The National Medical Products Administration (“NMPA”) held a meeting to advance the implementation work of the GB 9706 standards on October 13, in which explicit work requirements were put forward and related parties were urged to implement their responsibilities, so as to ensure the smooth and orderly implementation of the new version of GB 9706.1 and supporting standards. Xu Jinghe, the member of Party Group and the Deputy Director of the National Medical Products Administration, attended the meeting and gave a speech.
GB 9706.1-2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance and the supporting collateral and specialized standards that have been released successively since April 2020 will come into force successively from May 1, 2023. As the basic standards for medical electrical equipment, the new version of the standards includes a total of 76. These standards large in number and with big changes, extensive influence and high requirements are of great importance to the high-quality development of the industry. Since the release of the standards, regulatory authorities and related entities have conducted a series of tasks, including research, publicity and training, strengthening of technical guidance, and advancement of inspection qualification accreditation, and strived to advance the preparations for standard implementation, which was affirmed by the meeting. It was also noted at the meeting that in order to effectively implement the standards, industry enterprises, inspection bodies and regulatory authorities need to further deepen their understanding and effectively increase efforts.
Xu Jinghe put forward specific requirements for implementing the new version of GB 9706 standards. Firstly, deeply understanding the significance of implementing the new version of the standards. Changes in the standards will not only have significant implications for the medical device industry but also put forward higher requirements for the related inspection and regulatory work. Regulatory authorities at all levels should attach great importance and ensure the smooth and orderly implementation of the new version of the standards. Secondly, comprehensively implementing the primary responsibilities of registrants and filing parties for implementing the standards. The legal representatives or principals, persons responsible for production, quality and technology, and practitioners in production management and quality inspection positions of related enterprises are required to learn in depth and master the standard requirements, and registrants and filing parties are required to strictly implement the new version of the standards, ensure that products produced from the days the standards come into force meet the new compulsory standard requirements, and accelerate the inspection and registration of products related to the new version of the standards. Thirdly, comprehensively implementing the inspection responsibilities of medical device inspection bodies. Provisional medical products administrations should urge inspection bodies to actively apply for inspection qualification accreditation, and inspection bodies should participate in training related to the new version of the standards to ensure that inspectors can master and apply related standards in their inspection work. Inspection bodies should give priority to inspection applications related to the new version of the standards that will come into force from May 1 next year. Fourthly, comprehensively implementing the regulatory responsibilities of provisional medical products administrations. Provisional medical products administrations should effectively strengthen organization and leadership and supervision and guidance, thoroughly analyze realistic conditions within their jurisdiction for implementing the new version of the standards, develop specific measures, launch training in the new version of the standards that fully covers registrants, filing parties and entrusted manufacturers, mobilize inspection resources within their jurisdiction, and accelerate improvement in the inspection capability, to ensure the effective implementation of the new version of the standards.
At the meeting, the National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration NMPA) presented situations on GB 9706 standards development and revision, publicity and training and standard-related inspection qualification and capability research; around the implementation of the GB 9706 standards, Shanghai, Guangdong and Jiangsu medical products administrations shared information on work such as training and publicity, inspection capability improvement, comprehensive research and survey, and coordination and connection strengthening and gave corresponding suggestions regarding the current problems.
The meeting was held both online and offline. Principals, persons in charge of the related divisions and related personnel of the Department of Medical Device Registration and the Department of Medical Device Regulation of the NMPA as well as related principals and personnel of the National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration NMPA) and the Center for Medical Device Evaluation, NMPA attended the meeting at the main venue, and principals and related personnel of provincial medical products administrations and medical device inspection bodies attended the meeting at sub-venues.
Source: CNDAnews