Hello, you want to apply for the second class since the device registration certificate? The following is the relevant provisions of Guangdong Province, you can use as a reference
Administrative licensing conditions
1, the declaration of registration of the product has been included in the "Classification of Medical Devices Catalog", and the management of the category of the second class. (Note: For newly developed medical devices not yet included in the Classification Catalog, the applicant can apply directly to the State Food and Drug Administration
Administration of the third class of medical device product registration, but also based on the classification rules to determine the product category and apply to the State Food and Drug Administration for confirmation of the category, then apply for product registration or for product filing.)
2, the applicant should be in the jurisdiction of Guangdong Province in accordance with the law for the registration of enterprises.
3, the applicant to establish a quality management system related to product development, production, and maintain effective operation. Application for registration samples shall not be entrusted to other enterprises, except for products approved in accordance with the special approval procedures for innovative medical devices.
4, for the registration of medical devices should have the appropriate professional knowledge, familiar with the medical device registration or record management of laws, rules, regulations and technical requirements.
5, the applicant to apply for registration, should follow the basic requirements for the safety and effectiveness of medical devices, to ensure that the development process is standardized, all the data is true, complete and traceable.
6, the application for registration of information should be used in Chinese. According to the translation of foreign language information should be provided at the same time the original. Citation of unpublished literature, should provide the data owner permission to use the supporting documents. The applicant is responsible for the authenticity of the information.
7, the application is in line with the "Regulations for the Registration of Medical Devices". Declaration of materials by the technical review body technical review, in line with the safety and efficacy requirements.
8, for the accepted application for registration, one of the following circumstances, the food and drug supervision and management department to make a decision not to register, and inform the applicant:
(1) the applicant on the proposed market sales of medical devices for the safety and efficacy of the study and its results can not prove that the product safety, effective;
(2) registration of the declaration of information is false;< /p>
(3) the registration declaration information is confusing and contradictory;
(4) the content of the registration declaration information and the declaration of the project is obviously inconsistent;
(5) not registered in other cases.
Six, the application materials catalog
Registration filing information should be submitted information catalog, including the filing information of the first and second level headings. Each secondary title corresponding to the information should be prepared separately. The information should be prepared in accordance with the "Requirements for the Registration of Medical Devices Declaration Information", the specific requirements are as follows:
(1) Application Form
(2) Supporting Documents
Domestic applicants should submit:
(1) a copy of the business license copy 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 the production of other enterprises, should be provided with the production license of the entrusted enterprise and commissioning agreement. Production license production scope should cover the declared product categories.
(C) the list of basic requirements for the safety and effectiveness of medical devices
States that the product meets the "List of Basic Requirements for the Safety and Effectiveness of Medical Devices" (see application forms and documents to download) 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" in the non-applicable 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.
(D) synthesize the information
1. Overview
Describe the management category of the declared product, classification code and the basis for determining the name.
2. Product description
(1) passive medical devices
Description of the product's working principle, mechanism of action (if applicable), structural composition (including the use of accessories), the main raw materials, as well as features that distinguish it from other products of the same type and so on; if necessary, to provide graphic illustrations.
(2) active medical devices
Describe the product's working principle, mechanism (if applicable), structural composition (including accessories used in conjunction), the main function and its components (key components and software) function, as well as features that distinguish it from other similar products; if necessary, provide illustrations.
3. Model specifications
For the existence of a variety of model specifications of the product, should make clear 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 of the description.
4. Packaging instructions
Information about the product packaging, as well as with the product sold together with the packaging of accessories; for sterile medical devices, should be described with the sterilization method appropriate to the initial packaging information.
5. Scope of application and contraindications
(1)
Scope of application: it should be made clear that the treatment, diagnosis, etc. provided by the product is in line with the purpose as defined in Article 76 of the "Regulations for Supervision and Administration of Medical Devices", and the applicable medical stage (e.g., post-treatment monitoring, rehabilitation, etc.) can be described;
definition of the target users and their operation of the product should possess skills/knowledge/training; state whether the product is single-use or reusable; and describe the devices that are expected to be used in combination with it.
(2) Intended environment: the location where the product is intended to be used, e.g., medical facility, laboratory, ambulance, home, etc., and the environmental conditions (e.g., 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).
6. Reference to similar products or predecessor products should provide information on similar products (domestic and foreign marketed) or predecessor products (if any), describing the background and purpose of the research and development of the product for registration. 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 differences and similarities.
7. Other content to be described. For approved components or accessories used in conjunction with, 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 explain; should be described in the system of the combination of medical devices between the existence of physical, electrical and other means of connection.
(E) research information
Applicable research information according to the declared products.
1. Product performance research
Should provide product performance research information as well as 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 theoretical basis.
2. 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) the basis and methods of biocompatibility evaluation.
(2) a 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.
3. Biological safety studies
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In the case of products containing allogeneic materials, materials of animal origin or biologically active substances and other products with biosafety risks, should provide the relevant materials and biologically active 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 test
test; process validation of a brief summary.
4. Sterilization/disinfection process study
(1) Sterilization of the production company: should specify the sterilization process (methods and parameters) and the sterility assurance level (SAL), and provide sterilization confirmation report.
(2) end-user sterilization: it 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 tolerance research information.
(3) residual toxicity: such as sterilization methods used are prone to residue, should be clear residue information and treatment methods adopted, and provide research information.
(4) end-user disinfection: should specify the recommended disinfection process (methods and parameters) and the recommended disinfection methods to determine the basis.
5. Product validity and packaging research
(1) the determination of the validity period: if applicable, should provide a validation report on the product validity period.
(2) For a limited number of re-use of medical devices, the number of times of use should be provided to verify the information.
(3) packaging and packaging integrity: the basis for maintaining the integrity of the packaging within the declared expiration date and under the conditions of transportation and storage.
6. Pre-clinical animal testing
If applicable, should include the purpose of animal testing studies, results and records.
7. 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.
8. Other information
Proof of product safety, effectiveness of other research information.
(F) manufacturing information
1. Passive medical devices
Should be clear that the product production and processing technology, indicating the key processes and special processes, and explain their process control points. Define the use of various processing aids in the production process and the control of impurities (such as residual monomers, small molecule residues, etc.).
2. 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 "(F) manufacturing information" 1. 1. on the description of the production process information.
3. Production sites
Multiple development and production sites, should outline 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 provide the overseas government medical device authorities to approve the product on the market when the clinical evaluation information.
(H) 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. Traceability should be provided for each of the following processes for each of the identified hazards:
1. Risk analysis: including the scope of application of the medical device and safety-related features of the determination, the determination of the hazards, the estimated risk of each hazardous situation.
2. Risk Evaluation: For each determined hazard situation, evaluate and decide whether risk reduction is required.
3. The implementation of risk control measures and verify the results, if necessary, should be cited in the testing and evaluation reports, such as medical electrical safety, biological evaluation.
4. Acceptability ratings for any one or more residual risks.
(IX) 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.
(J) product registration inspection report
Provide medical device inspection qualification of medical device inspection organization 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
1. 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 provide a list of compliant standards.
2. Self-assurance statement of the authenticity of the submitted information (domestic products issued by the applicant, imported products issued by the applicant and agent respectively).
VII, application material requirements
(a) online declaration
In the written declaration submitted before the online declaration should be made through the enterprise online platform, "Medical Device Registration Certificate" issued by the electronic version of the application materials (online declaration of the Operational Guidelines.pdf), and upload the corresponding electronic documents. Obtain the pre-acceptance number and submit the written application within 1 month. Enterprises in the submission of paper application materials must be submitted at the same time the pre-acceptance number. The uploaded electronic documents include at least the following:
1. Application form.
2, product technical requirements. Should be a word document, and can be edited, modified. Should also submit a separate electronic document containing only the performance indicators of the technical requirements.
3, summary information. Should be word documents.
4, summary of research information. Should be a word document.
(2) Format and other requirements
1, the declaration should have a table of contents of the submitted information.
2. The filing information should be arranged in the order of the table of contents and bound in the order of cover, table of contents and filing information. The first page of each document for the label, or separated by tabbed divider, and according to the first level of directory marked with the item number. For details, see: information binding reference style.
3, a declaration of information, including the application form, product technical requirements in duplicate (one of which is bound with the other information, the other attached separately), should be printed on A4-size paper, the content is complete, clear, not altered, government departments and other organizations to provide the original size of the documents issued by the size of the original. Where a bound volume, shall not be split up by itself.
4, the declaration of information using photocopies, copies should be clear and consistent with the original.
5, the application content of the various declaration materials should be consistent.
6, the declaration of information should be stamped with the applicant's official seal.
7,
Packaged declaration of information in principle required to be sent by mail to the Guangdong Provincial Food and Drug Administration. If the applicant requested to send someone to the provincial business acceptance hall on-site acceptance of business, the handling personnel have been registered commissioner registration, can be registered
Ming directly for the relevant business, not registered commissioner registration, the handling personnel required to produce the applicant's authorization letter and the handling of the person's identity card original and a copy.