Administrative Measures on the Registration and Record-filing of Medical Devices
ISSUING AUTHORITY:
State Administration for Market Regulation
DATE OF ISSUANCE:
August 26, 2021
EFFECTIVE DATE:
October 1, 2021
On August 26, 2021, the State Administration for Market Regulation (SAMR) promulgated the Administrative Measures on the Registration and Record-filing of Medical Devices (the “Administrative Measures”), which took effect on October 1, 2021.
The Administrative Measures, which is a supporting document of the Regulation on the Supervision and Administration of Medical Devices, perfects and refines the registration and record-filing management system of medical devices. It summarizes the achievements of medical device approval reforms in recent years, including but not limited to incorporating a new chapter of Special Registration Procedures, which covers sections of Registration Procedures for Innovation Products, Procedures for Priority Registration and Procedures for Emergency Registration.
With regard to the Procedures for Emergency Registration of medical devices, the Administrative Measures makes it clear that the National Medical Products Administration (NMPA) may implement emergency registration for medical devices in accordance with the law in the following situations: (i) where certain medical devices are needed for public health emergencies and there is no similar product that has been marketed within the territory of PRC or (ii) where similar products have been marketed within the territory of PRC but the supply of such products cannot meet the needs for responding to public health emergencies.
By implementing the Special Registration Procedures, the Administrative Measures shortens the product launch date, stimulate innovation in and high-quality development of the medical device industry.
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