Eligibility for application: Application materials for first-time registration of domestic Class II medical devices:
Medical device registration application materials
(1) Medical device registration application form ;
(2) Medical device manufacturer qualification certificate: including production enterprise license and copy of business license; the declared products should be within the production scope approved by the license;
(3) ) Product technical report; should include at least the basis for determining technical indicators or main performance requirements;
(4) Safety risk management report; Prepared in accordance with the requirements of the YY0316 "Medical Device Risk Management" standard. There should be analysis and corresponding preventive measures from five aspects: energy hazards, biological hazards, environmental hazards, hazards related to use and hazards caused by functional failure, inadequate maintenance and aging.
(5) National standards, industry standards or registered product standards and descriptions; If national standards or industry standards are adopted as applicable standards for products, it should be provided that the applied products comply with the national standards, industry standards, and the product shall bear the responsibility A statement of post-market quality responsibility and description of product models and specifications, and the text of the adopted national standards or industry standards. Registered product standards should be signed and sealed by the production enterprise or the unit entrusted by the production enterprise to draft the standards. The power of attorney entrusted by a manufacturing enterprise to draft standards should indicate that "the manufacturing enterprise is responsible for product quality."
(6) Product performance self-test report; Product performance self-test items are factory test items specified in the registered product standards, and should be signed by the chief inspector and auditor. If an enterprise implements national standards and industry standards, it should supplement its own factory testing items.
(7) Product registration test report issued by a medical device testing agency recognized by the State Food and Drug Administration; For medical devices that require clinical trials, a test report issued within six months before the start of clinical trials should be submitted. For medical devices that do not require clinical trials, a test report issued within one year before registration acceptance should be submitted. To implement the provisions of Articles 11, 12, 13 and 14 of these Measures, corresponding explanatory documents shall be provided.
(8) Clinical trial data from two or more clinical trial bases;
(9) Product instructions for use;
(10) Product production quality system assessment (Certification) Valid supporting documents; According to the requirements for different products, provide corresponding quality system assessment reports: 1. System assessment report within the validity period signed by the Provincial People’s Government (Food) and Drug Administration; 2 , medical device production quality management specification inspection report, or medical device quality system certification; 3. If the country has implemented production implementation details, submit an implementation details inspection and acceptance report;
(11) The submitted materials are authentic Sexual Self-Assurance Statement. It should include a list of submitted materials and the manufacturer's commitment to assume legal responsibility. Processing procedures:
Processing procedures and time
1. Acceptance (5 working days, not included in the approval time limit)
2. Review (40 working days day)
3. Review (10 working days)
4. Approval (10 working days)
5. Notification (10 working days, Not included in the approval time limit) Basis for processing:
1. "Regulations on the Supervision and Administration of Medical Devices"
2. "Measures for the Registration and Management of Medical Devices
Remarks and Precautions
1. The person in charge of the enterprise should have a technical secondary school (high school) degree or above, and be familiar with the laws and regulations related to the supervision and management of medical devices and the medical device products they operate.
2. The person in charge of quality of the operating enterprise should have a college degree or above or an intermediate professional title or above, be familiar with the laws and regulations related to the supervision and management of medical devices and the quality standards of the medical device products they operate, and have been trained and passed the assessment. Require.
3. Enterprises should set up quality management and inspection (verification) institutions that are commensurate with their business scale and business scope to perform quality management and quality verification functions. Enterprises should have dedicated quality inspection sites and corresponding testing equipment and measuring instruments, which should be used within the validity period.
4. Enterprises should be equipped with relevant professional after-sales service personnel, with the ability to provide maintenance and other after-sales services that are commensurate with the business scale and business varieties, or agree to have a third party provide technical support.
5. Enterprises should be equipped with quality inspection (verification) personnel (not less than 2 people). The quality inspection (verification) personnel of operating enterprises should have a high school degree or above, be familiar with the quality standards of the products they operate, be trained and qualified, and have the ability to inspect (verify) the products they operate.
Enterprise quality controllers and quality inspectors are not allowed to work part-time outside the company. Anyone who hires retired, internally retired or resigned personnel must provide relevant certificates from the original unit.
6. Enterprises should establish health records of personnel. Personnel who are in direct contact with sterile equipment should undergo health examinations every year, and those found to be suffering from infectious diseases, skin diseases, mental illness, etc. should be transferred to other posts in a timely manner.
Facilities and equipment
1. Have a business place suitable for the scale of business. The business area is generally not less than 30 square meters; the storage area should be commensurate with the business scale. Residential buildings cannot be used as offices, operations, and storage sites for enterprises.
2. Have a relatively independent business location that is suitable for the business scale and scope; the surrounding environment is clean and tidy. The business address of the business should be consistent with the registered address.
3. The medical device products displayed on the business facade should be neatly arranged according to categories, specifications, etc., and the category labels should be placed accurately and clearly written.
4. The storage of sterile medical devices should comply with the storage regulations of product standards.
5. Warehouses and warehousing facilities should comply with the storage and custody requirements of the medical devices they operate, and should have fire-proof, moisture-proof, dust-proof, rodent-proof, and insect-proof facilities.
6. The warehouse should be clean and tidy, with tight doors and windows, a flat and seamless floor, and should be separated from the business, office and living areas.
7. The storage of medical devices shall be managed by zoning and classification, and shall be divided into qualified areas, unqualified areas, pending inspection areas and return areas, and shall be stored according to product categories and batches; various markings such as expiration dates shall be clear; The warehouse should have equipment and facilities that are suitable for storage requirements and should be kept intact, such as temperature and humidity meters, pads, shelves, light-proofing or temperature control equipment, and lighting, fire protection, and ventilation facilities that meet safety requirements.
8. Have storage conditions suitable for the scale and scope of business. Medical devices that have special requirements for storage and handling should have special warehouses and storage conditions.
9. Enterprises that concurrently operate or professionally represent medical device products should have relatively independent operating and warehousing sites or areas, medical device quality management institutions or management personnel and management systems, and display of medical device products. and storage must not be mixed with other products.
System and Management
1. Enterprises should establish and improve necessary management systems in accordance with relevant national and local regulations and strictly implement them.
The system includes: ① Quality responsibility system at all levels; ② Product certification system; ③ Product quality verification, storage, maintenance and warehouse review system; ④ Validity product management system; ⑤ Unqualified product management system ; ⑥Purchase and sales record file system; ⑦Quality review system for first-time operating varieties; ⑧Document management system; ⑨Product after-sales service system; ⑩Quality tracking and adverse event reporting system.
2. Develop relevant procedural documents in key aspects such as procurement control, incoming goods acceptance, warehousing management, quality accidents,
non-conforming incident reporting and handling of non-conforming products.
3. Collect and save laws, regulations, and rules related to business operations
4. Collect and save technical standards at all levels related to the products operated.
5. The enterprise must confirm the legal qualifications of the first-time supplier, and check the "Medical Device Production Enterprise License", "Medical Device Product Registration Certificate", product certificate and other relevant supporting documents.
6. Enterprises should confirm the ability of the first supplier to fulfill the contract, request product quality standards, sign a quality assurance agreement, keep relevant supporting documents, and establish file management.
7. Quality verification personnel should verify the quality of medical devices batch by batch in accordance with relevant standards and contracts, and keep records.
8. The custodian is familiar with the quality, performance and storage conditions of medical devices and accepts them with the warehousing voucher signed by the verification personnel. Medical devices with abnormal quality and unclear markings should be rejected.
9. The purchase acceptance, outbound sales, etc. of medical devices should be carefully recorded.
(Special books are required for sterile and implantable medical devices).