(a) "Application Form for Inspection of Quality Management Standard for the Production of Medical Devices" (Schedule 1), accompanied by an electronic copy of the application form;
(b) copy of the "Medical Device Manufacturer's License" and a copy of the business license;
(c) the production enterprise Organization chart;
(iv) resume of the person in charge of the production enterprise, production, technology and quality management department, a copy of the certificate of education and title;
(v) a copy of the certificate of registration of the medical device of the product for which the inspection is applied for (if any), and the standard of the product to be registered;
(vi) the general layout plan of the production enterprise, the process flow diagram, and the map of the distribution of the production area;
(vii) a copy of the license of medical device production enterprise and a copy of the business license;< /p>
(vii) the main production equipment and inspection equipment catalog;
(viii) the production of sterile medical devices, should provide a qualified testing organization issued within one year of the production environment test report.
National Bureau of Certification Management Center from the date of receipt of the application information within 10 working days of the application data for information review, and fill out the "Medical Device Production Quality Management Standard Inspection Information Review Form". For the application information does not meet the requirements, should be a one-time requirement for the production enterprise to supplement. Production companies did not submit within 2 months to supplement the material and no valid reason, terminate the review.
The conclusion of the inspection of the quality management standard for the production of medical devices is divided into "through the inspection", "rectification and review", "did not pass the inspection" in three cases.
The need for rectification review, the manufacturer should be submitted within six months to review the application and rectification report. Rectification review by the original inspection department. Review should be completed within 30 working days after receiving the application for review, rectification review still does not meet the "through the inspection" standard, the inspection concluded that "did not pass the inspection". Failure to submit the application for review and rectification report within the prescribed time limit is deemed to have "failed the inspection".
Failure to pass the inspection of the manufacturer can be six months after the re-application in accordance with this method of medical device production quality management standard inspection.