I am a medical device registration commissioner, for your kind of BS only pick not for supply
Documents and materials required for registration of denture
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Published: 2005-5-24 11:12:00 Popularity: 62060
Keywords: registration of medical devices
Domestic registration of Class II, Class III medical devices required documents
(a) the territory of the application form for registration of medical devices;
(b) medical device manufacturer qualification certificates:
including the manufacturer's license, a copy of the business license, and the products applied for should be in the production of the manufacturer's license within the approved production range;
(C) product technical reports:
Should include at least the technical indicators or the main performance requirements of the determination of the basis of content;
(D) safety risk analysis report:
In accordance with the requirements of YY0316 "Medical Device Risk Analysis" standard preparation. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and hazards caused by functional failure, poor maintenance and aging and other five aspects of the analysis and the corresponding precautionary measures;
(E) the applicable product standards and descriptions:
Adopted by the national standards, industry standards as the applicable standards of the product should be submitted to the national standards, industry standards adopted by the text; the registered product standards should be by YY0316 "medical device risk analysis" standard requirements. The text; registered product standards should be signed by the manufacturer.
Producers should provide the application for products in line with national standards, industry standards, the statement that the manufacturer assumes responsibility for the quality of the products listed on the statement as well as the relevant product models, specifications and division of the description;
(F) self-test report of product performance:
Product performance of self-test items for the registration of the product standards for the factory inspection program, there should be a principal inspector Or the person in charge of the main inspection, the auditor's signature. The implementation of national standards, industry standards, manufacturers should supplement the self-defined factory test items;
(VII) medical device testing organizations issued by the product registration test report:
Medical devices need to carry out clinical trials should be submitted to clinical trials within six months before the start of the test report issued by the medical device testing organizations. Do not need to conduct clinical trials of medical devices, should be submitted to the registration acceptance within one year before the test report issued by the medical device testing organizations.
Implementation of the provisions of Article 11, Article 12, Article 13, Article 14 of these measures, should provide the corresponding description of the document;
(h) medical device clinical trial information;
(ix) medical device instruction manual;
(j) product production quality system assessment (certification) of the validity of the supporting documents --According to the requirements of different products, provide the appropriate quality system assessment report:
1, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department signed, within the validity period of the system assessment report;
2, medical device production quality management standard inspection report or medical device Quality system certification;
3, the state has implemented the implementation of production rules, the implementation of rules submitted to the inspection and acceptance of the report;
(k) the authenticity of the materials submitted to the self-assurance statement:
Should include a list of the materials submitted to the production of the enterprise to assume legal responsibility for the commitment.
Documents required for domestic renewal of Class II and Class III products
Domestic production of Class II and Class III medical devices re-registration, the following materials should be submitted:
1. Certificate of qualification of medical device manufacturers.
2. A copy of the original registration certificate of permitted production.
3. State Drug Administration recognized medical device quality testing organizations within the last year issued by the product type test report for registration.
4. Enterprise quality system assessment (certification) of effective documents.
5. Registered product standards and compilation instructions.
6. Product quality tracking report.
7. The authenticity of the materials submitted to the self-assurance statement.
Not obtaining overseas medical device marketing authorization for Class II, Class III overseas
Medical devices for the first time the registration application requirements
(a) overseas medical device registration application form;
(b) medical device manufacturer qualification certificates;
(c) the product technical report:
Should include at least the technical indicators or the main performance requirements to determine the basis, etc. Or the main performance requirements of the determination of the basis of content;
(D) safety risk analysis report:
In accordance with the requirements of YY0316 "Medical Device Risk Analysis" standard compilation. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and by the failure of function, poor maintenance and aging caused by the hazards of five aspects of the analysis and the corresponding when the preventive measures.
(E) applicable product standards and instructions:
Adoption of Chinese national standards, industry standards as applicable product standards, should be submitted to the adopted Chinese national standards, industry standards of the text; registered product standards should be signed by the producer or its representative office in China or the producer commissioned to draft standards for the unit signed. Producers entrusted to draft standards should be noted in the commission "product quality by the producer is responsible for".
Producers should provide the application for products in line with Chinese national standards, industry standards, the statement that the manufacturer assumes responsibility for the quality of the product on the market, as well as the product model, specifications and division of the description;
(F) product performance self-test report:
Product performance self-test project for the registration of product standards for the factory inspection program, should be Have the main inspector or the person in charge of the main inspection, the auditor's signature. Implementation of national standards and industry standards, manufacturers should supplement the self-defined factory test items.
(VII) medical device testing organizations issued by the product registration test report:
The need for clinical trials of medical devices, should be submitted to the start of clinical trials within six months before the start of the test report issued by the medical device testing organizations. Do not need to conduct clinical trials of medical devices, should be submitted to the registration acceptance within one year before the test report issued by the medical device testing organizations.
The implementation of the provisions of Article 11, Article 12, Article 13, Article 14 of these measures, should provide the appropriate documents.
(viii) medical device clinical trial information (see Annex 12 for specific submission);
(ix) medical device specification (should be signed by the manufacturer or its representative office in China);
(j) the product quality system assessment (certification) of valid documents:
Submitted to the State Food and Drug Administration on the Application for registration of medical devices production quality system assessment report.
(k) the manufacturer in China to designate the agent's power of attorney, the agent's statement of commitment and business license or institutional registration certificate:
The agent's statement of commitment should be the same as the manufacturer's power of attorney entrusted to the matter. The agent shall also undertake in the letter of commitment to be responsible for the reporting of adverse events of medical devices, and is responsible for contacting the (food) drug supervision and management department;
(xii) the power of attorney to designate the after-sales service organization in China, the entrusted organization's letter of commitment and qualification documents:
After-sales service entrustment shall be issued by the manufacturer, the entrustment letter shall set out the name of the product, and the multi-tier entrustment When the multi-level commissioning, each level of commissioning organization must provide the manufacturer's recognition of the document.
After-sales service organization's commitment to the content of the commitment should be consistent with the entrusted matters entrusted in the power of attorney.
The qualification documents of the after-sales service organization are business license (its business scope should have the corresponding technical service items) or the registration certificate of the manufacturer's organization in China;
(xiii) Self-guarantee statement of the authenticity of the submitted materials:
The statement should be issued by the manufacturer or its representative office in China, and the statement should set out a list of the submitted materials and include a commitment to bear the legal responsibility. include a commitment to assume legal responsibility.
All of the above documents should be available in Chinese. This Annex (b) supporting documents can be copies, but must be signed by the original issuing authority or notarized by the local notary public; in addition to the other provisions of this approach, the other documents in this Annex should be submitted by the manufacturer or its office or representative office in China to sign the original.