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NMPA Announcement on Implementing Relevant Matters of the Regulations for the Supervision and Administration of Medical Devices
2021-05-31
The revised Regulations for the Supervision and Administration of Medical Devices will be implemented as of June 1, 2021.
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NMPA Announcement on Approving the Registration of 139 Medical Devices
2021-05-24
In April 2021, NMPA approved the registration of a total of 139 medical devices. Among them, there are 100 domestic Class III medical devices, 19 imported Class III medical devices, 19 imported Class II medical devices, and 1 medical device from Hong Kong, Macao and Taiwan.
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NMPA Announcement on Issuing the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices
2021-05-08
NMPA has organized to formulate the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices, which was issued on April 27.
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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.
