【 Q&A 】 Case Analysis of On-site Verification for the Registration of Imported to Domestic Medical Devices (Part One)

In recent years, the National Medical Products Administration has successively issued the "Announcement on Matters Concerning the Production of Imported Medical Devices by Enterprises within the Territory of China" (Announcement No. 104 of 2020) and the "Announcement on Further Adjusting and Optimizing Matters Concerning the Production of Imported Medical Devices by Enterprises within the Territory of China" (Announcement No. 30 of 2025). With the rapid development of China's medical device industry and the continuous optimization of the policy environment, the conversion of imported medical devices to domestic production has become a strategic choice for an increasing number of enterprises.

To help enterprises better understand policy requirements and reduce compliance risks, this article, through case analysis of active medical device products, explores the key concerns of on-site registration verification during the process of converting imports to domestic products, aiming to provide practical references for enterprises. In the future, we will continue to release case analyses around different product categories, delving deeply into the special requirements and common issues encountered during the localization process of various products. It is hoped that through the sharing of this series of articles, the quality management system capabilities of enterprises can be enhanced, the domestic transformation can be completed efficiently, and the high-quality development of the medical device industry can be jointly promoted.

[Case Summary] A certain active medical device enterprise, a wholly-owned subsidiary of a foreign enterprise established in China, submitted an application for the registration of medical device products in accordance with the requirements of the announcement. The declared products have the registration certificate for imported medical devices. The applicant for registration undertakes that the main raw materials and main production processes remain unchanged, and has provided a self-inspection report that the product's domestic production quality management system complies with China's "Good Manufacturing Practice for Medical Devices", as well as a comparison report of domestic and foreign quality management systems.

[Verification Approach] The Shanghai Medical Device Evaluation Center, in accordance with the requirements of the announcement and the verification work procedures for the registration quality management system, conducts verification on domestic registration applicants, with a focus on the substantive equivalence of the quality management system in the product design and development stages before and after the production change, to confirm whether the registration applicants meet the requirements of the "Good Manufacturing Practice for Medical Devices", with a focus on the following aspects:

1. Design and development: The substantive equivalence of the quality management system in this stage, and whether domestic regulations, mandatory standards, guideline documents, etc. have been identified; Whether the design and development output is complete; Whether design transformation was carried out and records of key processes, special procedures and trial production were retained; If there are minor changes in the design and development process, should risk assessment be conducted and control measures be taken?

2. Procurement: Whether the main raw materials have changed.

3. Production Management: Whether the main production processes have changed.

4. Quality control: Whether the product inspection procedures cover the mandatory standards and the performance indicators of the technical requirements of the registered or filed products.

[Verification Situation]

During the on-site verification, the following problems were found:

1. Design and Development: (1) Design input: The enterprise compared the quality management system of the country of origin with the requirements of China's production quality management norms, but did not supplement the difference provisions, and did not input domestic regulations and technical standards, etc. (2) Design output: The complete version information of the embedded software is not clearly defined; The instruction manual of the original imported product had an English description indicating "Contraindications: Contraindicated for pregnant women", but the Chinese instruction manual did not make it clear. (3) Design verification: The withstand voltage test was not conducted in accordance with GB 9706.1-2020. Only the CE certification test report of the original factory was referred to.

【 Analysis 】 : There are problems such as incomplete input, output defects, and insufficient design verification in the design and development stage, which lead to the product design not meeting the requirements of Chinese regulations and standards, causing compliance risks. It is suggested to supplement the input of domestic regulations and standards, and update the design output and verification documents.

2. Procurement: (1) All key raw material suppliers are overseas suppliers. The enterprise failed to provide the supplier audit report and the inspection reports of some key raw materials. (2) Spot-check the bill of materials. Materials A and B in the bill of materials that do not include the country of origin. (3) During a random inspection of a certain key component, the enterprise failed to provide the factory inspection records from its overseas original factory, making it impossible to confirm whether the key parameters met the requirements.

【 Analysis 】 : There are problems such as non-standard supplier management, raw material changes, and incomplete traceability of key components in the procurement process. Moreover, risk assessment and control measures have not been adopted to ensure the consistency of major raw materials. It is suggested to improve the supplier audit procedure, provide inspection records of key raw materials and change assessment.

3. Quality Control: The product inspection records can be found, which do not include the main performance indicators such as output power, system accuracy, and repeatability as stipulated in the product technical requirements.

【 Analysis 】 : The product inspection records do not cover the technical requirements of the product. It is suggested that the inspection procedures be revised to ensure that the technical requirements of the product are covered or to provide a scientific basis for exemption from inspection.

[Case Summary] Through the above case analysis, it is suggested that enterprises transitioning from overseas to domestic further enhance their quality management systems, strengthen their understanding of domestic regulations and standards, change the original inertial thinking of medical device import registration agents, increase their awareness of production compliance, and reduce the regulatory and quality risks caused by misunderstandings of regulations and standards during the process of transitioning from imported to domestic medical devices. Strengthen the differentiated management of imported products to domestic ones and avoid "copying domestic production". In light of the actual domestic production situation, improve verification scenarios such as personnel training, equipment validation, and process validation to facilitate the smooth progress of the localization process.

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Source: Shanghai Qishen