NMPA published the final notice “Issues regarding Approved Imported Medical Devices Manufactured by Chinese Domestic Enterprises” on September 25, 2020. The draft version was released on March 5, 2020.
The NMPA announcement encourages foreign manufacturers to localize their approved devices’ production in China with providing an expedited approval pathway for their devices made in China. The pathway becomes available on the premise that the main raw materials and production processes do not change, and the quality management system is consistent with previous one. If an overseas company intends to manufacture their approved device in China, their Chinese entity, who act as the domestic license holder, will be able to re-use some of regulatory deliverables that were submitted for obtaining the imported license. This change accelerates the registration process as the localized device does not need to go through the same time-consuming and repetitive process during the registration of the same products as domestic products.
Many deliverables such as the research summary or clinical evaluation report will be allowed to be reused; new Product Technical Requirement and new Product Registration Testing Report are required.
The advantage of localizing device production is that devices will become more competitive in the market as hospitals give preference to Chinese domestic products during public tenders. One prerequisite for utilizing this guideline is that devices to be transferred to China must have already received approval as an imported device. Under this new pathway, the simplified deliverable list and the re-evaluation process will greatly facilitate the localization of imported medical devices.
The purpose of the certificate transfer is to optimize the registration application materials for the manufacturing of imported medical device in domestic enterprises within the existing legal framework. Products should be produced by foreign-invested enterprises established in China by the registrant of imported medical devices. They are not within the scope of the pilot program of the medical device registrant system and cannot be commissioned for manufacturing.
The certificate transfer applies to products whose original imported registration certificate has not expired or withdrew.
The announcement clarifies that if a registration application is approved and transferred, the remarks column of the registration certificate should include the registration number of the original imported product, so that the regulatory authorities at all levels can check for identification and traceability. The domestic certificate and the original imported device certificate are independent of each other and managed separately.
For the English version of the “Issues regarding Approved Imported Medical Devices Manufactured by Chinese Domestic Enterprises” or any documents mentioned above, please email info@ChinaMedDevice.com.
NMPA produced the “Medical Device/In Vitro Diagnostic Reagent Registration and Application Data Requirements”, to guide imported devices to be manufactured in China. For an English copy please email info@ChinaMedDevice.com.