The State Food and Drug Administration issued guidance on strengthening the hierarchical supervision of medical device production and operation

According to the news on the website of the State Food and Drug Administration on September 9, the Comprehensive Department of the State Food and Drug Administration issued guidance
on strengthening the hierarchical supervision of medical device production and operation.
In order to implement the Regulations on the Supervision and Administration of Medical Devices, implement the requirements of the Measures for the Supervision and Administration of the Production of Medical Devices and the Measures for the Supervision and Administration of the Operation of Medical Devices, further strengthen the supervision of the production and operation of medical devices, scientifically and rationally allocate regulatory resources, ensure the safety and effectiveness of medical devices in accordance with the law, and promote the new improvement of the quality and safety level of medical devices, the following guiding opinions
are hereby proposed 。 I.
General Requirements Drug supervision and management departments at all levels shall conscientiously implement the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of the Production of Medical Devices, and the Measures for the Supervision and Administration of the Operation of Medical Devices, and carry out hierarchical supervision of the production and operation of medical devices in accordance with the principle of "risk classification, scientific supervision, comprehensive coverage, dynamic adjustment, implementation of responsibilities, and improvement of efficiency", consolidate the regulatory responsibilities of drug regulatory departments at all levels, establish and improve a scientific and efficient regulatory model, and strengthen the supervision and management of medical device production and operation.
Ensure the safety
of people's weapons.
Second, carry out the supervision of the production of medical devices (1) Implement the responsibility
of production classification supervision.
The State Drug Administration is responsible for guiding and inspecting the grading supervision of medical device production nationwide, and formulating a catalogue of key supervised varieties for medical device production; The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for formulating the catalogue of key varieties of medical device production in their respective administrative regions, and organizing the implementation of graded supervision of medical device production; The departments responsible for drug supervision and management at the districted municipal level shall be responsible for the specific work
of the production and grading supervision of class I medical devices in their respective administrative regions in accordance with their duties.
(2) Determine the catalogue
of key varieties of supervision in light of actual conditions.
The State Drug Administration formulates and dynamically adjusts the catalogue of key supervised varieties for the production of medical devices according to the degree of risk of medical device products; The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall comprehensively analyze factors such as the number of registrations of similar products in their respective administrative regions, their market share, the overall level of production quality management, and the risk consultations, supplement the catalogue formulated by the State Drug Administration, determine the catalogue of key supervised varieties for the production of medical devices in their respective administrative regions, and dynamically adjust
them.
For medical device registrants entrusted with cross-regional production, the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government where the registrant is located shall be responsible for studying and determining whether their products are included in the catalogue
of key supervised varieties for the production of medical devices in the administrative region.
(3) Formulate detailed provisions on
hierarchical supervision.
The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate and issue detailed regulations on the grading supervision of medical device production in light of the industrial development of the administrative region, the quality management status of enterprises and the allocation of regulatory resources, clarify the principle of dividing the regulatory level, and supervise and inspect the form, frequency and coverage
of the recorders of medical device registrants and entrusted production enterprises at different regulatory levels 。 The classification and inspection requirements of the supervision level may be in accordance with the following principles: Implement four-level supervision for enterprises with a high degree of risk, mainly including the production of key varieties of products under supervision in the administrative region, as well as enterprises with poor quality management system operation and serious bad regulatory credit records; Implement three-level supervision for enterprises with a high degree of risk, mainly including the production of class III medical devices in addition to the catalogue of key varieties under supervision in the administrative region, as well as enterprises with poor quality management system operation and bad regulatory credit records; Implement secondary supervision of enterprises with a general degree of risk, mainly including enterprises that produce Class II medical devices in addition to the catalogue of key varieties under supervision in the administrative region; Implement first-level supervision for enterprises with a low degree of risk, mainly including enterprises that produce Class I medical devices
.
Where multiple levels of supervision are involved, regulation is carried out at the highest level
.
Under normal circumstances, for enterprises that implement four-level supervision, the whole project is inspected no less than once a year; For the implementation of three-level supervision, the inspection shall be carried out not less than once a year, of which the whole project shall be inspected not less than once every two years; For the implementation of secondary supervision, in principle, inspections shall be carried out not less than once every two years; For the implementation of first-level supervision, in principle, more than 25% of the enterprises in the administrative region are randomly selected every year to supervise and inspect, and the new first-class medical device manufacturers are to carry out on-site inspections within 3 months from the date of production filing, and if necessary, the first-class medical device manufacturers who change the production address or increase the production scope are subject to on-site verification
.
Supervision and inspection can be combined with product registration system verification, production license change or continuation of on-site verification to improve the effectiveness
of supervision.
The whole project inspection refers to the inspection carried out by the drug supervision and management department on the supervision object covering all applicable items in accordance with the good manufacturing practices of medical devices and the corresponding appendices
.
The whole project inspection carried out by the registeror of the medical device register entrusted with production shall include the inspection
of the corresponding production activities of the entrusted production enterprise.
(4) Dynamically adjust the level
of supervision.
The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the detailed provisions on the hierarchical supervision of medical device production, combined with supervision and inspection, supervision and sampling, monitoring of adverse events, product recall, complaints and reports, and case investigation and handling, organize scientific research and judgment on the degree of risk of medical device registrants and entrusted production enterprises in their administrative regions every year, determine the level of supervision and inform enterprises
。 For the medical device registrant recorder and the entrusted production enterprise in the current year, serious quality accidents, new high-risk products, selected products with national centralized quantity procurement, innovative products, etc.
, their regulatory levels
shall be immediately assessed and adjusted 。 For enterprises with a good regulatory credit status for a long time, the regulatory level may be downgraded as appropriate; For medical device registrants who have obtained product marketing licenses by entrusted production methods or through innovative medical device review and approval channels, as well as medical device registrants who have been commissioned to produce across regions, and who only carry out entrusted production, the medical device registrant recorder and entrusted production enterprise of the selected products in the centralized procurement of the state shall raise the regulatory level
as appropriate.
The specific adjustment methods are to be determined
by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government in light of the overall regulatory credit status, the number of enterprises, and the proportion of regulatory resources in that administrative region.
(5) Strengthen supervision and inspections on the basis of the level of supervision
.
The drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with the provisions on hierarchical supervision, formulate annual supervision and inspection plans, clarify the frequency and coverage rate of inspections, and determine the focus of supervision; Adhere to the problem-oriented, comprehensive use of supervision and inspection, key inspections, follow-up inspections, cause inspections, special inspections and other forms to strengthen supervision and management
.
Supervision and inspection may be conducted in a non-pre-informed manner, and in principle, key inspections, factorized inspections, and special inspections shall be conducted
in a non-pre-informed manner.
For medical device registrants and their entrusted production enterprises that have obtained product marketing authorization through the review and approval channel of innovative medical devices of the State Drug Administration, the regulatory risk points and regulatory measures determined by the innovative medical device regulatory consultation shall be fully considered; For enterprises that cannot continue to operate effectively due to production suspension, the quality management system should track and grasp the relevant situation and take targeted regulatory measures
.
Third, carry out hierarchical supervision of medical device business (6) Implement the responsibility
of hierarchical supervision of operation.
The State Drug Administration is responsible for guiding and inspecting the grading supervision of medical device business in the country, and formulating a catalogue of key supervised varieties for medical device business; The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for guiding and inspecting the departments responsible for drug supervision and management at the districted municipal level to implement the hierarchical supervision of medical device business; The department responsible for drug supervision and management at the districted municipal level is responsible for formulating a catalogue of key supervised varieties for medical device business in its administrative region, and organizing the implementation of hierarchical supervision of medical device business; The county-level department responsible for drug supervision and management is responsible for the specific work
of graded supervision of medical device business in its administrative region.
For medical device trading enterprises that add warehouses across districted cities, in accordance with the principle of territorial management, the department responsible for drug supervision and management at the districted municipal level where the operating enterprise and warehouse is located is responsible for determining its supervision level and implementing supervision work
.
(7) Determine the catalogue
of key varieties of supervision in light of actual conditions.
The State Drug Administration shall formulate and dynamically adjust the catalogue of key regulated varieties for medical device business according to the degree of risk of medical device products and product operations (see Annex 2); The department responsible for drug supervision and management at the districted municipal level shall comprehensively analyze factors such as product supervision and sampling, adverse event monitoring, product recall, quality complaints, risk consultation, etc.
, supplement the catalogue formulated by the State Drug Administration, determine the catalogue of key supervised varieties of medical device business in the administrative region and dynamically adjust
it.
For medical device trading enterprises that add warehouses across districted cities, the department responsible for drug supervision and management at the districted municipal level where the warehouse is located is responsible for determining whether the products in their inventory belong to the key supervision products
of medical device business in the administrative region.
(8) Formulate detailed provisions on
hierarchical supervision.
The department responsible for drug supervision and management at the districted municipal level shall formulate and issue detailed regulations on hierarchical supervision and control according to the degree of risk, business format, quality management level and enterprise supervision credit of medical device operations in the administrative region, combined with factors such as adverse events of medical devices and product complaints, clarify the principle of dividing regulatory levels, and supervise and
inspect medical device trading enterprises at different regulatory levels 。 The classification of regulatory levels and inspection requirements can be carried out in accordance with the following principles: Implement four-level supervision for enterprises with high risk levels, mainly including "providing storage and transportation services for other medical device registrants, recorders and production and operation enterprises" and key inspection enterprises determined by risk consultations; Implement three-level supervision for enterprises with a high degree of risk, mainly including the catalogue of key supervised varieties of medical device business in the administrative regionWholesale enterprises involved in the product, operating enterprises that have administrative penalties or bad regulatory credit records in the previous year; Implement secondary supervision over enterprises with a general degree of risk, mainly including wholesale enterprises operating Class II and III medical devices other than Grade III and IV supervision, and retail enterprises involved in the catalogue of key supervised varieties of medical devices in the administrative region; Implement first-level supervision of enterprises with low risk levels, mainly including other medical device trading enterprises
in addition to second-, third- and fourth-level supervision.
Where multiple regulatory levels are involved, they are regulated
at the highest level.
Enterprises that implement four-level supervision, the department responsible for drug supervision and management at the districted municipal level organizes the inspection of the whole project at least once a year; Enterprises that implement three-level supervision, the department responsible for drug supervision and management at the districted municipal level organizes inspections not less than once a year, of which the whole project is inspected not less than once every two years; Enterprises that implement secondary supervision, the county-level department responsible for drug supervision and management organize inspections not less than once every two years, and retail enterprises with corneal contact lenses and protective products can determine the frequency of inspections according to regulatory needs; For enterprises that implement first-level supervision, the county-level department responsible for drug supervision and management shall, in accordance with relevant requirements, randomly select more than 25% of enterprises in the administrative region for supervision and inspection every year, and achieve full coverage
within 4 years.
When necessary, on-site verification
will be conducted on the newly added business formats.
The whole project inspection refers to the inspection carried out by the drug supervision and management department on the operating enterprises in accordance with the medical device business quality management specifications and corresponding appendices
, covering all applicable items.
The inspection of the whole project carried out by the operating enterprise "specially providing storage and transportation services for other medical device registrants, record-filers and production and operation enterprises" shall include a random inspection
of the entrusted operating enterprise.
(9) Dynamically adjust the level of
supervision.
The department responsible for drug supervision and management at the districted municipal level shall, in accordance with the detailed provisions of the hierarchical supervision of medical device business, on the basis of comprehensive and effective collection of medical device products, enterprises and supervision, organize an annual assessment of medical device trading enterprises in the administrative region and medical device trading enterprises that have increased warehouses across districted cities, scientifically judge the degree of risk of enterprises, determine the level of supervision and inform enterprises
.
For special circumstances such as new business formats, the level
of enterprise supervision can be determined or adjusted immediately.
For enterprises with good regulatory credit for a long time, the regulatory level may be downgraded as appropriate; Enterprises that have serious violations of laws and regulations, add warehouses in different places, and operate products selected by the state with centralized procurement and products for epidemic prevention and control shall raise the level
of supervision as appropriate.
The specific adjustment method is to be determined
by the districted municipal department responsible for drug supervision in combination with the overall regulatory credit status of the enterprises in the administrative region, the number of enterprises, and the proportion of regulatory resources.
(10) Strengthen supervision and inspections on the basis of the level of supervision
.
Local departments responsible for drug supervision and management at all levels shall, according to the level of supervision, formulate annual supervision and inspection plans, and clarify the inspection focus, inspection method, inspection frequency and coverage rate
.
In principle, the inspection method shall adopt surprise supervision and inspection, encourage the use of modern information technology means to carry out supervision and management, and improve the efficiency and level of
supervision.
IV.
Strengthen Supervision and Management and Improve the Effectiveness of Supervision (11) Strengthen organizational leadership
.
Drug supervision and management departments at all levels should earnestly improve their political standing, and fully understand the importance of further strengthening hierarchical supervision, improving regulatory efficiency, and promoting risk governance under the situation of a significant increase in the number of regulatory objects, the full implementation of the registrant recorder system, and the emergence of new business formats
。 All provincial-level drug supervision and management departments should follow the unified deployment of the State Drug Administration, strengthen overall planning and coordination, play a leading role, establish and improve cross-regional and cross-level collaborative supervision mechanisms, strengthen coordination and cooperation, strengthen supervision and guidance of the work of departments responsible for drug supervision and management at the municipal and county levels, link up and down, and promote the hierarchical supervision of
medical device production and operation as a whole.
(12) Strengthen the handling of
problems.
Local drug supervision and management departments at all levels shall implement the "four strictest" requirements, and deal with problems found in strict accordance with laws, regulations, rules, standards, norms and other requirements, and where major problems are involved, they shall promptly dispose of them and report
to the drug supervision and management department at a higher level.
For new problems in the development of the industry, the relevant drug regulatory departments should timely adjust and improve the detailed provisions of hierarchical management, realize the precision, scientific and effectiveness of supervision, and ensure full coverage and seamless supervision
.
Each provincial-level drug supervision and management department shall regularly organize experts to study and judge the safety situation of medical device production and operation in its administrative region, analyze common problems, prominent problems, and weak links, put forward improvement measures, and form an annual report
.
(13) Strengthen capacity-building
.
Drug supervision and management departments at all levels should continue to strengthen capacity building, improve the inspection and law enforcement system and the inspection and case handling mechanism, enrich the professional team of inspectors, strengthen the construction of the inspection team, innovate inspection methods and methods, and strengthen the coordination of inspection and inspection and law enforcement linkage
.
Drug supervision and management departments at all levels should find out the shortcomings of regulatory capacity, clarify the objectives and construction directions of regulatory capacity building, enrich regulatory resources, promote scientific distribution, boost the high-quality development of the medical device industry, and better meet the people's demand for
medical device safety.
These Guidelines shall take effect on
January 1, 2023.
Former State Food and Drug Administration Notice on Printing and Distributing the Provisions on the Classification and Grading Supervision and Administration of Medical Device Manufacturers (Food and Drug Administration [2014] No.
234), Notice on Printing and Distributing the Catalogue of Medical Devices Under Key National Supervision (Food and Drug Administration [2014] No.
235), Notice on Printing and Distributing the Provisions on the Classification and Grading Supervision and Administration of Medical Device Trading Enterprises (Food and Drug Administration [2015] No.
158) and The catalogue of key supervision of medical device business links and the key contents of on-site inspection (Food and Drug Administration [2015] No.
159) shall be abolished
at the same time.