The Application Form for Medical Device Registration is one of the important materials to apply for registration, and all the contents in the form should meet the requirements of filling in the instructions.
Two, medical device manufacturing enterprise qualification certificate
(a) a copy of the license and business license of the production enterprise, and affix the official seal of the enterprise to which the certificate belongs;
(2) The products applied for shall be within the production scope approved by the production enterprise license;
(3) Within the validity period.
Three, the product technical report should be stamped with the official seal of the production enterprise.
Four. Safety risk analysis report
The official seal of the production enterprise shall be affixed.
Verb (abbreviation of verb) product standard
(a) the standard text, should be stamped with the official seal of the production enterprise;
(2) preparation instructions (applicable to registered product standards);
(3) The declared products should be included in the product standards;
(four) the use of national standards and industry standards as the applicable standards for products:
1. The production enterprise shall provide a statement that the products applied for meet the national standards and industry standards, and affix the official seal of the production enterprise;
2. A statement that the production enterprise bears the quality responsibility after the product is listed, and affix the official seal of the production enterprise;
3 description of the product model and specification of the production enterprise, and affix the official seal of the production enterprise.
Six, product performance self-inspection report
(a) signed by the chief inspector or the chief inspector and the auditor, and stamped with the official seal of the production enterprise; (two) the implementation of national standards and industry standards, the production enterprise shall supplement the custom factory inspection items, and affix the official seal of the production enterprise.
Seven, test report
(1) The specifications and models of the products under inspection are within the scope of this registration application;
(two) the type of testing should be registered testing or full-performance national supervision and spot check testing;
(3) the original;
(4) Within the validity period (according to Article 7 of Annex 3 of the Measures).
Note: If the provisions of Articles 11, 12 and 13 of the Measures are implemented, the production enterprise shall provide corresponding explanatory documents and affix the official seal of the production enterprise.
Eight, medical device registration consulting clinical trial data
(a) the production enterprise shall conduct clinical trials in two or more (including two) "national drug clinical research bases";
(2) Clinical trial data shall include clinical trial contract, clinical trial plan and clinical trial report:
1. The clinical trial contract shall be signed and sealed by the medical institution undertaking the clinical trial and the implementer;
2. The clinical trial plan shall be sealed by the ethics committee, the medical institution undertaking the clinical trial and the implementer;
3. The clinical trial report shall be signed by the clinical trial leader and clinical trial personnel, and confirmed by the test department.
Nine, medical device registration consultation manual
Instructions shall be provided and stamped with the official seal of the production enterprise; If the explanation is omitted, the production enterprise shall issue an explanation document and affix the official seal of the production enterprise.
X. Effective certification documents for product quality system review (certification)
XI。 Self-assurance statement on the authenticity of the submitted materials
(1) List of materials submitted;
(two) the commitment of the production enterprise to bear legal responsibility;
(three) stamped with the official seal of the production enterprise.