What are the conditions for applying for medical device product registration

Hello! The state is very strict on the approval of companies operating Class II medical devices. Generally speaking: a class II medical device registration application materials required 1. Medical device registration application form; 2. Medical device manufacturer qualification certificate: including the manufacturer's license, a copy of the business license, and the product should be applied for in the manufacturer's license approved within the scope of production; 3. Product technical report: at least it should include the technical indicators or the main performance requirements of the determination of the basis of content; 4. Safety Risk Analysis Report: Prepared in accordance with the requirements of 0316 "Medical Device Risk Analysis" standard. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and hazards caused by functional failure, poor maintenance and aging and other five aspects of the analysis and the corresponding precautionary measures; 5. Applicable product standards and instructions: the use of national standards, industry standards as the applicable standards of the product, it should be submitted to the ~ ~ the national standards, industry standards of the text; registered product standards should be signed by the production company. Signature of the enterprise. Production enterprises should provide the application of products in line with national standards, industry standards statement, the production enterprise to assume responsibility for the quality of the products listed on the statement as well as the relevant product model, specification division of the description; 6. Product performance self-test report: product performance self-test project for the registration of product standards for the factory testing program, there should be a principal inspector or the person in charge of the principal inspector, the reviewer's signature. Implementation of national standards, industry standards, the manufacturer should supplement the self-defined factory test items; 7. Medical device testing organizations issued by the product registration test report: the need for clinical trials of medical devices, should be submitted to the start of clinical trials within six months before the start of the test report issued by the medical device testing organization. Do not need to conduct clinical trials of medical devices, should be submitted to the registration acceptance within one year before the test report issued by the medical device testing organization. 8. medical device clinical trial data; 9. medical device instructions; 10. product production quality system assessment (certification) of the effective documents - according to the requirements of different products, provide the appropriate quality system assessment report: (1), the province, autonomous region, municipality directly under the central government (food) drug supervision and management department signed, within the validity of the system assessment report; (2), the medical equipment testing organization should submit the test report within one year before the acceptance of registration. Within the validity period of the system assessment report; (2), medical device production quality management standard inspection report or medical device quality system certification; (3), the state has implemented the implementation of the production rules, the implementation of the rules submitted to the inspection and acceptance of the report; 11. The authenticity of the materials submitted by the self-assurance statement: should include a list of materials submitted, the production company to assume legal responsibility for the commitment. Second, the process: (A) acceptance 1, the applicant in accordance with the requirements of the corresponding materials submitted to the Provincial Food and Drug Administration Medical Devices Division. 2, check the completeness of the material, meet the requirements of the admissibility of the bill issued, coded admissibility of the number of transfer to the audit process; does not meet the requirements, inadmissible. (B) audit 1, standards: "supervision and management of medical devices regulations", "Medical Device Registration Regulations", "Medical Device Manufacturer Quality System Assessment Measures", "Medical Device Specification Management Regulations", "Medical Device Standards Management" (for trial), "Interim Provisions for Clinical Verification of Medical Device Products" and related working documents, national standards, industry standards and other provisions. 2, according to the relevant national laws, regulations, regulatory documents and related standards, etc., the applicant to provide information for the form of review, sign the initial review opinion, meet the relevant requirements, put forward processing opinions; does not meet the relevant requirements, put forward to inform the applicant to supplement the information or rectification of the specific recommendations. Into the review process. (C) review 1, standards: "Supervision and Administration of Medical Devices Regulations", "Measures for the Administration of Registration of Medical Devices", "Measures for the Assessment of Quality System of Medical Device Manufacturing Enterprises", "Regulations for the Administration of Medical Devices Specifications", "Medical Devices Standards Administration" (for trial), "Interim Provisions for Clinical Verification of Medical Devices Products" and related working documents, national standards, industry standards and other provisions. 2, review the audit information and put forward processing opinions. (D) validation 1, standards: "Supervision and Administration of Medical Devices Regulations", "Measures for the Administration of Registration of Medical Devices", "Quality System Assessment Measures for Medical Device Manufacturers", "Medical Device Specification Management Regulations", "Medical Device Standards Management Regulations" (for trial implementation), "Interim Provisions for Clinical Verification of Medical Devices" and related working documents, national standards, industry standards and other provisions. 2、Issue medical device product registration certificate. (E) issuance of certificates, archiving Printing of medical device registration certificate sent to the Office of the acceptance of the registration information is organized and archived; does not meet the requirements of the "Measures for the Administration of Medical Device Registration", not to be issued, and explain the reasons in writing; make a decision not to issue a license, the applicant should be informed of the right to enjoy the right to administrative reconsideration according to law or to file an administrative lawsuit. Note: The registration application information in the provincial bureau at the same time, must be informed of the location of the municipal bureau for the record.