Application for licensing acceptance criteria:
Terms
Assessment items and content
Review method
Full marks
Scores
Deductions or reasons for failure
1
Personnel
70 points
1.1
Enterprises should have sufficient human resources. The person in charge of the enterprise and the quality management personnel should be familiar with the national rules, regulations and policies on the management of medical devices.
(1) Check the list of registered personnel of the enterprise.
(2) Answer the questionnaire or on-site question and answer.
10 points
1.2
The legal representative or person in charge of an enterprise dealing with Class II medical devices shall have a secondary school education or a professional and technical title above junior level; the legal representative or person in charge of an enterprise dealing with Class III medical devices shall have a college education or a professional and technical title above intermediate level; the person in charge of the enterprise shall not be employed part-time.
(1) Check the appointment documents.
(2) Check the original certificate of academic title.
(3) Check the labor contract
20 points
1.3
The person in charge of quality management of the enterprise operating the second class of medical devices shall have the education of college degree or above in related majors or junior professional and technical titles; the person in charge of quality management of the enterprise operating the third class of medical devices shall have the education of bachelor degree or above in related majors or intermediate or above professional and technical titles; And shall not be part-time.
(1) Check the appointment documents.
(2) Check the original certificate of academic title.
(3) Check the labor contract
No
Decision
Item
1.4
Enterprises engaged in quality management and the person in charge of each department should be familiar with the state's laws, rules and regulations relating to medical devices, and the professional knowledge of the medical devices they deal with, as well as the quality management system and post work procedures developed by the enterprise.
Answer sheet or on-site question and answer, which should include the person in charge of quality management.
10 points
1.5
Operating Class III medical device products, Class II medical devices 5 or more categories of enterprises should be not less than three full-time managers of the quality management organization; Class II medical devices less than five categories of enterprises should be not less than two full-time quality inspection personnel, full-time managers of the quality management organization should have relevant professional college Above education or junior professional and technical titles; and maintain relative stability.
(1) Check the appointment documents.
(2) Labor contract.
(3) Check the original certificate of academic title.
10 points
1.6
Personnel engaged in the work of acceptance, maintenance, as well as operation and storage should have a high school education level or above, and the above personnel must be trained by the relevant departments, and be issued with a certificate of qualification of the position after passing the examination before they are allowed to work.
The personnel should be familiar with the product characteristics of the products they handle.
(1) Check the appointment documents.
(2) Check the original certificate of education.
(3) Labor contract.
(4) Check the certificate of training qualification.
20 points
1.7
Operation of equipment class medical device products, should be compatible with its scale of operation of after-sales service personnel familiar with the product performance; business scope of the third category of medical devices 5 and 5 categories of the following should have the relevant professional college degree or above, or intermediate or above the technical title of the personnel of the technical training, after-sales service personnel 1; each additional 2 categories increase 1 college degree or above, or intermediate or above technical title of technical personnel; business scope for the second category of medical devices 5 and 5 categories of the following should have a related professional college degree or above, or junior technical title of technical training, after-sales service personnel 1; each additional 2 categories increase 1 college degree or above, or junior or above technical title of technical personnel;
Business The need for fitting class medical device products, should be equipped with its scale of operation in line with the ability to meet the fitting requirements of professional fitters (contact lens fitters or professional audiometrists), should be not less than 2.
(1) Check the relevant training materials.
(2) Check the labor contract.
(3) Check the proof of academic title.
No
Decision
Item
2
Institutional setup
20 points
2.1
Enterprises should set up an organizational structure appropriate to the scale of operation and product varieties; they should set up quality acceptance agencies and acceptance, maintenance, after-sales service and other organizational structures or personnel. The responsibilities of institutions and personnel at all levels should be clear, the main person in charge of the quality of business operations of the enterprise is responsible for leadership. Enterprises should be set up to the main person in charge of quality management of the leading organizations, exercise quality management functions, within the enterprise on the quality of medical equipment products have the right to rule.
(1) Check the organization chart of the enterprise.
(2) Check the organization set up documents and institutional responsibilities.
20 points
2.2
Enterprise quality inspection and acceptance of the organization should be equipped with appropriate instruments and equipment; does not have the ability to test, provide a third party to provide technical support (quality and technical assurance) of the proof.
(1) check the site and instruments and equipment
(2) check the quality assurance agreement
(3) check the product testing report
No
Decision
item
2.3
Enterprises dealing with medical equipment products that require fitting should have the appropriate fitting capabilities; set up suitable fitting organizations ; with suitable equipment and instruments. (Business contact lenses should have visual acuity meter, inspection lens, lens box, computerized optometry or comprehensive optometry, slit lamp, focus meter, keratoconus and other equipment, instruments; business hearing aid companies should have audiometric room, audiometer, fitting special computer, computer programming instrument, programming line, take ear samples of a set of tools ----- to take ear samples of the material, otoscope combinations, ear samples of the injection gun)
(1) institutional setup documents
(2) check the site equipment, instrumentation status
(3) check the equipment, instrumentation invoices
No
Decision
item
3
Premises and facilities
90 points
3.1
Enterprises should have with the scale of operation of the
Enterprises dealing with Class II medical devices should be no less than 50 square meters; enterprises dealing with Class III medical devices, Class II large and medium-sized equipment should be no less than 100 square meters (except as otherwise provided).
Enterprises dealing with a single product such as hearing aids, contact lenses, etc. shall have an area of not less than 45 square meters.
Registered business premises shall not be set up in a residence, not in the residential portion of a commercial or residential building, and shall not be used for living purposes.
(1) check the site
(2) check the proof of housing (including rental contracts, real estate certificates)
No
Decision
item
3.2
Enterprises should have with the scale of operation and scope of business is compatible with the relative independence of the products in line with the standards specified in the conditions of the warehouse, warehouse building adjacent to the environment should be neat and clean. No dust, no garbage, no harmful gases and sewage and other serious sources of pollution.
Enterprises operating consumable medical device products, the warehouse shall not be less than 100 square meters; the operation of single-use sterile medical devices (Class III injection and puncture instruments, medical polymer materials and products) products, the warehouse shall not be less than 200 square meters; general medical device products, the warehouse shall not be less than 50 square meters (except as otherwise provided), with product characteristics of equipment, facilities; only operating medical device products, the warehouse shall not be less than 50 square meters (except as otherwise provided), with product standards. Characteristics of the equipment, facilities; only fixed permanent installation of large-scale medical equipment business can not have a warehouse.
Hearing aids, contact lenses and other single product business warehouse area of not less than 20 square meters.
The warehouse site shall not be set up in a residence, not in the residential part of a commercial or residential building, and shall not be used for living purposes.
(1) check the site (storage area independent)
(2) check the real estate certificate (including rental contracts, real estate certificates)
(3) check the equipment, facilities
No
Decision
Items
3.3
Enterprises should have with the scale of operation and business products, relatively independent and convenient operation of the quality inspection site (quality inspection). The quality of the acceptance of the premises (quality inspection room), and equipped with inspection and maintenance equipment appropriate to the business varieties, quality inspection room area of not less than 15 square meters.
Hearing aids, contact lenses and other medical devices need to be fitted products should be set up not less than 10 square meters of the inspection room.
(1) check the site
(2) check the property certificate (including rental contracts, real estate certificates)
(3) check the equipment and facilities
20 points
3.4
Business premises should be spacious, clean, bright, equipped with telephone, fax, computer and other office facilities, set up a product display room or showcase, the main products should be displayed visible, large-scale products should be visible. The main products should be displayed visible, large-scale equipment can not be displayed should be hung product pictures; business needs to be fitted with medical equipment products must be set up in the examination room, such as fitting places, fitting table and hand-washing sink, the site has good hygiene conditions.
(1) check the site
(2) check the site equipment, instrument status
(3) check the equipment, instrument invoices
10 points
3.5
Warehouse should be delineated and partitioned, the implementation of the color-coded management, unified provisions for the (three-color, five-zone): to be inspected warehouse (zone) yellow; qualified goods warehouse (zone) green; shipping warehouse (zone) green; non-conforming goods warehouse (zone) green; the warehouse (zone) green. Green; non-conforming library (area) red; return library (area) yellow and other specialized places, the above libraries (areas) should be equipped with obvious signs.
Medical polymer products, implantable materials and artificial organs and other products such as temperature and humidity requirements of the product technical standards should have a cool library (0-20 ℃), room temperature library (0-30 ℃).
Operation of in vitro diagnostic reagents and other products that require refrigeration should have a cold storage (2-10 ℃) conditions, or not less than three refrigerated boxes.
(1) check the site (whether the areas are set up reasonably, easy to operate)
(2) check the equipment, instrument invoices
20 points
3.6
Warehouses should be in line with the requirements for the storage of products, and should be:
1) the site and the products are clean and hygienic.
2) Equipment to maintain a certain distance between the product and the ground (floor mats).
3) Equipment to avoid light, ventilation and drainage, detect and regulate temperature and humidity.
4) Equipment to prevent dust, moisture, mold, pollution, and insects, rodents and birds.
5) expiration date goods should be classified according to batch number centralized stacking, according to the batch number and expiration date far into the sequential stacking, and have obvious signs.
6) Lighting equipment that meets the requirements of safe electricity.
7) loading and unloading of goods outside the door should prevent rain roof.
Check the site, check the facilities, equipment status and (purchase) vouchers
20 points
3.7
Goods with special requirements should have storage conditions in line with their characteristics, such as stomatological materials, volatile liquids, toxic products and hazardous materials should be stored in a special room storage and custody as required. Double double-locked custody, special account records, should have the appropriate safety and security measures.
Check the site, check the records
10 points
3.8
Registered business, warehouse site should meet the fire and safety requirements.
Check the site
10 points
4
Management Documents
150 points
4.1
Enterprises should timely collect and keep the rules and regulations related to business.
Check on-site documentation
20 points
4.2
Enterprises should collect and keep product technical standards and information related to the products they operate.
Check the site standards, information
No
Decision
Item
4.3
Enterprises should be based on the relevant national laws and regulations, combined with the actual enterprise and the characteristics of the products of the medical devices operated in the establishment of quality management system, combined with the actual enterprise and the characteristics of the products of the medical devices operated in the establishment and implementation of the actual Medical device quality management system, and regularly check and assess the implementation of the quality system, quality management system should at least include: (1) quality policy and management objectives; (2) quality system audit; (3) quality responsibility system at all levels; (4) quality veto system; (5) business quality management system; (6) the first operating variety quality audit system; (7) quality acceptance, storage and warehousing review system; (8) Unqualified goods management and returned goods management system; (9) quality incident reporting, quality inquiries and complaints management system; (10) after-sales service management and user access system; (11) quality information management system; (12) quality records management system; (13) adverse event monitoring and reporting system; (14) personnel education and training system; (15) the implementation of the relevant systems Assessment system; (16) special products special management system. (17) business need to dispense products (such as hearing aids, contact lenses) enterprises should also develop: dispensing personnel duties, dispensing management system, dispensing product quality testing system, health system.
(1) Check the completeness, rationality, operability of the system. (At least 3 systems)
(2) Check the implementation of the system. (At least 3 systems)
40 points
4.4
Enterprises should formulate program documents for key aspects of quality management. Key aspects of the procedural documents should include: (1) the first enterprise, species approval procedures; (2) product purchase procedures; (3) quality inspection and acceptance procedures; (4) warehousing and shipping procedures; (5) out of the warehouse review procedures; (6) in-store maintenance procedures; (7) the confirmation of unqualified products procedures; (8) the quality of the information flow procedures; (9) the quality of inquiries, complaints and work procedures; (10) contact lens
Check the rationality,
completeness and operability of the program documents.
20 points
4.5
Enterprises should establish quality management records in accordance with the quality management system, and the quality management records (forms) should at least include: (1). Medical device purchase records, (2) acceptance, inspection records; (3) maintenance and inspection records; (4) out of the warehouse review records; (5) sales records; (6) quality inquiries, complaints records; (7) non-conforming products scrapped, destroyed records; (8) return records; (9) return acceptance records after the sale of the return of the records (10) warehouse temperature, humidity records; (11) instruments, equipment use, calibration records; (12) Quality incident handling, reporting records; (13) Adverse event reporting records; (14) personnel education and training records; (15) management system implementation and assessment records.
(1) check the completeness and authenticity of the records
(2) at least 5 records
40 points
4.6
Enterprises should establish quality management files (forms) should include at least: (1) supplier files; (2) the first enterprise, the species approval file; (3) the quality of medical device product files; (4) sales Personnel files; (5) user files; (6) product after-sales service and maintenance files; (7) product technical data files; (8) product quality problem tracking files; (9) product quality information files; (10) facilities, equipment inspection and maintenance files; (11) personnel training files; (12) staff health files; (13) non-conforming products report form; (14) near-expiry date of the goods call form; (15) adverse event report form and so on. (15) Adverse event report form, etc.
(1) check the completeness and authenticity of the files (forms)
(2) at least 5 files (forms)
30 points
Instructions:
(1) According to the "Regulations on the Supervision and Administration of Medical Devices", "Medical Devices License Management Measures", combined with the actual situation in Sichuan Province, the development of this standard.
(2) This standard applies to the new start-up enterprises to apply for the "Medical Device Business Enterprise License", "Medical Device Business Enterprise License" to change and "Medical Device Business Enterprise License" renewal of the on-site review. The daily supervision and management of medical device business enterprises can refer to the implementation of this standard.
(C) the site area involved in this standard refers to the actual use of the area.
(d) "Medical Device Business License" licensing matters [quality management personnel, registered address, business scope, warehouse address (including the addition or subtraction of warehouses)] changes should be reviewed in accordance with this standard.
(E) the relevant professions mentioned in this standard is associated with the operation of the product, such as the operation of medical electronic instrumentation and equipment class of relevant professions can be: mechanical, electronic, precision instruments and other professions.
(F) this standard enterprise legal person part of four chapters of 24 items, each chapter points are:
1. Personnel : ***7 items, veto 2 items, 70 points for other items;
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4. Management Documents: ***6 items, veto 1 item, other items 150 points
(VII) This standard enterprise branch part of 4 chapters and 19 items, the chapter scores are:
1. Personnel : ***6 items, veto 2 items, other items 50 points;
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3. Site facilities: ***5 items, veto 1 item, other items 60 points;
4. Management documents: ***5 items, veto 1 item, other items 100 points;
(h) the total score of 70% (including 70%) for the qualified, one of the following situations is unqualified:
1. standards have a chapter less than 70% of the total chapter score
2. Where the veto items do not meet the requirements.
(ix) the assessment of the project-by-item evaluation, evaluation using coefficient assessment method, *** divided into five grades:
1. Satisfactory standard score × coefficient 1.0;
2. Implementation of the situation is better, and still need to be improved standard score × coefficient of 0.8;
3. basically meet the requirements of the standard score × coefficient of 0.7;
4. partially meet requirements Standard score × coefficient 0.4;
5. not yet implemented Standard score × coefficient 0;
(j) the inspection does not relate to the provisions of the calculation of the score rate should be deducted from the basic points.
(xi) review conclusions
After the on-site review, the on-site review record should be filled out in a timely manner. According to the review criteria, the on-site review concluded that qualified or unqualified, the reviewer should be in the on-site review of the record "review of the conclusion of the table" (see the table) column to fill in the review, the reviewer, the person in charge of the enterprise should be in the on-site review of the record on the signature and official seal of the enterprise.
(xii) on-site reviewers shall not be less than two people, the reviewers must comply with the medical device approval work discipline.