On 25 September 2020, the NMPA promulgated the Announcement on Matters Concerning the Production of Imported Medical Device Products by Enterprises within the People’s Republic of China (the “PRC”) with effect from the date of promulgation (the “Announcement”). Before the implementation of the Announcement, a foreign enterprise which already holds a registration certificate for Class II or Class III imported medical devices or in vitro diagnostic (“IVD”) products (“Foreign Registrant”) should manufacture the imported medical devices outside the PRC according to the requirements in the registration documents, including the place of manufacturing.
The Announcement provides an accelerated pathway for the localization of imported medical devices and IVD products in the PRC. According to the Announcement, a Foreign Registrant is permitted to let its subsidiary established in the PRC (“Domestic Registrant”) register the same product as a domestic product and hold the relevant registration certificate.
- 1) A foreign-invested enterprise established by the registrant of imported medical devices in China, as a registered applicant, should submit an application for registration of domestic medical devices to NMPA. In principle, the contents of the application for registration should be consistent with the relevant matters set out in the corresponding registration certificate for imported medical devices and their annexes, except for the name, domicile and production address of the registrant.
- 2) The registered applicants should submit the registration declaration information in accordance with the requirements of Medical Device Registration Declaration Information requirements and Announcement of the Approval Document Format (NMPA No. 43 of 2014). Medical device review data, research data, clinical evaluation data and product risk analysis data can be submitted to the original registration and declaration of imported medical devices. The relevance and support of the two should be ensured.
- 3) The registration and declaration procedure should be carried out in accordance with the Measures for Administration of Medical Device Registration and relevant provisions for the electronic declaration of medical devices.
- 4) The medical device registration number of the relevant approved imported product should be stated in the notes to the registration certificate.
Registration system verification requirements
The registered applicant should ensure that the main production process of products is produced in China and undertake that the main raw materials and production processes will not change, and provide a self-examination report on the quality management system of the production in China in accordance with Medical device manufacturing quality management specifications and a comparative report on the quality management system at or outside China.
Post-market supervision requirements
Domestic registrant should handle medical device production licenses in accordance with the Measures for Supervision and Administration of Medical Device Production，to establish and improve the quality management system and ensure effective operation in accordance with Medical device manufacturing quality management specifications.
Announcement of NMPA on matters related to the production of imported medical device products by enterprises in China (No. 104, 2020)