II. Supporting Documents
(a) The domestic applicant shall submit:
1. A copy of the business license of the enterprise and a copy of the organization code certificate.
2. In accordance with the "Special Approval Procedures for Innovative Medical Devices Approval" of the domestic medical device application for registration, should be submitted to the Special Approval of Innovative Medical Devices application for review of the notification form, samples entrusted to other enterprises to produce, should be provided with the production license of the entrusted enterprise and commissioning agreement. Production license production scope should cover the declared product categories.
(B) overseas applicants should submit:
1. overseas applicants registered or production address in the country (region) where the competent authority for medical devices to allow the product marketed and sold on the documents issued by the competent authority, the enterprise qualification documents.
2. Foreign applicants registered or production address of the country (region) is not the product as a medical device management, the applicant needs to provide relevant documents, including registration or 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 statement of commitment and a copy of the business license or a copy of the agency registration certificate.
Three, the list of basic requirements for the safety and efficacy of medical devices
Description of the product meets the "List of basic requirements for the safety and efficacy of medical devices" (see Annex 8) the applicable requirements of the method used, as well as to prove its conformity with the documents. For the List of Basic Requirements for the Safety and Effectiveness of Medical Devices not applicable 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.
Four, synthesize the information
(a) Overview
Describe the management category of the declared product, classification code and name of the basis for determining.
(B) product description
1. Passive medical devices
Describe the product's working principle, mechanism of action (if applicable), structural composition (including accessories used in conjunction with), the main raw materials, as well as the characteristics of the difference between other similar products and so on; if necessary, to provide graphic illustrations.
2. Active medical devices
Description of the product's working principle, mechanism (if applicable), structural composition (including accessories for use), the main function and its components (key components and software) function, as well as the characteristics of the difference between other similar products and so on; if necessary, provide graphic illustrations.
(C) model specifications
For the existence of a variety of model specifications of the product, it should be clear that the difference between the model specifications. Comparison table and pictures with explanatory text should be used, charts, for a variety of models and specifications of the structural composition (or configuration), functionality, product features and mode of operation, performance indicators and other aspects to describe.
(D) packaging instructions
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 is in line with 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.); clarify the target users and the skills/knowledge/training they should have to operate the product; state whether the product is for single use or repeated use; state that the product is single-use or reusable; describe the device(s) with which it is expected to be used in combination.
2. Intended environment: the location where the product is intended to be used, such as medical institutions, laboratories, ambulances, homes, etc., as well as the environmental conditions (eg, temperature, humidity, power, pressure, movement, etc.) that may affect its safety and effectiveness.
3. Applicable population: information on the target patient population (e.g., adults, children, or neonates), information on patient selection criteria, and parameters to be monitored and factors to be considered during use.
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 research and development background and purpose. For similar products, should explain the reasons for choosing it as a reference for research and development.
At the same time, a list of comparisons between the product and the reference product (similar products or predecessor products) in terms of 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 similarity and difference.
(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
Applicable research information is provided according to the declared product.
(A) product performance research
Should provide product performance research information and product technical requirements of the research and preparation of the description, including functionality, safety indicators (such as electrical safety and electromagnetic compatibility, radiation safety) and other indicators related to quality control based on the determination of the standards or methods used, the reasons for adoption and the theoretical basis.
(II) biocompatibility evaluation study
The biocompatibility of materials in the finished product that are in direct or indirect contact with patients and users should be evaluated.
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. Rationale and justification for implementing or exempting biological tests.
4. Evaluation of available data or test results.
(C) biosafety research
For products containing allogeneic materials, animal-derived materials or bioactive substances and other products with biosafety risks, should provide the relevant materials and bioactive substances biosafety 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.
(iv) Sterilization/disinfection process study
1. Sterilization of the production company: the sterilization process (methods and parameters) and the level of sterility assurance (sal) should be clarified, and provide a report on sterilization confirmation.
2. End-user sterilization: should be clear that the recommended sterilization process (methods and parameters) and the recommended sterilization method to determine the basis; can withstand two or more sterilization of the product, it should provide the product related to the recommended sterilization method of tolerance of the research data.
3. Residual toxicity: such as sterilization methods used in easy residue, should be clear information on the residue and take the treatment method, and provide research information.
4. end-user disinfection: should be clear that the recommended disinfection process (methods and parameters) and the recommended disinfection methods to determine the basis.
(E) product validity and packaging research
1. Determination of the expiration date: If applicable, should provide a validation report on the product expiration date.
2. For a limited number of re-use of medical devices, the number of uses should be provided to verify the information.
3. Packaging and packaging integrity: in the claimed expiration date and transportation and storage conditions, the basis for maintaining the integrity of packaging.
(F) preclinical animal testing
If applicable, should include the purpose of animal testing studies, results and records.
(VII) 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 the meaning of the fields, to determine the full version of the software and distribution of the identification version used.
(H) other information
Proof of product safety, effectiveness of other research information.
VI, manufacturing information
(a) passive medical devices
should be clear that the product production and processing processes, indicating the key processes and special processes, and explain their process control points. Specify 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 that the 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
Multiple development and production sites, should summarize the actual situation of each development and production sites.
VII, 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.
VIII, product risk analysis
Product risk analysis information is the product risk management process and the results of the review to be recorded in the information formed. Should provide traceability for each of the following processes have been determined hazards:
(a) Risk analysis: including the scope of application of medical devices and safety-related features of the determination, the determination of hazards, the estimated risk of each hazardous situation.
(ii) Risk evaluation: for each determined hazard situation, evaluate and decide whether risk reduction is required.
(c) the implementation of risk control measures and verify the results, if necessary, should be cited testing and evaluation reports, such as medical electrical safety, biological evaluation.
(iv) Acceptability ratings for any one or more residual risks.
Nine, product technical requirements
Medical device product technical requirements should be prepared in accordance with 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
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 meet the relevant regulatory requirements.
XII, Declaration of Conformity
(a) The applicant declares that the product complies with the "Measures for the Administration of Registration of Medical Devices" and relevant regulations; declares that the product complies with the "Rules for the Classification of Medical Devices" related to the classification of the requirements; declares that the product complies with the current national standards, industry standards, and provides a list of compliant standards.
(ii) 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).