Notice on the Guidelines for the Verification of Medical Device Registration Quality Management System Rreleased!

In September 29, 2022, NMPA issued the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (No. 19 in 2020). The text of the notice is as follows:

In order to do a good job in the verification of the registration quality management system under the medical device registrar system and improve the quality of the verification of the medical device registration quality management system, in accordance with the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council), the Administrative Measures for the Registration and Filing of Medical Devices (Order No. 47 of the General Administration of Market Supervision), the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48 of the General Administration of Market Supervision) ，According to the requirements of the Measures for the Supervision and Administration of the Production of Medical Devices (Order No. 53 of the State Administration of Market Supervision), the State Drug Administration has organized the revision of the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (see the annex), which will be implemented as of the date of promulgation. The Notice on Issuing the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (No. 19 in 2020) issued by the State Drug Administration shall be repealed at the same time.

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