Measures for registration and filing of medical devices

The State Administration of market regulation officially announced the administrative measures for the registration and filing of medical devices and the in vitro diagnostic reagents, which will come into force on October 1, 2021. The measures clearly stipulate medical device registration, special registration procedures, change registration and renewal registration, medical device filing, working time limit, supervision and management and legal liability. Class I medical devices shall be subject to product filing management; Class II and class III medical devices shall be subject to product registration management. For the filing of domestic class I medical devices, the filing person shall submitRead More →

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