1 Classification and management of medical devices and regulatory authorities 2 Class I medical device filing application materials 1. Class I medical device filing form 2. Associated documents (1) the domestic filer to provide: Copy of the business license or institutional legal person certificate. Entrusted to other enterprises to produce, should provide the entrusted enterprise qualification documents (copy of business license), commissioning contracts and quality agreements. (2) overseas filers to provide: 1 overseas filers business qualification documents: overseas filers registered in the country (region) or the competent authority for the registration of medical devices issued by the competent authorities to prove that the overseas filers survive and have the appropriate medical device production qualification documents; or third-party certification bodies for the overseas filers issued by the overseas filers to prove that the overseas filers have the appropriate medical device production qualification documents. Medical device production qualification documents. 2 overseas filers registered or production address of the country (region) where the medical device authorities issued by the authorization of the product marketing documents. The filer's place of registration or production address in the country (region) is not the product as a medical device management, the filer is required to provide relevant documents, including the filer's place of registration or production in the country (region) permits the product to be marketed and sold documents. Not in the overseas filer's place of registration or production in the country (region) listed on the innovative medical devices can not be submitted. 3 overseas filers in China to designate the agent's power of attorney, the agent's statement of commitment, a copy of the agent's business license. 3. Product Technical Requirements Product technical requirements should be prepared in accordance with the "Guiding Principles for the Preparation of Technical Requirements for Medical Devices", including the finished product of the medical device can be objectively determined by the functionality, safety indicators and testing methods. 4. Product inspection report The product inspection report should be the full performance of the product self-inspection report or commissioned inspection report, inspection of the product should be typical. 5. Product specifications and minimum sales unit design samples Instructions and instructions should be consistent with the "medical device specifications and management regulations" of the relevant requirements, the performance of the product specifications should be consistent with the corresponding content of the product technical requirements. Imported products should be submitted to the competent government departments outside the approval or recognition of the original manual and its Chinese translation. 6. Manufacturing information on the production process is summarized. Passive medical devices should be clear product production and processing technology, indicating the key processes and special processes. Active medical devices should provide descriptive information on the production process, can be used in the form of flow charts, is an overview of the production process. In vitro diagnostic reagents should outline the main production process, including: solid-phase carrier, color development system and other descriptions and determine the basis for the reaction system, including sample collection and processing, sample requirements, sample dosage, reagent dosage, reaction conditions, calibration methods (if necessary), quality control methods. The actual situation of the development and production site should be summarized. Commissioned by other enterprises to produce, should list the commissioned enterprise name, residence, production address. 7. Declaration of conformity (1) Declaration of conformity with the first class medical device record requirements. (2) The statement that the product meets the requirements of the relevant classification and the basis, including "Class I Medical Device Directory" or "In Vitro Diagnostic Reagent Classification Subdirectory" of the relevant content. (3) Declare that the product meets the current national standards, industry standards and provide a list of standards. (4) Declaration of the authenticity of the information submitted for the record. 8. Other information (if necessary) "09-02-03 physical cooling equipment" for the record, in addition to the aforementioned information for the record, but also need to provide test information to prove that the product for the record can be achieved for the human body to cool down the role of the role of the (cold storage effect). 3 Class II medical device registration application materials 1. Application form for registration of medical devices in the territory 2. Proof of qualification including a copy of the business license, and the product should be applied for in the production of enterprise license within the scope of production approved 3. Product technical requirements at least should include the technical specifications or the main performance requirements of the determination of the basis of the content. 4. Safety Risk Analysis Report Prepared in accordance with the "Medical Device Risk Analysis" standard requirements. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and by the failure of function, poor maintenance and aging caused by the hazards of the five aspects of the analysis and the corresponding precautionary measures 5. Applicable product standards and descriptions The use of national standards, industry standards as the applicable standards of the product should be submitted to the national standards adopted by the national standards, industry standards of the text; the registration of product standards should be signed by the manufacturer. Standards should be signed by the manufacturer. Producers should provide the application for products in line with national standards, industry standards, the statement of the producer to assume responsibility for the quality of the products listed on the statement as well as the relevant product models, specifications and division of the description 6. Product performance self-test report Self-test of product performance for the registration of the product standards for the factory testing program, there should be a principal inspector or the person in charge of the main inspection, the reviewer's signature. Implementation of national standards, industry standards, the manufacturer should be supplemented with self-defined factory test items 7. Medical device testing organizations issued by the product registration test report Need to conduct clinical trials of medical devices, should be submitted to the clinical trial within six months before the start of the test report issued by the medical device testing organizations. 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 organizations. 8. Clinical trials of medical devices (if necessary) 9. Medical device specification The applicant to submit the medical device specification should be in line with the "medical device specification, and packaging labeling regulations. 10. Product production quality system assessment (certification) of the validity of the documents (1) provincial (food) drug supervision and management departments signed, within the validity period of the quality system assessment report (2) medical device production quality management standard inspection report or quality system certification of medical devices (3) The state has implemented the implementation of the rules of the production, the implementation of the rules to submit The implementation of the rules of inspection and acceptance report 11. The applicant should be submitted to the authenticity of the materials submitted by the self-assurance statement should include a list of materials submitted to the manufacturer to assume legal responsibility for the commitment. 12. The applicant is not the legal representative or person in charge of himself, the enterprise should submit a "power of attorney" 2 copies 4 Class III medical device registration application materials 1. Application for registration of medical devices 2. Medical device manufacturer qualification certificates (1) a copy of the manufacturer's license and a copy of the business license and stamped the certificate belongs to The official seal of the enterprise. (2) The application should be in the production of products approved by the manufacturer's license within the scope of production. (3) Within the validity period. 3. Product technical reports (should be stamped with the official seal of the manufacturer) 4. Safety risk analysis report (should be stamped with the official seal of the manufacturer) 5. Applicable product standards and instructions (1) standard text, should be stamped with the official seal of the manufacturer. (2) Preparation instructions (applicable to registered product standards). (3) Declaration of the product should be included in the scope of the product standard. (4) the use of national standards, industry standards as the applicable standards of the product: 1 producers should provide the application of the product in line with national standards, industry standards, and stamped with the official seal of the producer; 2 producers to bear the responsibility for the quality of the product on the market after the statement, and stamped with the official seal of the producer; 3 producers of relevant product models, specifications, and the division of the instructions 4.2.1.1.1 The product is not a product of the company, but a product of the company, and the official seal of the production company. 6. Product performance self-test report (1) There should be a principal inspector or principal inspector in charge, the auditor's signature, and stamped with the official seal of the manufacturer. (2) the implementation of national standards, industry standards, the manufacturer should be supplemented with self-defined factory test items, and stamped with the official seal of the manufacturer. 7. Medical device testing organizations issued by the product registration test report (1) The specifications of the product should be tested within the scope of the application for registration. (2) The type of test should be registered test or full performance of the national supervision and testing. (3) Original. (4) Within the validity period. 8. Clinical trials of medical devices (1) The manufacturer should be more than two (including two) "medical device clinical trial organization" for clinical trials. (2) The clinical trial data should include clinical trial contract, clinical trial program, clinical trial report: 1 clinical trial contract should be undertaken by the clinical trial of the medical institution and the implementation of the signature and seal; 2 clinical trial program should be the Ethics Committee, the clinical trial of the medical institution and the implementation of the seal; 3 clinical trial report should be the clinical trial The person in charge of clinical trials and clinical trials signed and confirmed by the competent authority of the test seal. 9. Medical device instructions: should provide instructions and stamped with the official seal of the manufacturer; omitted instructions, should be issued by the manufacturer to explain the document, and stamped with the official seal of the manufacturer. 10. Product production quality system assessment (certification) of the validity of the documents (1) provinces, autonomous regions and municipalities directly under the Central Drug Administration signed; if the medical device quality system certification can provide a copy of the certificate, but should be stamped with the certificate belongs to the company's official seal (2) within the validity period (3) the system covers the declaration of the product 11. The authenticity of the submitted materials Self-assurance statement (1) the list of materials submitted; (2) the commitment of the manufacturer to assume legal responsibility; (3) stamped with the official seal of the manufacturer. 12. Application materials (focusing on clinical trial reports) and verification reports on the authenticity of the sample production process.
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