【NMPA】Announcement on the Production of Imported Medical Devices in China related matters (NO.104, 2020)
In order to further implement the State Council about the management on drug and medical device examination and approval system reform, promote the development of high quality medical device industry，to better meet the demand of public health, now have import medical device registration certificate products within the territory of China enterprise production announcement of relevant matters are as follows:
1. Scope of application
Imported medical devices through their domestic established foreign-invested enterprises in china manufacturing Class II and Class III certificated medical devices related matters, are adopted of this announcement.
2. Registration requirements
a. The foreign-invested enterprises established within China by the registrant of imported medical devices shall, as the registration applicants, submit the application for registration of domestic devices to NMPA. The contents of application for registration, should be consistent with the corresponding imported medical devices attachments.
b. The registration applicant shall follow the requirements of ‘The announcement of medical devices registration requirements and the approval format of dossiers requirements’ (NO. 43, 2014), ‘IVD reagents requirements and format of the approval documents for registration’ (NO.44, 2014), ect. Thereinto, the overview of the medical devices, research information, clinical evaluation material, risk analysis material, IVD reagents product review materials, key production raw material (when applicable), process flow diagram: including the key process (when applicable), the analysis of performance assessment information, a positive judgment value or reference interval data, stability measurements, to submit the original declaration registration data imported medical devices.
c. The registration procedure shall be implemented in accordance with NMPA, the Administrative Measures on Registration of Medical Devices, the Administrative Measures on Registration of IVD Reagents and the relevant provisions on electronic applications.
d. Where an application for registration is submitted and approved in accordance with the requirements of this announcement, the registration number of the relevant medical device of the imported product that has been approved for registration shall be indicated in the remarks column of the registration certificate.
3. Verification requirements of the registration system
The applicant shall ensure that the main production processes are included in the domestic production with no any changes, and provide self-examination report of the production quality management. Also shall include the comparison of domestic and foreign quality management system. NMPA conducts a comprehensive verification of domestic registration applicants, focusing on the quality and traceability of domestic and foreign quality management system, as well as whether changes in the system will generate new risk and cause changes in the registered items.
4. Post-market managements
When domestic applicant to conduct a medical devices production license shall apply for the Measures for supervision and Administration of Medical Device Production, strictly implement the main responsibility of quality safety, and strengthen the quality management of medical devices throughout their life cycle. Establish and improve the quality management system and ensure the effective operation according to the requirements of the Medical Device Production Quality Management Standard.
5. Other aspects
where an overseas registrant invested by a domestic enterprise of China produces a medical device of class II or Class III within the territory of China that has obtained the registration certificate of imported medical device, this announcement shall be followed, and the domestic enterprise of China investing in an overseas registrant shall apply for the registration of the product as the registration applicant.
This notice shall apply to the products in Hong Kong, Macao and Taiwan that have obtained medical device registration certificates
This announcement shall take effect as of the date of announcement.