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Recently, the Anhui Provincial Food and Drug Administration took the lead in promulgating the Implementation Rules for the Graded Supervision of Medical Device Production in Anhui Province (hereinafter referred to as the "Implementation Rules") to promote the scientific and reasonable allocation of regulatory resources and accurately implement the graded supervision of medical device production under the medical device registrant system
.
.
The Detailed Rules for Implementation take risk management as the main line
.
Integrating the operation status of the quality management system, supervision and sampling results, adverse event monitoring, complaints and reports, enterprise credit and other factors, the medical device registrant, recordation holder, and entrusted manufacturer are divided into four levels, with four levels of supervision for high risk and first-level supervision for lower risk, and clarify the inspection frequency, full coverage requirements of the four regulatory levels, and the division of responsibilities of provincial and municipal drug regulatory departments
.
.
Integrating the operation status of the quality management system, supervision and sampling results, adverse event monitoring, complaints and reports, enterprise credit and other factors, the medical device registrant, recordation holder, and entrusted manufacturer are divided into four levels, with four levels of supervision for high risk and first-level supervision for lower risk, and clarify the inspection frequency, full coverage requirements of the four regulatory levels, and the division of responsibilities of provincial and municipal drug regulatory departments
.
The Detailed Rules for Implementation are based on
credit supervision.
According to the credit situation of enterprise supervision, 14 specific situations have been created to raise the first, second and highest regulatory levels, so as to achieve accurate, timely and dynamic adjustment
of supervision levels.
For enterprises with good long-term quality management status and regulatory credit status, provisions are made that
the supervision level may be lowered as appropriate.
credit supervision.
According to the credit situation of enterprise supervision, 14 specific situations have been created to raise the first, second and highest regulatory levels, so as to achieve accurate, timely and dynamic adjustment
of supervision levels.
For enterprises with good long-term quality management status and regulatory credit status, provisions are made that
the supervision level may be lowered as appropriate.
The Detailed Rules for Implementation use comprehensive supervision as a means
.
Encourage provincial and municipal drug regulatory departments to carry out joint supervision of enterprises that are both medical device registrants and recordation holders, using various forms such as routine inspections, project-wide inspections, follow-up inspections, non-advance notification inspections, and special inspections, strengthen the linkage between supervision and inspection, supervision and audit, and execution, improve the working mechanisms for investigation, analysis and evaluation, collective consultation, and system governance of potential risks, and comprehensively strengthen the supervision and management of medical device registrants, recordators and entrusted manufacturers
。
.
Encourage provincial and municipal drug regulatory departments to carry out joint supervision of enterprises that are both medical device registrants and recordation holders, using various forms such as routine inspections, project-wide inspections, follow-up inspections, non-advance notification inspections, and special inspections, strengthen the linkage between supervision and inspection, supervision and audit, and execution, improve the working mechanisms for investigation, analysis and evaluation, collective consultation, and system governance of potential risks, and comprehensively strengthen the supervision and management of medical device registrants, recordators and entrusted manufacturers
。
The Implementation Rules also combine the development status of the medical device industry in the province and the risk degree of listed products, and on the basis of the National Catalogue of Key Supervised Varieties of Medical Device Production, 10 key products of Anhui Province are added, forming the Catalogue of Key Supervised Varieties of Medical Device Production in Anhui Province (2022).
The Implementing Rules shall come into force
on January 1, 2023.
The Implementing Rules shall come into force
on January 1, 2023.
