IVDs

On October 29, 2021, the NMPA published the In Vitro Diagnostic Reagents Classification Rules for the first time as an individual document.

NMPA published a revised the clinical trial exemption list for medical devices and IVD reagents which became effective on October 1, 2021.

The NMPA announced the plan for the implementation of UDI for the remaining class III products which do not yet require UDI.

The new medical device (Order 47) and the new IVD (Order 48) regulations will be effective from October 1, 2021 onwards.

The CMDE published several interesting case studies to address some of the detailed requirements for IVD and SiMD registration in China

NMPA published a regulatory draft to require all class III medical devices and IVDs manufactured after March 1, 2022 to have UDI.

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.

On January 19, the NMPA announced the new clinical trial exemption list for medical devices and in-vitro diagnostics reagents.

A total number of 10579 applications and 9849 approvals for medical device registrations in China were reported in 2020 along with a detailed breakdown.

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.