Second, the supporting documents
(1) Domestic applicants should submit:
1. Copy of business license and organization code certificate.
2. When applying for the registration of domestic medical devices in accordance with the procedures for examination and approval of the special license for innovative medical devices, a notice for examination of the application for special license for innovative medical devices shall be submitted. If the samples are entrusted to other enterprises for production, the production license and entrustment agreement of the entrusted enterprise shall be provided. The production scope of the production license shall cover the declared product categories.
(2) Overseas applicants shall submit:
1. Certification documents issued by the competent department of medical devices in the country (region) where the overseas applicant is registered or the place where the production address is located, and certification documents of enterprise qualification.
2. If the product is not managed as a medical device in the country (region) where the overseas applicant is registered or the production address is located, the applicant shall provide relevant certification documents, including certification documents allowing the product to be listed in the country (region) where the registration place or the production address is located.
3. A copy of the power of attorney, the letter of commitment of the agent and the business license or institution registration certificate of the overseas applicant's designated agent in China.
Three. List of basic requirements for safe and effective medical devices
Explain the methods used by the product to meet the applicable requirements of the List of Safe and Effective Basic Requirements for Medical Devices (see Annex 8), and the documents proving its compliance. If the requirements in the List of Basic Requirements for Safe and Effective Medical Devices are not applicable, the reasons shall be explained.
The documents contained in the application materials for product registration shall indicate the specific location in the application materials; For the documents not included in the application materials for product registration, the name and number of the evidence documents in the quality management system documents shall be indicated for future reference.
Fourth, summarize the information
(1) Overview
Describe the management category, classification code and name determination basis of the declared product.
(2) Product description
1. Passive medical equipment
Describe its working principle, mechanism of action (if applicable), structural composition (including accessories), main raw materials and characteristics different from other similar products; Provide illustrations when necessary.
2. Active medical equipment
Describe the working principle, action mechanism (if applicable), structural composition (including supporting accessories), main functions and functions of its components (key components and software), as well as the characteristics different from other similar products. Provide illustrations when necessary.
(3) Model and specification
For products with multiple models and specifications, the differences between models and specifications should be made clear. The comparison table, pictures and charts with explanatory text shall be used to describe the structural composition (or configuration), functions, product features, operation modes and performance indicators of various models and specifications.
(4) packing instructions
Information about product packaging and accessory packaging sold with the product; For sterile medical devices, the initial packaging information applicable to sterilization methods should be explained.
(5) Scope of application and contraindications
1. Scope of application: it should be clear that the treatment and diagnosis provided by the product meet the purpose stipulated in Article 76 of the Regulations on the Supervision and Administration of Medical Devices, and can describe the applicable medical stages (such as post-treatment monitoring and rehabilitation); Determine the target users and the skills/knowledge/training they should have when operating the products; State whether the product is disposable or reusable; Describe the device to be combined with.
2. Expected use environment: places where the product is expected to be used, such as medical institutions, laboratories, ambulances, homes, etc. And environmental conditions (such as temperature, humidity, power, pressure, movement, etc.) that may affect its safety and effectiveness. ).
3. Applicable population: information of target patient population (such as adults, children or newborns), information of patient selection criteria, parameters to be monitored and factors to be considered when using.
4. Contraindications: If applicable, certain diseases, conditions or specific groups (such as children, the elderly, pregnant women and lactating women, and people with liver and renal insufficiency) that the device is not suitable for should be clearly stated.
(6) References of similar products or previous generation products shall provide information of similar products (listed at home and abroad) or previous generation products (if any), and explain the research and development background and purpose of the products applied for registration. For similar products, the reasons for choosing them as R&D reference should be explained.
At the same time, compare the similarities and differences between this product and reference products (similar products or previous products) in working principle, structural composition, manufacturing materials, performance indicators, modes of action (such as implantation and intervention), scope of application and so on.
(seven) other contents that need to be explained. If the approved parts or accessories are used together, the approval number and a copy of the approval document shall be provided; If it is expected to be used jointly with other medical devices or general products, an explanation shall be provided; The physical and electrical connection modes between combined medical devices in the system should be explained.
Verb (abbreviation of verb) research data
Provide applicable research materials according to the declared products.
(A) product performance research
The research data of product performance and the research and compilation description of product technical requirements shall be provided, including the basis for determining functional and safety indicators (such as electrical safety and electromagnetic compatibility, radiation safety) and other indicators related to quality control, the standards or methods adopted, the reasons and theoretical basis adopted.
(2) Study on biocompatibility evaluation.
The biocompatibility of materials in the finished product that are in direct or indirect contact with patients and users should be evaluated.
Biocompatibility evaluation research data should include:
1. Basis and method of biocompatibility evaluation.
2. Description of the materials used in the product and the nature of contact with human body.
3 reasons and arguments for implementing or exempting biological experiments.
4. Evaluation of existing data or test results.
(3) Biosafety research
For products with biosafety risks such as allogenic materials, animal-derived materials or bioactive substances, the biosafety research data of related materials and bioactive substances should be provided. Including the acquisition, processing, preservation, testing and treatment of tissues, cells and materials; Explain the source (including the details of donor screening), and describe the verification test of the removal or inactivation methods of viruses, other pathogens and immunogenic substances in the production process; A brief summary of process verification.
(4) Study on sterilization/disinfection technology.
1. Sterilization of production enterprises: The sterilization process (method and parameters) and sterility assurance level (SAL) shall be defined, and the sterilization confirmation report shall be provided.
2. End-user sterilization: the recommended sterilization process (method and parameters) and the basis for determining the recommended sterilization method should be clearly defined; For products that can withstand two or more times of sterilization, research data on the tolerance of recommended sterilization methods related to the product should be provided.
3. Residual toxicity: If the sterilization method is easy to produce residues, the residual information and treatment methods should be clarified, and research data should be provided.
4. End-user disinfection: the recommended disinfection process (methods and parameters) and the basis for determining the recommended disinfection method should be clearly defined.
(5) Study the shelf life and packaging of products.
1. Determination of expiry date: If applicable, a verification report on the expiry date of the product shall be provided.
2. For medical devices with limited reuse times, the verification data of the use times shall be provided.
3. Packaging and packaging integrity: the basis for maintaining packaging integrity within the declared validity period and under transportation and storage conditions.
(6) Preclinical animal tests
If applicable, it should include the purpose, results and records of animal experimental research.
(vii) Software research
For products containing software, a separate medical device software description document should be provided, including basic information, implementation process and core algorithm. The level of detail depends on the security level and complexity of the software. At the same time, a statement on the naming rules of software versions should be issued, all fields and field meanings of software versions should be clarified, and the complete version of the software and the identification version used for distribution should be determined.
(8) Other information.
Other research data to prove the safety and effectiveness of the product.
Intransitive verbs make information
(1) Passive medical equipment
The production and processing technology of products should be defined, the key technology and special technology should be indicated, and the process control points should be explained. Clarify the use of various processing AIDS and the control of impurities in the production process (such as residual monomers and small molecular residues, etc.). ).
(2) Active medical devices
The process flow of product production should be defined, which can be in the form of flow chart, and its process control points should be explained.
Note: Some active medical devices (such as pacemakers and leads) should pay attention to the description of production process information in "VI". Manufacturing information "(I).
(3) the production site
If there are multiple scientific research and production sites, the actual situation of each scientific research and production site should be summarized.
Seven, clinical evaluation data
Submit clinical evaluation data in accordance with relevant regulations. When the competent department of medical devices of overseas governments approves the marketing of products, the imported medical devices shall provide clinical evaluation data.
Eight, product risk analysis data
Product risk analysis data is data formed by recording product risk management process and its review results. Traceability of each of the following processes shall be provided for each identified hazard:
(1) Risk analysis: including the determination of the scope of application and safety-related characteristics of medical devices, the determination of hazards and the risk assessment under various hazards.
(2) Risk assessment: evaluate each judged dangerous situation and decide whether it is necessary to reduce the risk.
(3) The implementation and verification results of risk control measures should be quoted in the test and evaluation report when necessary, such as medical electrical safety and biological evaluation.
(4) Acceptability assessment of any one or more residual risks.
Nine, product technical requirements
The technical requirements of medical device products shall be compiled in accordance with the provisions of the Guiding Principles for the Compilation of Technical Requirements of Medical Device Products. The technical requirements of the product are in duplicate, and two statements that the technical requirements of the product are completely consistent are submitted.
X. Product registration inspection report
Provide registration inspection reports and pre-evaluation opinions issued by medical device inspection institutions with medical device inspection qualifications.
Eleven, product specifications and minimum sales unit label samples.
Comply with the requirements of relevant laws and regulations.
Twelve. Declaration of conformity
(1) The applicant declares that the product meets the requirements of the Administrative Measures for the Registration of Medical Devices and relevant laws and regulations; Declare that the product meets the classification requirements of the Classification Rules for Medical Devices; Declare that this product conforms to the current national standards and industry standards, and provide a list of standards.
(2) Self-assurance statement on the authenticity of the submitted materials (domestic products are issued by the applicant, and imported products are issued by the applicant and the agent respectively).