Medical Devices

The CNAS issued the CNAS-EL-21: 2022 to provide guidance for applying for the accreditation for group enterprise internal laboratories.

The NMPA issued the technical review guideline for medical device-based combination products, and on drug release studies required...

The NMPA published the 14th Five-Year Plan for National Drug Safety and Promotion of High Quality Development setting goals to (i) achieve...

Cisema webinar on drug registration pathways will provide an overview of the regulatory environment for medicines in China.

Overseas clinical trial data for IVD registration in China now adopts the new technical guidelines issued on December 1, 2021, by the NMPA.

8 GB standards and 19 YY/T standards have been approved whilst NMPA issued a draft list of 76 mandatory standards related to GB 9706.1-2020

Following the 6 cases reported last month, the NMPA issued another list of violations committed by medical beauty service providers in China.

New finalized emergency approval procedures for medical devices in China with scope, requirements, application procedures, etc., clarified.

According to NMPA's new classification catalogue, non-sterile liquid & paste dressings are no longer classified as a class I in China

China healthcare market update webinar was held on Dec 15, 2021, by Cisema with the EU SME Centre and the China-Britain Business Council.

New Medical Device Classification Catalogue was announced in draft on November 9, 2021, by the China NIFDC

Annual QMS self-inspection reports have new filing instructions and new report submission requirements currently in draft.