Class II medical device registration certificate for

The second class medical device registration certificate for the process, the details are as follows:

First, the medical device application materials directory:

1, application form for registration of medical devices;

2, the medical device manufacturer qualification certificate;

3, the product technical reports;

4, safety risk analysis report;

5, the applicable product standards and descriptions; (should have the testing organization) Signature)

6, product performance self-test report;

7, qualified medical device testing organizations issued by the product registration test report; (original)

8, medical device clinical trial information; (original, the specific submission method see "Registration Management" Annex 12)

9, medical device instructions;

10, the product production quality system assessment (certification) Effective documentation; (original) Data No.

11, the authenticity of the materials submitted to the self-assurance statement.

Second, the medical device application requirements:

(a) the general requirements of the reporting information:

1, the format requirements:

(1) application materials should be consistent with the filling of the same project;

(2) application materials should be printed on A4 specification paper;

(3) the application materials should be clear, neat, each application material should be bound and stamped with the official seal of the enterprise, and in accordance with the order of the directory of application materials bound into the Application materials in the order of the directory bound into a book;

(4) in the first page of each document for a label, or separated by tabbed divider, and marked with the project number;

(5) with a file bag will be submitted to the materials packed, the file bag need to use the cover (see the format of the "File Bag Cover Format.doc"), in the bag surface Mark the name of the manufacturer, address, product name, contact person and telephone, and add the application materials to review the medical device registration application personnel name (signature), contact information, such as medical device registration commissioner please provide the name (signature), contact information and filing certificate number.

2, the application form for registration of medical devices, product standards in duplicate, and other information a copy. (Annex 1 to Annex 5 attached, without binding with the entire set of application materials)

3, the (listed approvals, standards, test reports, manuals) declaration of the product name should be filled out in the application form with the product name of the substantive content corresponds to. If there is a trade name, the trade name should be labeled. Declaration of information should be used in Chinese, according to foreign language data translation of the declaration of information, should be provided at the same time the original.

4, the declaration of information accepted, the enterprise shall not apply for supplemental, but belongs to the "Registration of Medical Devices Management Measures" Article 38 of the circumstances, you can apply for supplemental.

5, the manufacturer in the submission of registration information, should be submitted at the same time the application form for registration of medical devices, product registration standards and filing instructions, labels and packaging identification of the electronic text (Word format, the specific requirements of the "on the adjustment of the content of the medical device specification for the record notification" (Food and Drug Administration Office [2008] No. 125), the content of its content must be consistent with the content of the paper documents. Electronic text can be submitted through a mobile storage device (U disk or CD-ROM) form.

6, for the application for registration of medical devices should be entrusted by the production company, should be submitted to the production company responsible for the original identity card and a copy (production company for the person in charge); or production companies issued by the enterprise registration application for the authorization of the staff for the application of affairs and the person for the identity of the original identity card and a copy of the copy (non-production company for the person in charge), the original identity card after verification. Return.

7, such as an application in line with the State Food and Drug Administration, "Registration of Medical Devices Management Measures" in the relevant exemptions, or in line with the provisions of the State Bureau of other relevant documents, should be submitted to the appropriate documents.

8, this guide has been clearly required to submit the original, shall not be submitted to the copy. Where the application materials need to submit a copy of the applicant (unit) must be indicated on the copy of the "copy of the original and the original in line with the" words or text, indicate the date, stamped with the official seal of the unit. Note 1: Enterprises should keep a copy of the registration information for registration verification. (If the registration application is not approved, the entire set of registration information is not refundable, the applicant can apply for a copy of the original back.)

(B) the specific requirements of the reporting information:

1, medical device registration application form

(1) should be signed by the legal representative and stamped with the official seal, fill in the items should be complete and accurate;

(2) "Manufacturer's name", "registered address "and" industrial and commercial business license "is the same;

(3) "product name", "specifications" and the submitted product standards, test reports and other application materials used in the name, specifications consistent.

2, medical device manufacturer qualifications

(1) qualifications include "medical device manufacturer license" copy and "business license" copy. (2) Application for registration of the product should be in the "Medical Device Manufacturer License" approved within the scope of production;

(3) "Medical Device Manufacturer License" and "Business License" within the validity period.

3, product technical report product technical report should include at least the following:

(1) product characteristics, working principle, structural composition, intended use;

(2) product specifications or the main performance requirements determined on the basis of;

(3) product design and control, development, research and development process;

(4) the product's main process and description;

(5) product testing and clinical trials. ) Product testing and clinical trials;

(6) Comparative analysis with similar products at home and abroad.