Medical device registration Clarify all the fields of the software version and the meaning of the fields How to write

Application Form II, supporting documents (a) the domestic applicant shall submit: 1. A copy of the business license and a copy of the organization code certificate. 2. In accordance with the "Innovative Medical Devices Special Approval Procedures for Approval" of the domestic application for registration of medical devices should be submitted to the Innovative Medical Devices Special Approval Application Review Notification Form, samples entrusted to the production of other enterprises should provide the production of commissioned companies Production license and commissioning agreement. The scope of production license should cover the declared product categories. (B) overseas applicants should submit: 1. overseas applicants registered or production address of the country (region) where the competent medical device authority issued by the product is allowed to market documents, business qualifications. 2. overseas applicants registered or production address of the country (region) is not the product as a medical device management, the applicant is required to provide relevant documents, including registration or production address of the country (region) to allow the product to be marketed. Production address of the country (region) to allow the product marketing documents. 3. Overseas applicants in China to designate the agent's power of attorney, the agent's letter of commitment and a copy of the business license or a copy of the agency registration certificate. Third, the list of basic requirements for the safety and effectiveness of medical devices to indicate that the product meets the "List of Basic Requirements for the Safety and Effectiveness of Medical Devices" (see Annex 8) of the applicable requirements of the method used, as well as to prove its compliance with the documents. For the "List of Basic Requirements for the Safety and Effectiveness of Medical Devices" does not apply to the requirements, should explain the reasons. For the documents contained in the declaration of product registration information, should indicate its specific location in the declaration of information; for the documents not contained in the declaration of product registration information, should indicate the name of the evidence document and its quality management system in the document number for inspection. Fourth, the synthesis of information (a) Overview describes the management of the declared product categories, classification codes and the basis for determining the name. (B) product description 1. passive medical device description of the product's working principle, mechanism (if applicable), structural composition (including accessories for use), the main raw materials, as well as features that distinguish it from other similar products; if necessary, provide graphical illustrations. 2. active medical device description of the product's working principle, mechanism (if applicable), structural composition (including accessories for use), the main features And its components (key components and software) functions, as well as features that distinguish it from other similar products and so on; if necessary, provide illustrations. (C) model specifications for the existence of a variety of model specifications of the product, should be clear about the differences between the model specifications. Should be used to compare tables and pictures with explanatory text, charts, for a variety of models and specifications of the structural composition (or configuration), functionality, product features and operating modes, performance indicators and other aspects of the description. (D) packaging information about the product packaging, as well as packaging of accessories sold with the product; for sterile medical devices, should be described with the sterilization method appropriate to the initial packaging information. (E) Scope of application and contraindications 1. Scope of application: It should be clear that the treatment, diagnosis, etc. provided by the product meets the purposes defined in Article 76 of the Regulations for the Supervision and Administration of Medical Devices, and can describe the medical stage to which it applies (e.g., post-treatment monitoring, rehabilitation, etc.); it should be clear that the target user and the skills/knowledge/training he/she should have to operate the product; and it should indicate whether the product is a one-time use or a repeated use; A description of the device(s) with which it is expected to be used in combination.2. Intended environment of use: the location(s) where the product is expected to be used, such as healthcare facilities, laboratories, ambulances, homes, etc., and the environmental conditions that may affect its safety and efficacy (e.g., temperature, humidity, power, pressure, mobility, etc.).3. Applicable populations: information on the target patient populations (e.g., adults, children, or neonates), information on the criteria for selection of patients, the and parameters to be monitored during use, factors to be considered.4. Contraindications: if applicable, it should be clearly stated that the device is not suitable for the application of certain diseases, conditions or specific groups of people (such as children, the elderly, pregnant and lactating women, liver and kidney insufficiency). (F) reference to similar products or predecessor products should provide information on similar products (domestic and foreign marketed) or predecessor products (if any), describing the application for registration of the product's R & D background and purpose. For similar products, should explain the reasons for its selection as a reference for research and development. At the same time, a list of comparative description of the product and the reference product (similar products or predecessor products) in the working principle, structural composition, manufacturing materials, performance indicators, mode of action (such as implantation, intervention), as well as the scope of application and other aspects of the similarities and differences. (vii) Other content to be explained. For components that have been approved or with the use of accessories, should provide the approval number and a copy of the approval document; expected to be used in combination with other medical devices or generic products should be provided to illustrate; should explain the system of the combination of medical devices between the existence of physical, electrical and other means of connection. V. Research information according to the declared products, provide applicable research information. (A) product performance research should provide product performance research information and product technical requirements of the research and preparation of instructions, including functionality, safety indicators (such as electrical safety and electromagnetic compatibility, radiation safety) and other indicators related to quality control to determine the basis of the standards or methods used, the reasons for adoption and the theoretical basis. (ii) Biocompatibility evaluation study should evaluate the biocompatibility of materials in the finished product that are in direct or indirect contact with patients and users. Biocompatibility evaluation study information should include: 1. Biocompatibility evaluation of the basis and methods. 2. Description of the materials used in the product and the nature of contact with the human body. 3. Implementation or exemption from biological testing and justification. 4. Evaluation of the existing data or test results. (C) biological safety research for the inclusion of allogeneic materials, materials of animal origin or biological active substances and other products with biological safety risks, should provide relevant materials and biological active substances of biological safety research information. Including a description of the acquisition, processing, preservation, testing and handling of tissues, cells and materials; elaboration of the source (including details of donor screening), and describes the production process of viruses, other pathogens and immunogenic substances removed or inactivated method of validation tests; a brief summary of process validation. (D) Sterilization / disinfection process research 1. Sterilization of production companies: should specify the sterilization process (methods and parameters) and Sterility Assurance Level (SAL), and provide sterilization confirmation report. 2. end-user sterilization: should specify the recommended sterilization process (methods and parameters) and the recommended sterilization method to determine the basis; for products that can tolerate two or more times of sterilization, the product should be provided with the relevant recommended sterilization methods Residual toxicity: If the sterilization method is easy to residue, it should be clear that the residue information and take the treatment method, and provide research information. 4. end-user disinfection: It should be clear that the recommended disinfection process (methods and parameters) and the recommended disinfection method to determine the basis. (E) product expiration date and packaging research 1. Determination of the expiration date: If applicable, should provide a validation report on the expiration date of the product. 2. For a limited number of reuse of medical devices, the number of times the use of validation information should be provided. 3. Packaging and packaging integrity: in the claimed validity period as well as transportation and storage conditions, to maintain the integrity of the basis of the packaging. 4. (F) preclinical animal testing, if applicable, should include the purpose of animal testing studies, results and records. (G) software research products containing software, should provide a separate medical device software description document, including basic information, implementation process and core algorithms, the degree of detail depends on the level of security and complexity of the software. At the same time, should be issued on the software version of the naming rules of the statement, clear software version of all the fields and field meanings, to determine the full version of the software and the release of the logo version used. (H) other information to prove product safety, effectiveness of other research information. Sixth, the manufacturing information (a) passive medical devices should be clear product production and processing technology, indicating the key processes and special processes, and explain its process control points. Clearly the use of various processing aids in the production process and the control of impurities (such as residual monomers, small molecule residues, etc.). (B) active medical devices should be clear product production process, can be used in the form of flow charts, and explain its process control points. Note: Some active medical devices (eg: pacemakers and wires) should be noted to consider the use of "six, manufacturing information" (a) in the description of the production process information. (C) production sites have more than one development and production sites, should summarize the actual situation of each development and production sites. Seven, clinical evaluation information submitted in accordance with the appropriate provisions of the clinical evaluation information. Imported medical devices should be provided outside the government medical device authorities to approve the product listing of clinical evaluation information. Eight, product risk analysis information product risk analysis information is the product risk management process and the results of the review to be recorded in the information formed. Should be provided for each of the following processes have been determined the traceability of hazards: (a) risk analysis: including the scope of application of medical devices and safety-related features of the determination, the determination of hazards, the estimation of the risk of each hazardous situation. (ii) Risk evaluation: For each determined hazard situation, evaluate and decide whether risk reduction is required. (iii) The results of the implementation and validation of risk control measures, citing, where necessary, testing and evaluative reports, e.g., medical electrical safety, biological evaluations. (D) Any one or more residual risk acceptability assessment. Nine, product technical requirements for medical devices product technical requirements should be prepared in accordance with the provisions of the "Guidelines for the Preparation of Technical Requirements for Medical Device Products". Product technical requirements in duplicate, and submit two copies of the product technical requirements text is identical to the statement. Ten, the product registration inspection report to provide a medical device inspection qualification of medical device inspection organizations issued by the registration inspection report and pre-evaluation. XI, product specifications and minimum sales unit labeling samples should be consistent with relevant regulatory requirements. XII, Declaration of Conformity (a) the applicant declares that the product meets the "Measures for the Administration of Registration of Medical Devices" and relevant regulations; declares that the product meets the "Rules for the Classification of Medical Devices" related to the classification of requirements; declares that the product meets the current national standards, industry standards and provide a list of conformity with the standards. (B) the submitted information on the authenticity of the self-assurance statement (domestic products issued by the applicant, imported products issued by the applicant and agent respectively).