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)
In 2021, NMPA continues to encourage high-quality development of medical device industry through innovation pathway, priority pathway, real world data pilot pathway, AI and combo support.
Innovation pathway
In 2021, NMPA approved 35 innovative medical devices such as coronary blood flow reserve fraction calculation software. By the end of 2021, 134 innovative medical devices have been approved to meet the needs of the patients to use high-level medical devices.
Priority pathway
According to the approval procedure of priority medical devices, 19 medical devices such as genetic deafness gene detection kit were approved. By the end of 2021, 49 priority medical devices were approved, so as to better meet the needs of clinical use.
AI support
NMPA established a biomaterial innovation cooperation platform, cooperating with MIIT to launch the task of artificial intelligence medical device innovation, creating a master document registration system, accelerating the approval of new materials, new technologies and new products, and helping the high-quality innovation and development of the industry.
In 2021, NMPA continues to consolidate the foundation of medical device registration management, ensuring the medical device developing sound and health.
Medical Device Standards
NMPA established two standard formulation organizations of medical device evaluation and medical high-throughput sequencing for more sound standard organizations; approved the revision plans of 79 industry standards and the issuance of 146 industry standards; evaluated 396 mandatary standards and another 62 under-research mandatory standards. Till the end of 2021, China has 1849 current effective medical device standards, of which 235 national standards, 1614 industry standards.
Classification identification
In 2021, NMPA published the Working Procedures for Classification Catalogue Dynamic Adjustment, completed 1993 classification identifications; revised Class I Medical Device Catalogue; formulated IVD Classification Rules; set up the classification rules of recombinant collagen and artificial intelligence products; pushed forward the classification of aesthetic products, edge products and combo products; issued 9 naming guidelines to further lead the standardized naming of medical devices.
In 2021, NMPA continues to strengthen the supervision and management of medical device registration.
Class I filing surveillance
NMPA focused on class I filing surveillance of medical cooling pad. NMPA and local NMPA assigned six teams to do audit in 11 provinces. NMPA will continue to do audit on post-market surveillance in 2022.
Clinical trial management
NMPA strengthens the surveillance of clinical trial sites and projects. During an audit on an IVD clinical trial of a Guangzhou company, NMPA found the issue of clinical trial data unable to be traceable, resulting in punishment as pe regulations.
