May 2021 China Regulatory Round-up for Medical Devices guidelines

The NMPA (National Medical Products Administration) announced plans to write 5 new technical guidelines whilst there were 4 medical device guidelines implemented and 6 drafts issued to solicitate for public comments.

On April 16, 2021, the Center for Medical Device Standardization Administration of the NMPA (National Medical Products Administration) issued the drafts of 4 regulatory guidelines:

• Guidelines for the Classification of Radio Frequency Beauty Products (Draft)
• Guidelines for the Classification of Artificial Intelligence Medical Software Products (Draft)
• Guidelines for the Classification of Sports Rehabilitation Training Products (Draft)
• Guidelines for the Classification of Drug-Device Combination Products (Draft)

In April and May, the CMDE (Center for Medical Device Evaluation) of the NMPA announced their plans to write the following technical guidelines:

Date of AnnouncementName of Technical GuidelinesApril 28, 2021Technical Guidelines of Epstein-Barr Virus (EBV) Test Reagents  April 28, 2021Technical Guidelines of Hepatitis E Virus (HEV) IgG/IgM Antibody Tests  April 28, 2021Technical Guideline for the Development of Reference Intervals (RI)  April 30, 2021Technical Guidelines of Additive Manufacturing on Polyether ether ketone (PEEK) Implants  May 7, 2021Technical Guidelines for the Clinical Evaluation of Products with Oral Navigation System Applications

On May 7, 2021, the CMDE of the NMPA also issued the drafts of the following technical guidelines:

• Technical Guidelines for Microcatheters
• Technical Guidelines for Intraocular Lens

On May 8, the NMPA announced the implementation of the following technical guidelines:

• Technical Guidelines for Dental Glass Ionomer Cement
• Technical Guidelines for Citric Acid Disinfectants
• Technical Guidelines for Single Use Pen Needles
• Technical Guidelines for Disposable Sterile Ligating Clips

By Jacky Li. Contact Cisema if you would like to learn more.