1. NMPA has revised the list of medical devices prohibited from contract manufacturing, which is promulgated and will take effect from May 1,2022. The previous CFDA announcement on issuing of the list of medical devices prohibited from contract manufacturing (no. 18 of 2014) shall be repealed at the same time.

2. In order to strengthen supervision over the production of medical devices, to ensure the safety and effectiveness of medical devices, and to guide medical device registrants and contract manufacturers to produce medical devices under good quality management. The guideline for the Quality Agreements of Contract Manufacturing Medical Devices is therefore laid down and promulgated by NMPA.

3.1 From May 1, 2022, <Measures for the Supervision and Administration of the Operation of Medical Devices> and <Measures for the Supervision and Administration of the Production of Medical Devices> have come into force. After the implementation of the <Measures for Production> and the <Measures for Operation>, applications of licenses for the production and operation of medical devices, which have been submitted before the implementation date (May 1, 2022), but have not yet received approval, shall nonetheless be processed, and subsequently issued in accordance with the new <Measures for Production> and the new <Measures for Operation>.

3.2 From May 1, 2022, the previous CFDA announcement on matters concerning the implementation of the <Measures for the Supervision and Administration of the Medical Devices Production> and <Measures for the Supervision and Administration of the Medical Devices Operation> (No. 143[2014] of CFDA) shall be repealed.

 

 

Reference:
Announcement of NMPA on Issuing the List of Medical Devices Prohibited from Contract Manufactuing (No. 17 of 2022)
Announcement of NMPA on Issuing the Guideline for the Quality Agreements of Contract Manufacturing Medical Devices (No. 20, 2022)
Announcement of NMPA on Matters Concerning the Implementation of the <Measures for the Supervision and Administration of the Production of Medical Devices> and the <Measures for the Supervision and Administration of the Operation of Medical Devices> (No. 18, 2022)

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