How to apply for a production license
1, application
(1) enterprises for the production license must fill out a unified format of the "Production License Application Form" four copies, reported to the Quality and Technical Supervision Bureau of the Business Section.
(2) enterprises should also provide the following information: business license of the enterprise legal person; routine (type) test reports; environmental protection, health certificates.
(3) Business Section will be all the information after passing the preliminary examination, the application information will be reported to the Quality and Technical Supervision Bureau of Quality, by the Municipal Bureau of unified arrangements for the preliminary examination and inspection.
(4) Municipal Bureau of the preliminary examination of the application materials reported to the Provincial Bureau of Quality and Technical Supervision.
2, acceptance
Provincial Bureau of Quality and Technical Supervision acceptance of the application materials, should be within seven working days to meet the reporting conditions of the enterprise issued a "production license acceptance notice.
3, on-site review
(1) production license implementation rules by the provincial Bureau of Quality and Technical Supervision is responsible for organizing the enterprise production conditions and sealing of samples, the provincial Bureau of Quality and Technical Supervision shall accept the application within 2 months after the organization of the production conditions for the review and on-site sampling of sealed samples. Provincial licensing office from the date of acceptance of the application within 3 months from the date of completion of the material summary, and the list of qualified enterprises and related materials reported to the Department of review. Review of the Department of Quality and Technical Supervision from the receipt of the provincial quality and Technical Supervision submitted materials from the date of 45 days to complete the enterprise production conditions and material summary, and will be qualified enterprises and related materials reported to the National Licensing Office;
(2) production license implementation rules for the review of the Department of the organization of the production conditions of the enterprise production and sealing of samples, the provincial Quality and Technical Supervision should be admitted to the application of the enterprise within 15 days after the relevant materials forwarded to the Department. Relevant materials forwarded to the Department of review. Review Department from the date of receipt of the materials submitted by the provincial licensing office within two months from the date of the organization of the production conditions of enterprises applying for licensing review, and on-site sampling and sealing of samples. Review Department from the date of receipt of the provincial licensing office submitted materials within 3 months from the date of the list of qualified enterprises and related materials reported to the National Production Licensing Office;
(3) apply for licensing of enterprises to review the production conditions by the review team, the review team to implement the system of responsibility of the team leader, the review team is responsible for the review report.
4, sample test
Application for certification should be sealed within 15 days of the sample will be sent to the designated inspection agency. Inspection agency to be samples, should be in accordance with the implementing regulations of the standards and requirements for testing, and should be completed within the specified period of time for testing. Standards for product testing have special requirements, according to the standard provisions. Product testing cycle more than Article XIV time limit for the submission of materials, materials submission time to test the completion of time shall prevail.
5, summary, validation, licensing
National Licensing Office since the receipt of the provincial Quality and Technical Supervision, review of the Department of the summary of the licensing conditions in line with the list of enterprises and the relevant materials within 1 month from the date of completion of the validation. After validation, meet the licensing conditions, issued by the State Administration of Quality Supervision production license, does not meet the licensing conditions, the reported materials will be returned to the relevant provincial quality and Technical Supervision Bureau or review the Department and inform the enterprise.
6, post-processing
Provincial Quality and Technical Supervision shall not meet the licensing conditions of the enterprise issued a "production license review failed notice", while withdrawing the "production license acceptance notice.
Enterprises since the receipt of the "production license review failed notice" date, should be seriously rectified, two months before applying for a license again.
1, "State Food and Drug Administration" on behalf of the product within the third class of medical devices issued by the State Food and Drug Administration. Note: The same applies to imported Class II and Class III medical device products.
2. "(Quasi)" represents the domestic medical devices; "2014" is the year of the first registration of the product.
3, "No. 3541699" in the "3" means: the device is a Class III medical device; "No. 3541699" in the "1699". Operating room, emergency room, diagnostic and treatment room equipment and apparatus; (see "State Food and Drug Administration Medical Device Classification Catalog").
Safety production license is valid for 3 years, in the validity of the annual inspection. According to "safety production license regulations" Article IX safety production license is valid for three years. The validity of the safety production license needs to be extended, the enterprise should be expired three months before the original safety production license issued to the management body for the extension procedures. Enterprises in the validity of the production safety license, strict compliance with laws and regulations relating to production safety, the end of fatal accidents, the validity of the production safety license expires, the original production safety license issued by the management body agrees, no longer review, the validity of the production safety license is extended for three years.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices," Article V. The development of medical devices should follow the principle of safety, effectiveness and economy. The state encourages the research and innovation of medical devices, plays the role of market mechanism, promotes the popularization and application of new technology of medical devices, and promotes the development of medical device industry.