Latest! Another Important New Regulation for Medical Devices Released (With Official Interpretation)

Announcement on Further Adjustments and Optimization of Matters Concerning the Production of Imported Medical Device Products by Enterprises within China

In September 2020, the "Announcement of the National Medical Products Administration on the Production of Imported Medical Devices by Enterprises within China" (No. 104 of 2020, hereinafter referred to as the "Announcement") was released and implemented. In order to thoroughly implement the decisions and plans of the CPC Central Committee and the State Council regarding the promotion of high-level opening up, and to fully implement the requirements of the "Opinions of the General Office of the State Council on Deepening the Reform of Drug and Medical Device Supervision and Promoting High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53), and to continuously deepen the reform of medical device supervision and promote the high-quality development of the medical device industry, the following further adjustments and optimizations are made to some of the requirements of the "Announcement":

I. Scope of Application

II. Registration and Filing Requirements

(1) The registration applicant shall submit the registration application documents in the format, catalog, etc., as required by the "Announcement of the National Medical Products Administration on the Requirements for Medical Device Registration Application Documents and the Format of Approval Certificates" (No. 121, 2021) and the "Announcement of the National Medical Products Administration on the Requirements for In Vitro Diagnostic Reagent Registration Application Documents and the Format of Approval Certificates" (No. 122, 2021).

Among these, the product overview, non-clinical information (excluding the safety and performance basic principles list, product technical requirements, and test reports), and clinical evaluation information can use the original registration documents of imported medical devices. The product technical requirements and test reports should demonstrate that the product meets the applicable mandatory standard requirements.

(2) If the registration applicant and the registrant of imported medical devices have the same actual controller, a statement and supporting documents showing that both parties have the same actual controller should be provided. The statement may include an explanation of the equity relationship between the two parties, etc. The supporting documents should include the most recent "Annual Report of the Enterprise" of the registration applicant, or other reports containing information about the actual controller, which have been uploaded or disclosed as required by the competent authority. The relevant statements and supporting documents shall be kept on file by the drug regulatory department for future reference.

(3) The registration applicant shall submit an authorization letter issued by the registrant of the imported medical device, clearly agreeing to allow the registration applicant to use the original registration submission materials of the imported medical device for domestic registration application and product manufacturing. The authorization letter shall be notarized by a notary institution in the location of the registrant of the imported medical device.

III. Registration System Verification Requirements

The registration applicant shall commit to not changing the main raw materials and primary production processes, and provide a self-inspection report demonstrating that the product's domestic production quality management system complies with our country's "Medical Device Production Quality Management Standards," as well as a comparison report of the quality management systems both domestically and internationally.

The pharmaceutical regulatory authority conducts inspections on domestic registration applicants according to the medical device registration quality management system inspection procedures, while focusing on the substantial equivalence of the quality management systems for product design and development both domestically and internationally.

For domestic products intended for registration and imported medical devices where there are differences in the quality management system, the registration applicant should provide a detailed explanation, commit that such differences will not cause changes to the registration matters, and at the same time, conduct a risk analysis, identifying the main risk points and control measures, to ensure the product is safe, effective, and of controllable quality.

IV. Other Aspects

(1) For imported innovative medical device products that are produced in China according to the requirements of the Announcement, corresponding registration, production permits, and other matters will be prioritized.

(2) For Class II and Class III medical devices that have already obtained import medical device registration certificates and are produced domestically by overseas registrants invested in by enterprises within China, the registration applicant shall be the enterprise within China that has invested in the overseas registrant or another domestic enterprise under the same actual controller. This applicant shall apply for product registration and produce the product themselves.

(3) For products that have been approved for registration, subsequent matters such as change registration and renewal registration shall be handled in accordance with the provisions of the Medical Device Registration and Filing Management Measures and the In Vitro Diagnostic Reagent Registration and Filing Management Measures.

Hereby announced.

Interpretation of the Announcement on Further Adjustments and Optimization of Matters Concerning the Production of Imported Medical Device Products by Enterprises within China

"Notice on Further Adjustment and Optimization of the Production of Imported Medical Devices by Enterprises within China" (No. 30, 2025) was issued on March 18, 2025. It came into effect from the date of issuance (hereinafter referred to as "the Notice"). The background, main principles, and key issues of the adjustments and optimizations made in the Notice are explained as follows:

I. Background

In 2020, the National Medical Products Administration issued the "Announcement on Matters Concerning the Production of Imported Medical Devices by Enterprises within China" (No. 104, 2020) (hereinafter referred to as Announcement No. 104), which optimized the requirements for registration application materials, accelerated the market entry process for relevant products, and further enriched the domestic supply of medical devices. On December 30, 2024, the General Office of the State Council issued the "Opinions on Deepening the Reform of Drug and Medical Device Supervision and Promoting High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53), explicitly proposing to "optimize the evaluation and approval process for transferring drugs and medical devices already marketed overseas to be produced domestically, and support foreign-invested enterprises in introducing original research drugs and high-end medical equipment for domestic production." To implement these requirements, based on in-depth research and extensive solicitation of opinions from all sides, the National Medical Products Administration has drafted this "Announcement."

II. Main Principles

In response to the industry's request for further optimization of relevant measures during the implementation of Announcement No. 104, the Announcement adheres to a problem-oriented approach, integrates the current regulatory requirements for medical device registration, and is based on the principle of scientific regulation. It further adjusts the scope of application, adjusts and optimizes the registration application requirements, optimizes the requirements for registration system verification, and increases support for innovative products produced domestically. The contents of Announcement No. 104 not mentioned in this Announcement remain valid.

(1) Adjust the scope of application. Change "foreign-invested enterprise" in Announcement No. 104 from being established by the registrant of imported medical devices, to "an enterprise established by the registrant of imported medical devices, or an enterprise with the same actual controller as the registrant of imported medical devices," and clarify that the actual controller should conform to the relevant definitions and regulations under the Company Law of the People's Republic of China. That is, the actual controller refers to a person who can actually control the actions of the company through investment relationships, agreements, or other arrangements.

(2) Adjust and optimize the registration data submission requirements.

The first is to clarify that the registration applicant should submit the registration application materials according to the format and catalog required by the current application material requirements, that is, in accordance with the format, catalog, etc., as required in the Announcement of the National Medical Products Administration on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents (No. 121 of 2021) and the Announcement of the National Medical Products Administration on Publishing the Requirements for In Vitro Diagnostic Reagent Registration Application Materials and the Format of Approval Documents (No. 122 of 2021).

Overview of the product, non-clinical data (excluding the list of safety and performance principles, product technical requirements, and test reports), and clinical evaluation data can use the original registration documents of imported medical devices. Product technical requirements and test reports should demonstrate that the product meets the applicable mandatory standards.

Second, it is stipulated that if the registration applicant and the registrant of imported medical devices have the same actual controller, the registration applicant should provide an explanation and supporting documents showing that both parties have the same actual controller. The explanatory documents may include a description of the equity relationship between the two parties, etc. The supporting documents should include the most recent "Annual Enterprise Report" of the registration applicant or other reports containing information about the actual controller, which have been uploaded or disclosed as required by the competent authority. The relevant explanations and supporting documents shall be filed by the drug regulatory department for future reference.

The third point is to clarify that the registration applicant should submit an authorization letter issued by the overseas medical device registrant, clearly agreeing to the registration applicant's use of the original registration materials of the imported medical device for domestic registration application and product manufacturing. The authorization letter should be notarized by a notary institution in the location of the overseas medical device registrant.

(3) Optimization of the registration system audit requirements. It is clearly stipulated that the drug regulatory authorities shall conduct audits on domestic registration applicants in accordance with the work procedures for the quality management system audit of medical device registration, while paying special attention to the substantive equivalence of the quality management systems at home and abroad during the product design and development phase.

For domestic products intended for registration and imported medical devices where there are differences in the quality management system, the registration applicant should provide a detailed explanation, commit that such differences will not cause changes to the registration matters, and at the same time conduct a risk analysis, identifying the main risk points and control measures to ensure the safety, efficacy, and quality controllability of the product.