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NMPA Announcement on Issuing 5 Technical Review Guidances for Registration
2021-04-15
To strengthen the supervision and guidance of medical device registration and further improve the quality of registration review, NMPA has organized to formulate the following guidances, which were issued on April 7.
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National Annual Report for Medical Device Adverse Event Monitoring (2020)
2021-03-29
In 2020, the National Medical Device Adverse Event Monitoring Information System has received a total of 536,055 reports of medical device adverse events, showing an increase of 35.25% compared with the previous year.
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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.
