Medical Devices

9 product categories have been reported by the NMPA for not meeting the standard requirements whilst 12 regulatory guidelines and drafts have been issued.

According to the announcement published by the Centre for Medical Device Evaluation) of the National Medical Products Administration on April 12, 2021...

The announcement cover details of the working procedures and appendices for quality spot checks and inspection procedures for medical devices within China.

Inspection work shall be carried out in accordance with the mandatory standards or product technical requirements for post-market activities in China.

The Guangdong MPA announced the first approved medical device arriving the University of Hong Kong – Shenzhen Hospital via the Greater Bay Area initiative.

22 technical guidelines (draft) were issued in March 2021, and technical guidelines for products monitoring non-invasive blood / glucose will be drafted

The NHC announced the implementation of The Administrative Measures for the Clinical Use of Medical Devices coming into force from March 1, 2021 onwards.

The Guangdong MPA (Medical Products Administration) announced details about the pilot plan and the responsibilities of different departments involved.

The NMPA announced the implementation of a mNMPA Introduces the Medical Device Master Filing System covering both medical devices and IVDs.

The NMPA announced a total of 28 updates on the classification catalogue for medical devices including 15 classification changes and 13 content updates.

6 technical guidelines & 4 GB / YY draft standards were announced; 2 products registered & 7 applications accepted by the fast-track approval pathway.

On February 5, the NMPA issued a report covering a breakdown of the total existing and new standards for medical devices in 2020.