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NMPA Announcement on Issuing of Two Registration Technical Review Guidelines Including the Guidelines for Technical Review of Clinical Evaluation of Ultrasound Diagnostic Imaging Equipment Based on Predicate Products
2021-01-18
The NMPA has organized to formulate 2 technical review guidelines for registration including the Guidelines for Technical Review of Clinical Evaluation of Ultrasound Diagnostic Imaging Equipment Based on Predicate Products.
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Medical Device Unique Identification Database Goes Online
2019-12-10
In the next step, NMPA will strengthen guidance and services for the application of unique identification data for medical devices,and open the unique identification database query and sharing services to the pilot units in March 2020 in accordance with the pilot work deployments.
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NMPA Issued the Guidelines for Conditional Approval for Marketing of Medical Devices
2019-12-20
NMPA organized the formulation of and released on December 20, 2019 the Guidelines for Conditional Approval for Marketing of Medical Devices.
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NMPA Announces New and Revised Catalogues of Medical Devices Exempted from Clinical Trials
2019-12-20
NMPA organized the formulation of new and revised catalogs (omitted) of medical devices and in vitro diagnostic reagents exempt from clinical trials, which have been announced on December 20, 2019.
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NMPA Issued the Guidelines for Conditional Approval for Marketing of Medical Devices
2019-12-20
NMPA organized the formulation of and released on December 20, 2019 the Guidelines for Conditional Approval for Marketing of Medical Devices.
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NMPA Issued the Guidelines for Nomenclature for Common Names of Medical Devices
2019-12-25
NMPA has organized the formulation of the Guidelines for Nomenclature for Common Names of Medical Devices, which has been issued on December 25, 2019.
