On March 18, 2025, the National Medical Products Administration (NMPA) issued the Announcement on Further Adjusting and Optimizing the Production of Imported Medical Device Products in Enterprises in China (No. 30 [2025]) (Announcement No. 30). Building on the goal of strengthening the domestic medical device industry and following the previous announcement in 2020, Announcement No. 30 aims to do more than just accelerate the localization of imported medical devices manufacturing.
Background and links
Announcement No. 30 serves as an upgrade to the previous policy (NMPA Announcement No. 104 [2020] – Announcement on Matters Related to the Production of Imported Medical Device Products in Enterprises in China), further advancing the localization of imported medical devices in China.
Original announcement> Announcement of the State Food and Drug Administration on Further Adjusting and Optimizing the Production of Imported Medical Device Products in Enterprises in China (No. 30 [2025])
Announcement Interpretation from NMPA> Interpretation of the Announcement on Further Adjusting and Optimizing the Production of Imported Medical Device Products in Enterprises in China
Abstract
Announcement No. 30 promotes deeper localisation of imported medical device by leveraging the interaction between market demand and foreign capital and knowhow. Collaborating with local manufacturers will drive improvements in domestic manufacturing practices. Meanwhile, imported device companies need to integrate China’s compulsory technical standards into their product design and development assesment processes. More importantly, they must act swiftly to seize opportunities and leverage their capital and knowhow to capture greater market share. Key information from Announcement No. 30. summarised as bellow:
1) Expanding entry possibilities for “Made in China”
According to Announcement No. 30, not only foreign-invested entities, but also entities under the same actual controller as the imported medical device registrant are also permitted to engage in manufacturing. This offers more flexibility for entering the local manufacturing and join the public hospitals’ purchase with domestic manufactured devices.
2) Adjusting the registration documentations
Announcement No. 30 reaffirms the applicability of foreign technical document, but strongly emphasis on the compliance to the compulsory standards in China regarding Product Technical Requirements (PTR) and other test reports. Collaboration with local laboratories will continue to grow. Meanwhile, the understanding of compulsory standards requires greater attention. Additionally, extra documents are required for entities under the same actual controller.
3) Change in the registration inspection/audit setting
Greater emphasis is placed on the substantial equivalence between domestic and overseas quality management systems, especially concerning product development and design stages.
4) Encouraging the localisation of manufacturing innovative products
The new policy priorities imported innovation, granting priority registration and production licensing to products in cutting-edge, significantly shortening their time for market authorization.
Highlights and Thoughts
Key information from Announcement No. 30. summarised as bellow:
- Expanding entry possibilities for “Made in China”
| Announcement no. 30, 2025 | Announcement no. 104, 2020 |
| The “foreign-invested enterprises” mentioned in the Announcement may refer to enterprises established by the imported medical device registrant or those under the same actual controller as the imported medical device registrant.The controlling entity shall comply with the definition Company Law of China, which means it can control the company through investment, agreement or other means. | only allowed foreign-invested enterprises established by the imported medical device registrants to run the domestic manufacturing in China. |
| Thoughts: This change provides a more flexible entrance for the localization of imported medical devices in China, enabling multinational companies to set up local manufacturing more efficiently. Combined with the purchasing policy favoring domestic devices in public hospital tenders, collaboration with local manufacturing is expected to grow. | |
- Adjusting the registration documentations
| Announcement no. 30, 2025 | Announcement no. 104, 2020 |
| Allows registration applicants to use the original application documents of imported devices, including general product description, non-clinical and clinical evaluation documents for registration application. The non-clinical documents exclude the GSPR list and the PTR test report. PTR and the relevant test reports shall comply with China´s compulsory standards. | The general product description, research data, clinical evaluation data, and product risk analysis data of medical device products, as well as the general description of in vitro diagnostic reagent products, research data on key raw materials (if applicable), research data on key production processes and reaction systems (if applicable), analytical performance evaluation data, data on the determination of positive judgment values or reference intervals, stability study data, clinical evaluation data, and product risk analysis data, may be submitted using the original registration application materials of the imported medical device. The imported registrant and the domestic registration applicant must ensure the relevance and supporting nature of the above materials in relation to the current registration application. |
| The proof requirements have been clarified for cases where the registration applicant and the imported medical device registrant share the same actual controller. Documents such as a statement of their shareholding relationship and supporting materials that reflect the actual controller’s information, including the Enterprise Annual Report and other necessary documentation shall be disclosed to the NMPA. | No relevant requirements |
| The registration applicant shall submit a power of attorney (POA) issued by the imported medical device applicant, authorizing the use the original registration application materials. The POA shall be notarized by a notary institution in the jurisdiction where the imported device´s company is located. | No relevant requirements |
| Thoughts: It is an illusion that Announcement no. 30 simplifies the registration process. The practices outlined in the announcement are already being implemented under the announcement 104. It does, however, place a strong emphasis on compliance with mandatory technical standards. Local PTR testing (product technical requirements), along with other compulsory tests such as IEC and EMC tests for active devices, are essential. Multinational companies need to carefully address the difference and gaps between standards in the R&D process. Collaboration with local laboratories will continue to grow. Meanwhile, the understanding of compulsory standards requires greater attention. Additional administrative documents and notarization process need to be considered when the imported medical device registrant and the registration applicant share the same controller, such as the POA, the statement of relationship, and the enterprise annual report. | |
- Change in the registration inspection setting
| Announcement no. 30, 2025 | Announcement no. 104, 2020 |
| The registration applicant shall commit that the main raw material and key production processes will remain unchanged. The registration applicant shall also provide 1) a self-inspection report showing the compliance with GMP and 2) a comparative report on the domestic and overseas quality management systems. The NMPA conducts inspections on the domestic registration applicants with focus on the substantive equivalence of the quality management system between domestic and overseas product´s design and development stages. If there are differences between the quality management system of the domestically registered product and that of the imported medical device, the registration applicant must provide a detailed explanation and commit that these differences will not lead to changes in the registration items. Additionally, they must conduct a thorough risk analysis, identify key risk points, and define control measures to ensure the product’s safety, effectiveness, and quality control. | The registration applicant shall ensure that the main production process of the product is conducted domestically and commit that the primary raw materials and production process will not change. They shall provide 1) a self-inspection report demonstrating that the domestic production quality management system complies with China’s GMP 2) a comparative report on the equivalence of domestic and foreign quality management systems. The NMPA, following the procedures for medical device registration quality management system verification, will conduct a comprehensive inspection of domestic registration applicants. The focus will be on the equivalence and traceability of domestic and foreign quality management systems, as well as whether changes in the production process lead to system modifications that introduce new risks and require amendments to registration items. |
| Thoughts: Announcement No. 30 highlights the substantive equivalence between domestic and overseas quality management systems, with a particular focus on the product design and development stages. In conjunction with the requirement to comply with national compulsory standards, this underlines the need for Chinese standards to be integrated into the product design and development assessment process. Yet, substantive equivalence does not imply that things are identical. Reasonable differences with sufficient justification will be accepted. The differences and gaps must be taken into the risk analysis documents. | |
- Encouraging the localization of manufacturing innovative products
| Announcement no. 30, 2025 | Announcement no. 104, 2020 |
| The new policy priorities imported innovation, granting priority registration and production licensing to products in cutting-edge, significantly shortening their time for market authorization. | No input on innovative products |
| Thoughts: Innovative products are expected to enter China faster, narrowing the technological gap between domestic and international markets. Implementation of this change needs to be observed. | |
Conclusion
Announcement No. 30 promotes deeper localisation of imported medical device by leveraging the interaction between market demand and foreign capital and knowhow. Collaborating with local manufacturers will drive improvements in domestic manufacturing practices. Meanwhile, imported device companies need to keep engaging the local laboratories and integrate China’s compulsory technical standards into their product design and development assessment processes. More importantly, they must act swiftly to seize opportunities and leverage their expertise to capture greater market share.