MEDTECH NEWS

The General Office of the National Medical Products Administration (NMPA) of China has released a draft announcement titled "Announcement on Further Clarifying Matters Related to the Production of Imported Medical Device Products by Enterprises Within China (Draft for Comments)" on November 4, 2024. The NMPA is now openly soliciting public opinions on this draft to deepen medical device regulatory reforms and promote high-level industrial openness, aiming to better meet the public's needs for medical devices.

The announcement applies to foreign-invested enterprises that are either established by imported medical device registrants or share the same actual controller with the registrants. Specifically, it concerns matters related to these enterprises producing Class II and Class III medical devices—already holding import medical device registration certificates—within China.

The term "actual controller" should align with the relevant definitions and provisions outlined in the "Company Law of the People's Republic of China."

Applicants must submit registration materials in the format and directory specified by the NMPA's Announcements No. 121 and No. 122 of 2021. Materials such as the product's summary, non-clinical data (excluding the safety and performance essential principles checklist, product technical requirements, and inspection reports), and clinical evaluation data can utilize the original registration materials of the imported medical device. Product technical requirements and inspection reports must demonstrate compliance with applicable mandatory standards.

If the applicant shares the same actual controller with the imported medical device registrant, they must provide a statement and supporting documents explaining this relationship. Documentation may include explanations of equity relationships and the applicant's most recent "Enterprise Annual Report" (including information about the actual controller), which should have been uploaded or disclosed as required by the competent authorities. These explanations and documents will be archived by the drug regulatory department for future reference.

Applicants must submit an authorization letter from the imported medical device registrant, clearly agreeing to allow the applicant to use the original registration materials for domestic registration and production. The authorization letter must be a notarized document issued by a notary institution in the registrant's location.

Applicants must commit to not altering the main raw materials and primary production processes. They should provide a self-inspection report demonstrating that their domestic production quality management system complies with China's "Medical Device Production Quality Management Specifications." A comparative report between domestic and overseas quality management systems is also required.

The drug regulatory department will conduct comprehensive inspections of the applicant's quality management system, focusing on the substantive equivalence between domestic and foreign systems, especially in product design and development. If differences exist between the domestic and imported quality management systems, applicants must detail these discrepancies, ensure they will not trigger changes in registration particulars, and perform risk analyses to clarify major risk points and control measures, ensuring product safety, effectiveness, and quality control.

Imported innovative medical devices transitioning to domestic production under this announcement will receive priority in registration and production licensing processes.

If a Chinese domestic enterprise invests in an overseas registrant and intends to produce Class II and Class III medical devices (already holding import registration certificates) within China, the domestic enterprise or another domestic enterprise sharing the same actual controller should apply as the registration applicant.

Approved products' subsequent matters, such as registration changes and renewals, should be handled in accordance with the "Measures for the Administration of Medical Device Registration and Filing" and the "Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing."