of product registration at NMPA in prior to get a regulatory proposal to start preparing the dossiers. The home country approval is subject to provide as an original certificate. As the registration of class II and III medical device need an exhaustive long period, it is recommended that the product certificate is at least one year valid at the starting point of product registration.

Besides fulfilling the prerequisite you should find an entity located in China as Chinese agent. For non-globe player manufacturers of medical device this task can be managed by a consulting firm with more benefits.

Keep these basic knowledges in mind

The regulations of medical device in China are only in Chinese, as well submission dossiers. Instead of translating all orders, guidance and standards in English, it could be intelligent to use new technology of translation tool to overlook them beforehand and see whether it applies to you. We will update all important regulations as newsletter and summarise the scope of the new regulatory changes.

In China medical device is divided to 21 main product groups or categories. One of first steps at regulatory strategy is to determine the 6 digits product code, very similar to product code at FDA. Bound to product code are product specific guidance and standards which are as part of regulatory update to follow. It refers to revised content at submission dossiers, additional type testing units and in best case integrated in quality management system.

Like FDA there are class I, II and III medical devices in China. High risk medical device undergo respectively extensive regulatory requirements at NMPA.

The product certificate issued by NMPA is 5 years valid except for class I MD. Unlike at EU and US the manufacturers have to extend the certificate in time in China which sometimes demands new type testing.

How is quality management system required and monitored in China?

If the manufacturers have no production site in China, a GMP certification is exempted. However as an original certificate, ISO 13485 certificate except for class I MD must be submitted. If medical device was produced in China, a Chinese GMP is needed. After product approval the overseas inspection by NMPA at site of manufacturers could happen as FDA inspection. It is according to the experience rarely occurring which could be strengthened by authority any time.

As of 2023 manufacturer has to submit annual self-examination report, similar to QSD renewal in Taiwan  and QM renewal in Japan.

Which are most challenging parts at medical device registration in China?

Type testing for sure! There is rapid update of product specific guidance and standard in China. It implies often new requirement of validation test called type testing by NMPA accredited testing institutes. The test per se is very demanding. The device should be shipped to testing institutes in China. No testing unit should fail with operation of engineers at testing institutes. The performance and functional specifications should not deviate than required in national and industrial standards.

The second hurdle is clinical evaluation. It is quite similar to Europeans clinical evaluations (MEDDEV 2.7/1) in which conformity of safety and effectiveness requirements are proved in term of clinical data. The problem is to achieve technical specifications and clinical data of similar products with permission of competitors which have equivalent or similar products already approved in China. It is way easier after the initial registration of overseas manufacturers at NMPA, since the former product version can be freely used as similar product to compare to subject new product version.     

What happens after product approval?

As of 01.01.2019 there is obligation for all manufacturers to report incidents. As of 01.09.2020 there is new requirement of period risk evaluation report (PRER, Chinese PSUR). The trend of increasing requirements of post market activities indicates that NMPA has switched to high gear fortifying after approval monitoring.

Periodic market clinical report and adverse event risk assessment are coming!

Unique and typical Chinese

Summarised it is new for European manufacturers to understand role of Chinese agent and function of product code. Depends on intended use and product description the Chinese product code can be actually searched and matched in proper manner.

US manufacturers might understand Chinese regulation with fewer efforts due to more similarities of both medical device markets. Not to avoid is clinical evaluation for fewer medical device as part of submission dossiers which is irrelevant at FDA.

There is no need in China to register manufacturers. To get product approved, the overseas manufacturers have to prepare all documents in Chinese and submit dossiers through electronic regulated product submission (eRPS).

For all manufacturers even for domestic manufacturers, type testing is definitely a huge exam to pass arriving approval destination. However, NMPA is leveraging policy to accredit as many qualitative third party testing institutes as possible to execute type testing.