Class II medical device registration

A, conditions:

1) the declaration of registration of the product has been included in the "Classification of Medical Devices Catalog", and the management category for the second class. (Note: the newly developed medical devices have not been included in the classification of the catalog, the applicant can directly to the State Food and Drug Administration to apply for registration of Class III medical device products, can also be based on the classification rules to determine the product category and to the State Food and Drug Administration to apply for confirmation of the category, apply for product registration or for the product record.)

2) The applicant should be registered in the provincial jurisdiction according to law.

3) The applicant to establish a quality management system related to product development, production, and maintain effective operation. Application for registration of samples shall not be entrusted to other enterprises to produce, in accordance with the special approval procedures for innovative medical devices, except for the approval of the product.

4) for the registration of medical devices should have the appropriate professional knowledge, familiar with the registration of medical devices or record management of laws, rules, regulations and technical requirements, such as: "Supervision and Administration of Medical Devices Regulations", "Registration of Medical Devices", "Classification of Medical Devices Rules", "on the further improvement of the work of product classification of medical devices to define the notice", "on the release of medical device product technical requirements preparation guidelines. Notice on Issuing Guidelines for Preparation of Technical Requirements for Medical Device Products", "Provisions on Clinical Trials of Medical Devices", "Technical Guidelines for Clinical Evaluation of Medical Devices", "Provisions on Specification and Management of Medical Devices", "Notice on Matters Relating to the Implementation of Measures for the Administration of Registration of Medical Devices and Measures for the Administration of In Vitro Diagnostic Reagents" by the General Administration of Food and Drug Administration, "Announcement on the Requirements for Declaration of Registration Information and Format of Approval Document of Medical Device and the announcement of the format of the approval of documents," and so on.

5)Applicants applying for registration should follow the basic requirements for the safety and effectiveness of medical devices, to ensure that the development process is standardized, and all data are true, complete and traceable.

6) Application for registration 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 owner of the information should be allowed to use the documents. The applicant is responsible for the authenticity of the information.

Second, the required materials:

(a) the application materials catalog

1. application form (in duplicate, one of which is bound with other information, a separate attached)

2. supporting documents

3. list of basic requirements for the safety and efficacy of medical devices

4. overview of the information:

Overview

Product description

Model specifications

Packaging Description

Scope of application and contraindications

Reference to similar products or predecessor products (if any)

Other content to be described

5. Research information:

Product performance studies

Biocompatibility evaluation studies

Biosafety studies

Sterilization and disinfection process studies

Expiry date and packaging studies

Animal studies

Other

6. Manufacturing information

passive products / active products production process information description

production sites

7. Clinical evaluation information

8. Product risk analysis information

9. Product technical requirements (in duplicate, of which one original bound book, a copy of a separate enclosure)

10. Product registration and inspection reports Product registration test report 11. Instructions and samples 12. Declaration of conformity (B) the application materials form standards 1. Declaration of information should be submitted to the table of contents, including the declaration of information on the first and second level of the title. Each secondary title corresponding to the information should be prepared separately page number.

2. Declaration of information in a single copy, should be arranged in the order of the catalog and bound. Application form, product technical requirements in duplicate, one of which does not need to be bound into a booklet, provided separately, accompanied by two copies of the text of the statement of complete consistency.

3. Declaration of information should be printed on A4-size paper, complete and clear, without alteration, government departments and other organizations issued by the original size of the document provided. Where the bound volume, not split.

4. Declaration of the use of photocopies of information, copies should be clear and consistent with the original.

5. The application content of the declarations should be consistent.

6. The declaration should be stamped with the applicant's official seal.

7. Registration and declaration of information should also be submitted at the same time the following electronic documents: (a) application form. (b) product technical requirements. Should be word documents, and can be edited, modified. Should also be submitted to a separate electronic document containing only the performance indicators part of the technical requirements. (c) review information, research data summary. Should be a word document. (d) other electronic documents to declare information.

(C) the specific requirements of the application materials

(1) application form

1. Strictly in accordance with the requirements for filling out the form, through the system to fill out the online printout, the legal representative or person in charge of signing and stamping;

2. Application form must be accompanied by a written "Product Classification Basis" of the direct evidence of the material should be consistent with the following One of the requirements

1) "Medical Device Classification Catalog (2002 Edition)" corresponding sub-catalog "name examples" of the page;

2) the State Food and Drug Administration issued for the classification of the product definition of the notification document, and conspicuously marked with the corresponding terms;

3) through the classification system to define the printout of the "Medical Device Product Classification Definition Application Notice";

3. 3. Non-paperless declaration, the application form to provide two copies, one of which is not required to bind the book, provided separately.

4. The application form should be attached to the table of contents of the submitted materials, including the first and second level headings of the declaration. Each secondary title corresponding to the information should be prepared separately page number.

(2) supporting documents

Domestic applicants should submit:

(a) a copy of the business license and a copy of the organization code certificate.

(b) In accordance with the "innovative medical device special approval procedures for approval" of the domestic application for registration of medical devices, innovative medical devices should be submitted to the special approval of the application for review of the notification form, samples entrusted to other enterprises to produce, should be provided with the entrusted enterprise production license and commissioning agreement. The production license should cover the production scope of the declared product categories.

(3) 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 the application form and documents to download) 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" does not apply to the requirements, should explain the reasons.

For product registration is included in the declaration of information in the document, it should be stated in the declaration of information in the specific location; for product registration is not included in the declaration of information in the document, it should be noted that the name of the evidence document and its quality management system in the document number for inspection.

(4) Overview of the information

1. Overview

Description of the declaration of the product management category, classification code and name of the basis for determining.

2. Product description

(1) passive medical devices

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 and so on; if necessary, provide illustrations.

(2) active medical devices

Description of the product's operating principle, mechanism (if applicable), structural components (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 graphical illustrations.

3. 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. Should be used to compare tables and pictures with explanatory text, charts and graphs, for a variety of models and specifications of the structural composition (or configuration), functionality, product features and operating modes, performance indicators and other aspects to be described.

4. Packaging

information about the product packaging, as well as the product with the sale of accessories packaging; 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 clear that the product provides treatment, diagnosis, etc. in line with the "supervision and management of medical devices regulations" defined in Article 76 of the purpose, and can be described as applicable to the medical stage (eg, post-treatment monitoring, rehabilitation, etc.); a clear target user and its operation of the product should have the skills/knowledge/training; that the product is a one-time use or reusable; state the devices that are expected to be used in combination with it.

(2) the intended environment: the product is intended to be used in places such as medical institutions, laboratories, ambulances, homes, etc., as well as 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., ****, children, or newborns), information on patient selection criteria, and parameters to be monitored and factors to be considered during use.

(4) Contraindications: If applicable, the device should be clearly stated that it 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, it 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 the principle of operation, structural composition, manufacturing materials, performance indicators, mode of action (such as implantation, intervention), as well as the scope of application and so on, the similarities and differences.

7. Other content to be described. For the approved components 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 explain; should be described in the system of the combination of medical devices between the existence of physical, electrical and other means of connection.

(5) research information

According to the declared products, provide applicable research information.

1. 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 to determine the basis of the standards or methods used, the reasons for the use and the 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) biocompatibility evaluation basis and methodology.

(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.

3. Biosafety research

For the inclusion of allogeneic materials, materials of animal origin or bioactive substances and other biosafety risk products, should provide the relevant materials and bioactive substances of biological safety research information. Including descriptions of tissues, cells and materials to obtain, processing, preservation, testing and handling; describe the source (including donor screening details), and describe the production process of viruses, other pathogens and immunogenic substances removed or inactivated method of verification tests; process verification of a brief summary.

4. Sterilization/disinfection process study

(1) Sterilization of the manufacturer: should specify the sterilization process (methods and parameters) and sterility assurance level (SAL), and provide a 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; for products that can withstand two or more sterilizations.