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 Announcement | Name of Technical Guidelines |
| April 28, 2021 | Technical Guidelines of Epstein-Barr Virus (EBV) Test Reagents |
| April 28, 2021 | Technical Guidelines of Hepatitis E Virus (HEV) IgG/IgM Antibody Tests |
| April 28, 2021 | Technical Guideline for the Development of Reference Intervals (RI) |
| April 30, 2021 | Technical Guidelines of Additive Manufacturing on Polyether ether ketone (PEEK) Implants |
| May 7, 2021 | Technical 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.
