NMPA New Regulatory Framework Summary In 2021

2022-02-17

In 2021, China NMPA established new regulatory framework for medical device registration. The below is a list of new regulations and updated provisions published by NMPA.

The Administrative Measures for the Registration and Filing of Medical Devices (Order No. 47)
The Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48)
Notice on Matters Related to the Implementation of the Administrative Measures for the Registration and Filing of Medical Devices and the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (No. 76), clarifying the requirements for the registration of medical devices in the transition period.
Announcement on Publishing the Requirements of Medical Device Registration Application Dossiers and the Format of Approval Certificate Documents (No. 121, 2021)
Announcement on Publishing the Requirements of IVD Registration Application Dossiers and the Format of Approval Certificate Documents (No. 122, 2021)
Notice on Issuing the Technical Guidelines for Clinical Evaluation of IVD Reagents Exempted from Clinical trials (No. 74, 2021)
Notice on Issuing the Technical Guidelines for Clinical Trial of IVD Reagents (No. 72, 2021)
Technical Guidelines for Medical Device Clinical Evaluation
Technical Guidelines for Deciding Whether to Carry Out Clinical Trials of Medical Devices
Technical Guidelines for Equivalence Justification of Medical Device Clinical Evaluation
Technical Guidelines for Clinical Evaluation Report of Medical Device Registration
Technical Guidelines for Comparison and Description of Products Listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation
Notice on Issuing Two Guidelines for Registration Review Including the Requirements for Submission of Clinical Trial Data of Medical Devices (No. 91, 2021)
Notice on Issuing the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 70, 2021)
Notice on Issuing the Catalogue of Medical Devices Exempted from Clinical Trials (No. 70, 2021)
Operating Specifications for the Registration Approval of Domestic Class III and Imported Medical Devices (No. 53, 2021)
Operating Specifications for the Registration Approval of Domestic Class II Medical Devices (No. 53, 2021)
The Administrative Provisions on Self-Test for Medical Device Registration
Medical Device Emergency Approval Procedures
Classification Rules for In Vitro Diagnostic Reagents (No. 129, 2021)

Since China NMPA is upgrading the regulations, provisions, measures, standards and guidelines continuously, it is crucial to choose the most feasible registration strategy and the least burden clinical solutions for China registration, which will shorten the timeline to enter China medical device market.

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