I'm a medical device registrar, for a BS like you who only takes materials but doesn't supply them.
Documents and materials required for registration of dentures
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Release date: May 24, 2005 popularity: 62060
Keywords: registered medical devices
Documents required for domestic registration of Class II and Class III medical devices
(1) Application form for registration of domestic medical devices;
(2) Qualification certificate of medical device manufacturing enterprise:
Including a copy of the production enterprise license and business license, and the products applied for shall be within the production scope approved by the production enterprise license;
(3) Product technical report:
At least the technical indicators or the basis for determining the main performance requirements shall be included;
(4) Safety risk analysis report:
According to the requirements of YY03 16 Risk Analysis of Medical Devices. There should be an analysis of energy hazards, biological hazards, environmental hazards, related use hazards and hazards caused by functional failure, poor maintenance and aging, as well as corresponding preventive measures;
(5) Applicable product standards and descriptions:
Where national standards and industry standards are adopted as applicable standards for products, the texts of the adopted national standards and industry standards shall be submitted; The registered product standard shall be signed and sealed by the production enterprise.
The production enterprise shall provide a statement that the product applied for conforms to the national standards and industry standards, a statement that the production enterprise bears the quality responsibility after the product goes on the market, and a description of the division of product models and specifications;
(six) product performance self-inspection report:
The product performance self-inspection item is the ex-factory inspection item specified in the registered product standard, which is signed by the chief inspector or the chief inspector and the auditor. Where national standards and industry standards are implemented, the production enterprise shall supplement the customized ex-factory inspection items;
(seven) the product registration test report issued by the medical device testing institution:
Medical devices that need clinical trials shall submit the test report issued by the medical device testing institution within six months before the start of clinical trials. For medical devices that do not need clinical trials, the test report issued by the medical device testing institution within 1 year before registration acceptance shall be submitted.
Where the provisions of Articles 11, 12, 13 and 14 of these Measures are implemented, the corresponding explanatory documents shall be provided;
(eight) clinical trial data of medical devices;
(9) Instructions for medical devices;
(10) Effective certification documents for product quality system review (certification)-Provide corresponding quality system review reports according to the requirements of different products:
1, the system review report signed by the (food) drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government within the validity period;
2, medical device production quality management standard inspection report or medical device quality system certification;
3, the state has implemented the detailed rules for the implementation of production, submit the inspection and acceptance report of the detailed rules for the implementation;
(eleven) the self-assurance statement of the authenticity of the submitted materials:
It should include the list of materials submitted and the commitment of the production enterprise to bear legal responsibility.
Documents required for replacing domestic second-class and third-class products
When re-registering the domestic production of Class II and Class III medical devices, the following materials shall be submitted:
1. Qualification certificate of medical device manufacturer.
2. A copy of the original registration certificate.
3. The product quasi-production registration type test report issued by the medical device quality testing institution recognized by the State Administration of Pharmaceutical Products in the last year.
4. Effective certification documents for enterprise quality system review (certification).
5. Registered product standards and preparation instructions.
6. Product quality tracking report.
7. Self-assurance statement on the authenticity of the submitted materials.
Category II and Category III overseas medical devices that have not obtained the listing permit for overseas medical devices.
Requirements of application materials for the first registration of medical devices
(1) An application form for registration of overseas medical devices;
(2) Qualification certificate of medical device manufacturing enterprise;
(3) Product technical report:
At least the technical indicators or the basis for determining the main performance requirements shall be included;
(4) Safety risk analysis report:
According to the requirements of YY03 16 Risk Analysis of Medical Devices. The hazards caused by energy hazards, biological hazards, environmental hazards, related use hazards and functional failure, poor maintenance and aging, and corresponding preventive measures should be analyzed.
(5) Applicable product standards and descriptions:
Where Chinese national standards and industry standards are adopted as applicable product standards, the texts of the adopted Chinese national standards and industry standards shall be submitted; The registered product standard shall be signed by the manufacturer or its representative office in China or the drafting unit entrusted by the manufacturer. The power of attorney entrusted by the production enterprise to draft the standard shall indicate that "the product quality is the responsibility of the production enterprise".
The production enterprise shall provide a statement that the product applied for conforms to China's national standards and industry standards, a statement that the production enterprise assumes quality responsibility after the product is listed, and a description of the product model and specification division;
(six) product performance self-inspection report:
The product performance self-inspection item is the ex-factory inspection item specified in the registered product standard, which is signed by the chief inspector or the chief inspector and the auditor. Where national standards and industry standards are implemented, the production enterprise shall supplement the customized ex-factory inspection items.
(seven) the product registration test report issued by the medical device testing institution:
Medical devices that need clinical trials shall submit the test report issued by the medical device testing institution within six months before the start of clinical trials. For medical devices that do not need clinical trials, the test report issued by the medical device testing institution within 1 year before registration acceptance shall be submitted.
Where the provisions of Articles 11, 12, 13 and 14 of these Measures are implemented, corresponding explanatory documents shall be provided.
(eight) clinical trial data of medical devices (see Annex12 of these Measures for specific submission methods);
(9) Instructions for medical devices (signed and sealed by the manufacturer or its representative office in China);
(10) Effective certification documents for product quality system review (certification):
The application for registration shall be submitted to the State Food and Drug Administration's evaluation report on the production quality system of medical devices.
(eleven) the power of attorney, agent commitment letter, business license or agency registration certificate of the designated agent of the production enterprise in China:
The contents of the agency undertaking shall be consistent with the matters entrusted in the power of attorney of the production enterprise. The agent shall also promise to report the adverse events of medical devices in the letter of commitment and contact the (food) drug supervision and administration department;
(12) power of attorney, letter of commitment and qualification documents of the entrusted institution of the designated after-sales service institution in China;
The power of attorney for after-sales service shall be issued by the production enterprise, and the power of attorney shall specify the product name. In the case of multi-level entrustment, the entrusting agency at each level shall provide the approval documents of the production enterprise.
The contents of the commitment letter of the after-sales service institution shall be consistent with the matters entrusted by the power of attorney.
The qualification certificate of the after-sales service organization is the business license (its business scope should have corresponding technical service items) or the registration certificate of the organization of the production enterprise in China;
(13) self-assurance statement on the authenticity of the submitted materials:
It shall be issued by the production enterprise or its representative office in China, and the statement shall list the submitted materials and include the commitment to bear legal responsibilities.
All the above documents shall be in Chinese. The supporting documents in Item (2) of this annex may be photocopies, but they must be signed by the original issuing authority or notarized by the local notary office; Unless otherwise stipulated in these Measures, other documents in this annex shall be submitted to the original signed by the production enterprise or its office or representative office in China.