NMPA: Optimizations for the Domestic Production of Imported Medical Device Products in China

In September 2020, the Announcement on Matters Concerning the Domestic Production of Imported Medical Devices by Enterprises within China (Announcement No. 104 of 2020, hereinafter referred to as the Announcement) was issued and implemented. Certain requirements of the Announcement are hereby further adjusted and optimized as follows:

I. Scope of Application

The foreign-invested enterprises referred to in the Announcement may be enterprises established by the registrant of the imported medical device or enterprises under the same de facto controller as the registrant of the imported medical device. Specifically, the Announcement applies to matters concerning the self-production of Class II or Class III imported medical devices with valid import medical device registration certificates within the People's Republic of China by foreign-invested enterprises established by the registrant of the imported medical device or under the same de facto controller as the registrant.

The de facto controller shall comply with the relevant definitions and provisions of the Company Law of the People's Republic of China, meaning the de facto controller refers to a person who, through investment relationships, agreements, or other arrangements, is able to actually control the behavior of the company.

II. Registration Application Requirements

1. The registration applicant shall submit registration application materials in accordance with the format and catalog requirements specified in the Announcement on the Publication of Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (No. 121 of 2021) and the Announcement on the Publication of Requirements for In Vitro Diagnostic Reagent Registration Application Materials and the Format of Approval Documents (No. 122 of 2021).

   Among these, the product overview materials, non-clinical materials (excluding the safety and performance essential principles checklist, product technical requirements, and inspection reports), and clinical evaluation materials may utilize the original registration application materials of the imported medical device. The product technical requirements and inspection reports shall demonstrate that the product complies with applicable mandatory standards.

2. If the registration applicant and the registrant of the imported medical device are under the same de facto controller, the applicant shall provide a statement and supporting documents proving that both parties are under the same de facto controller. The statement may include an explanation of the equity relationship between the two parties, and the supporting documents shall include reports containing information on the de facto controller, such as the most recent Enterprise Annual Report of the registration applicant, which has been uploaded or disclosed as required by the competent authority. The relevant statements and supporting documents shall be archived by the medical device regulatory authority for future reference.

3. The registration applicant shall submit an authorization letter issued by the registrant of the imported medical device explicitly consenting to the registration applicant's use of the original registration application materials of the imported medical device for domestic registration application and product production. The authorization letter shall be notarized by a notary institution in the locality of the registrant of the imported medical device.

III. Requirements for Registration System Verification

The registration applicant shall承诺 (commit) that there will be no changes to the key raw materials and key production processes, and shall provide a self-inspection report confirming that the domestic production quality management system complies with China's Medical Device Production Quality Management规范 (Specifications) and a comparative report on the quality management systems domestically and internationally.

The medical device regulatory authority shall conduct verification of the domestic registration applicant in accordance with the procedures for medical device registration quality management system verification, with particular focus on the substantial equivalence of the quality management systems in the product design and development process domestically and internationally.

If there are differences between the quality management systems of the domestically proposed registered product and the imported medical device, the registration applicant shall provide a detailed explanation,commit that such differences will not lead to changes in registration matters, and conduct risk analysis to identify key risk points and control measures, ensuring the product is safe, effective, and of controllable quality.

IV. Other Aspects

1. For imported innovative medical devices produced domestically in accordance with the requirements of the Announcement, matters such as registration and production permits shall be prioritized.

2. For the domestic production of Class II or Class III medical devices with valid import medical device registration certificates by overseas registrants invested in by domestic Chinese enterprises, the domestic Chinese enterprise investing in the overseas registrant or another domestic enterprise under the same de facto controller as the domestic enterprise shall act as the registration applicant to apply for product registration and self-production.

3. Subsequent matters such as changes to registration) and registration renewal for approved registered products shall be handled in accordance with the Measures for the Administration of Medical Device Registration and Filing and the Measures for the Administration of the Registration and Filing of In Vitro Diagnostic Reagents.