Medical Device Production Supervision and Administration Measures (State Market Supervision and Administration Decree No. 53) (hereinafter referred to as the "Production Measures") has been issued, since May 1, 2022 shall come into force. In order to do a good job of the city's medical device production licensing and filing related work, according to the "State Drug Administration on the implementation of the" supervision and management of medical equipment production approach "supervision and management of medical equipment business approach" notice of the relevant matters "(2022 No. 18) requirements, combined with the city's actuality, is now the relevant matters are notified as follows:
One, and effectively strengthen publicity and training for the implementation of the work
The city's drug supervision and management departments at all levels to strengthen the "production methods" of learning and training, a deep understanding, accurate mastery, combined with local practice, and conscientiously carry out the implementation of the actual implementation of the implementation of the responsibility to effectively implement the quality and safety of medical devices supervision and management.
Enterprises engaged in the production of medical devices, to strengthen the medical device regulations and rules to learn and train, and seriously implement the requirements of the rules and regulations, and effectively fulfill the responsibility of medical device product quality and safety management.
Two, on the medical device production license matters for
(a) Since May 1, 2022, the application for the city's second and third class medical device production license matters should be implemented in the following procedures developed by the Bureau:
1. "Medical Device Manufacturing License" issuance;
2. "Medical Device Manufacturing License" licensing matters change
3. "Medical Device Manufacturing License" registration changes;
4. "Medical Device Manufacturing License" continuation;
5. "Medical Device Manufacturing License" reissuance;
6. "Medical Device Manufacturing License" cancellation;
7. Medical device products export sales certificate.
(ii) in May 1, 2022 I have accepted but not yet approved the production of medical devices licensing matters, in the "production approach" after the implementation of the "production approach" on the conditions of the Funtai, in accordance with the "production approach" the time limit for processing and issuance of "medical device production license. The new production license number format for the "Beijing drug supervision and mechanical production Xu XXXXXXX No.", of which the first to four X on behalf of the 4-digit license year, the fifth to eight X on behalf of the 4-digit license number.
(C) the existing validity of the "medical device production license" continues to be valid. After the implementation of the "production methods", "medical device production license" need to change, continuation, reissue, cancellation, I will be in accordance with the "production methods" of the relevant provisions. Change, reissue of the license, the validity period remains unchanged; change, continuation, reissue of the license, the license number is arranged by the "Beijing Food and Drug Administration Mechatronics Production Xu XXXXXXXXXX No." change to "Beijing Drug Administration Mechatronics Production Xu XXXXXXXXXX No.
(d) has obtained a "medical device production license" of the manufacturer, "production methods" after the implementation of the enterprise's workshop or production line for renovation, resulting in changes in production conditions, which may affect the safety of medical devices, effective, should be reported to the enterprise's location of the municipal Food and Drug Administration branches. Belong to the licensing matters change, should be in accordance with the "production methods" for the relevant license change procedures.
Three, on the medical device production matters for the record
(a) Since May 1, 2022, the application for the city's first class of medical devices production matters for the record should be implemented in the following procedures developed by the Bureau:
1. first class of medical devices production for the record;
2. "First class of medical devices for the record vouchers" change;
3. p>3. "Class I medical device production record voucher" reissued.
(ii) the city to engage in the production of Class I medical devices should be carried out before the production of the residence of the district market supervision and management department for the record; the filing of their own production, you can apply for product filing for the record of production. Production enterprises are responsible for the authenticity, completeness and compliance of the filing information. The new record of the record number format for "Beijing X drug supervision and equipment production preparation XXXXXXXX No.", where the first X on behalf of the abbreviation of the region where the enterprise is domiciled, the second to five X on behalf of the 4-digit filing year, the sixth to the ninth X on behalf of the 4-digit filing water number.
(C) the existing has been made for the record, "the first class of medical devices production record certificate" continues to be valid. After the implementation of the "production methods", "the production of Class I medical devices for the record voucher" need to change or reissue, I will be in accordance with the "production methods" of the relevant provisions. Changes, reissued for the record certificate, the record number of the arrangement by "Beijing X food and drug supervision and mechanical production of XXXXXXXXXX No." change to "Beijing X drug supervision and mechanical production prepared
xXXXXXXXXX No.", the number of numbers remain unchanged.
Four, has been entrusted with the production of the record of enterprises
The city has been for the "medical device commissioned the production of the production of the record voucher" of the production company, the existing commission within the period of the record voucher continues to be valid; commissioned to continue to produce the expiration of the production, in accordance with the "production methods" on the production of licenses and production of record-keeping matters related to the relevant provisions of the process.
Fifth, other matters for
(a) Since May 1, 2022, the city enterprises to accept other provinces, autonomous regions, municipalities directly under the Central Government of the medical device registrant commissioned the production of Class II, Class III medical devices, should be submitted to the Bureau of Medical Devices Supervision and Administration of the Medical Devices Production Management Office of a written description of the material, I will consult the registrant of the location of the provinces, autonomous regions, municipalities directly under the Central Government of the Drug Administration, and the production of medical devices. In accordance with the provisions of the "production methods" for the production license issued or changed.
(B) the city's medical devices commissioned by the production of enterprises to terminate the commissioned production, should be in accordance with the "production methods" to the original production license or production record department to report or for change.
(3) Since May 1, 2022, medical device manufacturers to produce product varieties change, the relevant enterprises should log in the Bureau's enterprise service platform of the "medical device production information reporting" system, the relevant product information will be filled into the system "significant matters" module. Collection" module.
Sixth, the implementation of the requirements
This circular was issued and implemented, "Beijing Municipal Drug Administration on medical device production licensing and filing of matters related to the work of the circular" (Circular [2020] No. 8) document is repealed at the same time. The State Drug Administration has other documents, in accordance with its provisions.