China Regulation Update from the month of December

Stephanie (Xing) Huang

1. State council approved the submitted Order 680 Regulations on the supervision and administration of Medical Device draft version.

In the latest draft version, there are some key changes to review as peak sneak. One change is to the role and status of MAH system is clarified and so is the responsibility of the subcontractors. Another change is to lift the type testing requirements, which allow the applicants to provide test reports from qualified test institutions in or out of China. The penalties for breaching the regulations are clearly set on corporate and personal level. The innovative device may not need its home country market approval as medical devices before entering China. There are more demanding requirements and responsibilities for China agent role. The clinical evaluation reports may not be required for class I and some class II products. For the medical devices used to treat rare diseases, serious life-threatening diseases without effective treatment, and urgent needs in response to public health emergencies, the fast approval could be given with conditions.

2. Notice from State Food and Drug Administration on clarifying the qualification and identification of medical devices CMA stamp on the testing report

NMPA require the testing institution shall issue an accurate, clear and complete testing report independently and objectively, and affix seals properly on the report.  If the product technical requirements completely adopt the national standards and industrial standards, the testing institution must obtain the qualification certification of the relevant national standards and industrial standards, affix the CMA seal on the cover of the report, and indicate it in the remarks of the report.  If the product technical requirements do not or partially adopt the national standards or industrial standards for testing, the test institution shall self –declare the testing capability in the remarks of the report, and bear the legal responsibilities. The content of the self-declaration shall be "the technical requirements of the product do not involve / partially involve national standards and industry standards, and cannot be directly used as the basis for qualification, but the lab has the testing ability for the inspection items involved in the report".

3. Announcement from the State Food and Drug Administration on adjusting 28 products category’s classification of medical devices (No. 147, 2020) is released on 31th December 2020. 

From the date of this announcement, the application for medical device registration and filing shall be submitted according to this newly adjusted category.  For the medical devices that have been accepted but still under review process (including the initial registration and renewed registration), the technical department shall continue to review and approve the products according to the historic classification category. Once the registration is approved, the issued registration certificate shall indicate the new adjusted classification in the remarks column.  For approved devices whose classification is adjusted lower from class III to class II, the existing certificate remain valid within the period of validity. In case of renewal, the registrant shall apply to the corresponding regulatory department based on new classification 6 months before the expiration. If the renewal of registration is approved, the medical device registration certificate shall be issued according to the adjusted product management category. For approved medical devices whose classification is adjusted from class II to class I, the registration certificate shall continue to be valid within the period of validity. The registrant may apply to the corresponding drug regulatory department for product filing, before the expiration of the registration certificate.  For product change within the validity period of the registration certificate, the registrant shall apply to the original registration department for change. The new classification shall be indicated in the remarks column of the registration change documents of the product change approval.

4. The implementation of the first batch of unique device identification (UDI) will be launched on January 1, 2021.

UDI –DI shall be submitted in the application form via ERPS system for the smallest sales unit of listed trial products since 1st January 2021. The application applies to initial registration, change and renewal registration. The application may not be further processed without UDI-DI filled in properly. However, UDI does not belong to the registration technical review scope, and shall be created by the applicant according to the "unique identification system rules for medical devices". A list of required UDI trial products could be provided upon request.

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