US Food and Drug Administration [20 14]No. 143
All provinces, autonomous regions and municipalities directly under the Central Government of the US Food and Drug Administration:
The Measures for the Supervision and Administration of Medical Device Production (Order No.7 of China Food and Drug Administration) (hereinafter referred to as the Measures for Production) and the Measures for the Supervision and Administration of Medical Device Operation (Order No.8 of China Food and Drug Administration) (hereinafter referred to as the Measures for Operation) have been issued and will be implemented from 20 14 to 10. The relevant matters are hereby notified as follows:
First, food and drug supervision and management departments at all levels should strengthen the publicity and training of the "Production Measures" and "Management Measures", deeply understand and master them, and conscientiously implement them in light of the actual work in their respective administrative regions.
Two, since 20 14, 10, 1, the production license and filing of newly established medical device manufacturing enterprises shall be handled in accordance with the relevant provisions of the Production Measures.
20 14+00+ 1 The application for the license of the newly established medical device manufacturing enterprise that has been accepted but not approved before shall be handled in accordance with the relevant provisions of the production measures after the implementation of the production measures.
Three, the existing "medical device manufacturing enterprise license" will continue to be valid within the validity period. After the implementation of the "Production Measures", if a medical device manufacturing enterprise applies for change, extension or replacement, it shall conduct an audit in accordance with the relevant requirements of the "Production Measures", conduct on-site verification when necessary, and issue a new "Medical Device Production License" if it meets the prescribed conditions. The validity period is calculated from the date of issuance.
If a class I medical device manufacturing enterprise has been registered, the manufacturing enterprise shall, before March 36, 2065 +0, handle a class I medical device production record with the local municipal food and drug supervision and administration department.
Four, the original has been registered for the second and third categories of medical devices commissioned production, after the implementation of the "Production Measures", when the license of the medical device manufacturing enterprise entrusted by any party expires or changes, continues or is renewed, the original commissioned production registration shall be terminated. If it is necessary to continue to entrust production, the entrusted production procedures shall be handled in accordance with the relevant provisions of the "Production Measures".
For those who have been registered to entrust the production of Class I medical devices, the registration of entrusted production will end on March 3, 20051. If it is necessary to continue to entrust production, the relevant procedures for entrusted production shall be handled in accordance with the relevant provisions of the Production Measures.
Five, medical device manufacturing enterprises "medical device manufacturing enterprise license" involves the establishment of production sites across provinces, can be produced until the validity of the "medical device manufacturing enterprise license". Where a production site established across provinces needs to continue production, it shall separately apply to the local provincial food and drug supervision and administration department for a production license in accordance with the relevant provisions of the Production Measures.
The "Registration Form of Medical Device Manufacturers of Class I" involves the establishment of production sites across cities divided into districts, which can be produced until March 3, 2065438. If the production sites set up in trans-regional cities need to continue production, they shall, in accordance with the relevant provisions of the production methods, handle the production record of Class I medical devices with the municipal food and drug supervision and administration department with districts.
Six, the export of medical devices manufacturing enterprises should export products related information to the local municipal food and drug supervision and management departments for the record. Relevant information includes export products, production enterprises, export enterprises, countries (regions) sold to, and whether overseas enterprises have commissioned production.
Seven, since 20 14, 10, 1, the new medical device business license and filing shall be handled in accordance with the relevant provisions of the administrative measures.
20 14+00+ 1 The application for the license of the newly established medical device business enterprise that has been accepted but not approved before shall be handled in accordance with the relevant provisions of the Business Measures after the implementation of the Business Measures.
Eight, the existing medical device business enterprise "medical device business enterprise license" will continue to be valid within the validity period. After the implementation of the Administrative Measures, if a medical device business enterprise applies for change, renewal or replacement, involving the operation of Class III medical devices, it shall conduct an audit in accordance with the relevant requirements of the Administrative Measures, conduct on-site verification when necessary, and issue a new Medical Device Business License if it meets the prescribed conditions, and the validity period shall be calculated from the date of issuance; Involving the operation of Class II medical devices, it shall be filed in accordance with the relevant requirements of the Operation Measures.
Nine, the "production measures", "management measures" and related forms involved in this notice are attached.
Ten, since the implementation of the "production measures" and "management measures", where inconsistent with the requirements of this notice, according to the requirements of this notice, the work should be timely feedback to the General Administration.
Attachment: 1 Medical device production license (sample) and certification specification
2 medical device production license application form (sample form)
3 medical device production license change application form (sample form)
4 medical device production license extension application form (sample form)
5. Application form for replacement of medical device production license (sample form)
6 medical device production license cancellation application form (sample form)
7. Record Form for Production of Class I Medical Devices (Sample Form)
8. Filing vouchers for the production of Class I medical devices (sample form)
9. Change Table of Production Records of Class I Medical Devices (Sample Table)
10. Supplementary publication of the production record voucher of Class I medical devices (sample table)
1 1. Record Form for Entrusted Production of Medical Devices (Sample Form)
12. Record Voucher for Entrusted Production of Medical Devices (Sample Table)
13. medical device export record form (sample form)
14. Medical device business license (sample) and certification specification
15. application form for medical device business license (sample form)
16. application form for change of medical device business license (sample form)
17. application form for extension of medical device business license (sample form)
18. application form for renewal of medical device business license (sample form)
19. application form for cancellation of medical device business license (sample)
20. Operation Record Form of Class II Medical Devices (Sample Form)
2 1. Record Voucher for Operation of Class II Medical Devices (Sample Table)
22. Change Form for Business Filing of Class II Medical Devices (Sample Form)
23. Supplementary publication of second-class medical device business record vouchers (sample form)
China US Food and Drug Administration (CFDA)
2065438+August 04 1