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The recent adjustment to the “Announcement of the State Drug Administration on Matters Related to the Production of Imported Medical Devices by Enterprises in China” (No.104 of 2020) reinforces China’s commitment to deepening medical device supervision while promoting innovation and investment in the industry.
Key Adjustment and Scope of Application
The latest regulatory updates clarify that foreign-invested enterprises eligible under the announcement must either be established by the registrant of imported medical devices or share the same actual holders. This applies to the self-production of Class II and III medical devices registered as imported products in China.
Registration and Application Requirements
Foreign-invested enterprises seeking to register and produce imported medical devices domestically must adhere to specific application requirements:
Registration Materials: Submissions must follow the guidelines outlined in previous National Medical Products Administration (NMPA) announcements No. 121 (2021) and No. 122 (2021).
Use of Original Registration Data: Applicants can utilize existing registration data from the imported medical device, including product summary, non-clinical, and clinical evaluation information, except for product technical requirements and inspection reports, which must align with China’s mandatory standards.
Proof of Common Control: If the applicant and the imported device registrant share the same actual controller, they must submit official documentation verifying this relationship, such as equity relationship statements and annual enterprise reports.
Authorization from the Registrant: A notarized authorization letter from the original device registrant is required, granting permission for the use of original registration materials for domestic production and registration.
Verification of Registration System Compliance
A key aspect of the updated requirements is ensuring that domestic production adheres to China’s “Medical Device Production Quality Management Standards”.
Applicants are required to:
Guarantee that key raw materials and manufacturing processes remain unchanged
Provide self-inspection and comparative reports demonstrating compliance with both domestic and international quality management systems
Address any differences in quality management systems and conduct risk analyses to confirm product safety and efficacy
Undergo verification procedures by the drug regulatory authorities, which focus on maintaining consistency in design and development quality
Additional Provisions for Imported Innovative Medical Devices
To encourage innovation, the updated announcement prioritizes the registration and licensing processes for imported innovative medical devices that are manufactured in China. Moreover:
If an overseas registrant, backed by a domestic enterprise, produces Class II or III devices in China, the domestic enterprise or another entity under the same actual controller must apply for registration
Subsequent registration changes, renewals, and other administrative processes must comply with existing measures governing medical device and in-vitro diagnostic reagent registration
These regulatory enhancements mark a significant step toward aligning China’s medical device industry with global best practices while facilitating investment from foreign enterprises. By refining the framework for the domestic production of imported medical devices, the State Drug Administration aims to strengthen regulatory oversight, enhance efficiency, and promote the sustainable growth of China’s healthcare industry.
For further details, stakeholders are encouraged to review the full announcement issued by the State Drug Administration here or contact us at info@arqon.com
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