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NMPA Notice on Issuing the Guidance for Technical Review of Clinical Evaluation of Equivalent Devices of Medical Magnetic Resonance Imaging Systems (Revision 2020)
2021-02-01
The NMPA organized to formulate the Guidance (Revision 2020) for Technical Review of Clinical Evaluation of Equivalent Devices of Medical Magnetic Resonance Imaging Systems which was issued on January 27, 2021.
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NMPA Announcement on Issuing Three Guidelines for Technical Review of the Registration Including that of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents
2021-01-19
NMPA has organized the formulation of and released on January 18, 2021 Three Guidelines for Technical Review of the Registration including that of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents.
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NMPA Announcement on Issuing the Catalogue of Medical Devices Exempt from Clinical Trials (Revised Second Batch)
2021-01-19
NMPA issued the Announcement on the Issuance of the New and Revised Catalogues of Medical Devices Exempt from Clinical Trials, and published the first batch of New and Revised Catalogues of Medical Devices (and in vitro diagnostic reagents) Exempt from Clinical Trials.
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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.
