The guideline introduces changes to the rules governing foreign-invested enterprises (FIEs) involved in producing imported medical devices domestically in China. This draft is an update to the initial regulation released in 2020 (Decree 104). Here’s a summary highlighting the main changes and additions.
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Expanded Scope of Application
The original 2020 regulation allowed foreign-invested enterprises to produce imported medical devices domestically if they were established by the foreign medical device registrant. The updated regulation now broadens this scope. In addition to foreign-invested enterprises established directly by the foreign device registrant, the updated regulation includes enterprises with the same “actual controller” as the registrant. This means that the FIE can produce imported medical devices domestically if the FIE is either set up by the original registrant or shares a common actual controlling entity with the registrant. This change allows more entities to qualify for domestic production, potentially expanding local manufacturing options for international medical device companies.
Enhanced Requirements for Registration
The updated regulation introduces additional requirements for the registration application process to ensure more transparency and oversight:
- Proof of Common Actual Control: If the applicant and the imported device registrant have the same actual controller, they must submit documentation that explains and supports this relationship. This can include a description of their equity relationship, as well as recent business reports (including information on the actual controller) of the applicant. These documents must be uploaded or disclosed as required by authorities and kept on file by drug regulatory agencies.
- Authorization from the Registrant: The applicant must also submit an authorization letter from the imported device registrant, explicitly agreeing to allow the applicant to use the registrant’s original application materials for local registration and production in China. This authorization must be notarized in the registrant’s home country, adding a layer of verification and protection for the intellectual property and proprietary information of the original registrant.
These additional documentation requirements strengthen regulatory oversight, ensuring that only appropriately linked entities can use original registration information and that their relationship with the registrant is clearly defined and authorized.
Registration System Verification Requirements
To maintain high standards of quality and safety, the updated regulation adds new requirements for verifying the quality management systems (QMS) of domestic production facilities:
- Commitment on Materials and Processes: Applicants must confirm that primary materials and production processes will not change during local manufacturing. They must provide a self-assessment report showing compliance with China’s Good Manufacturing Practices for medical devices and include a comparative report of the domestic and international quality management systems.
- Quality Management System Consistency: Regulatory authorities will conduct a thorough review of the applicant’s QMS, focusing on ensuring that the design and development processes of the imported and domestically produced products are substantively identical. If there are any differences in the QMS between the imported product and the locally manufactured product, the applicant must provide detailed explanations, commit that these differences will not lead to changes in the registered matters, and conduct a risk analysis that identifies key risk points and control measures to ensure product safety, efficacy, and quality.
These measures are intended to prevent any quality disparities between the imported and domestically produced versions of a product, thereby protecting end users in China.
Special Consideration for Innovative Devices
The new regulation provides preferential treatment for innovative imported medical devices that will be produced domestically. If an imported medical device is classified as innovative and meets the requirements of the Announcement, its registration and production permits will be processed with priority. This change aligns with China’s goals of fostering innovation within its domestic market by encouraging the local production of advanced medical technology.
Additional Provisions
The updated regulation includes further stipulations to clarify the registration process for specific cases:
- Domestic Investment in Foreign Registrants: If a Chinese enterprise has invested in a foreign registrant that wishes to produce approved imported medical devices domestically, the investment entity or another local company under the same actual control can apply for the registration of the product. This provision facilitates the process for Chinese companies that have invested in foreign medical device companies and wish to bring production back to China.
- Subsequent Registration Matters: For products that have obtained approval, any changes to registration or renewals will be handled in accordance with the “Measures for the Administration of Medical Device Registration and Recordation” and the “Measures for the Administration of In Vitro Diagnostic Reagent Registration and Recordation.”
These proposed changes reflect China’s intent to control the quality and consistency of domestically produced medical devices, support innovation, and encourage foreign and local companies to expand their manufacturing capabilities within China. The documentation and QMS requirements reinforce regulatory oversight, while the broader applicability and priority processing for innovative devices may attract more international medical device companies to localize their production, ultimately fostering growth in China’s healthcare manufacturing sector.
