Medical Devices
On January 19, the NMPA announced the new clinical trial exemption list for medical devices and in-vitro diagnostics reagents.
NMPA’s recent release of the updated product information of 29 IVD reagents, primarily to down-classify from class III to class II, was long overdue.
On July 29, 2020 the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) released a draft of the proposed amendment to the list of medical devices and IVDs to be exempted from clinical trials:
The draft proposes to add 53 medical devices (Class II: 34; Class III: 19) and 15 IVDs (Class II: 13; Class III: 2) to the clinical trial exemption list. Also, the names and descriptions of 11 medical devices (Class II: 9; Class III: 2) are proposed for revision, while there are 2 medical devices being combined with other products.
Here are the links to:
Proposed amendment for the list of medical devices to be exempted from clinical trials
Proposed amendment for the list of IVDs to be exempted from clinical trials
The CMDE is currently soliciting for public comments, and the public consultation ends on August 31, 2020.
By Jacky Li. Contact Cisema if you would like to learn more.
On June 9, the CMDE (Center of Medical Device Evaluation) of NMPA (National Medical Products Administration) announced the initiative to draft the technical review guidelines for the registration of:
- Reagents for rotavirus antigen tests
- Real-time qPCR instruments
- Reagents for testing IgM and IgG antibodies against HPV B19
- Reagents for GBS nucleic acid tests
Manufacturers of the above products were invited to sign up and cooperate with the CMDE to provide any needed assistance.
On July 1, the CMDE released the technical review guidelines (2nd draft) for the change of licensing items for IVD Reagents. The CMDE is currently soliciting public comments until July 25, 2020.
On July 3, the CMDE of NMPA announced the initiative to draft the technical review guidelines for the registration of IVD reagents utilizing overseas clinical data.
By Jacky Li. Contact Cisema if you would like to learn more about the above news.
NMPA published a regulatory draft to require all class III medical devices and IVDs manufactured after March 1, 2022 to have UDI.
The CMDE published several interesting case studies to address some of the detailed requirements for IVD and SiMD registration in China
New revised law on the Supervision and Administration of Medical Devices (Order 739) issued by the State Council came into force in June 2021
The NMPA is currently soliciting public comments on the draft documents. The public consultation period is open until May 30, 2021.
6 technical guidelines & 4 GB / YY draft standards were announced; 2 products registered & 7 applications accepted by the fast-track approval pathway.
NMPA published a revised the clinical trial exemption list for medical devices and IVD reagents which became effective on October 1, 2021.
The new medical device (Order 47) and the new IVD (Order 48) regulations will be effective from October 1, 2021 onwards.
The NMPA announced the plan for the implementation of UDI for the remaining class III products which do not yet require UDI.
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