NMPA Releases 46 Medical Device Industry Standards Including "Dentistry — Curing Lights"

On August 14, 2026, the National Medical Products Administration (NMPA) officially issued Announcement No. 76 of 2026, releasing 46 medical device industry standards, including YY 0055—2026 "Dentistry — Curing Lights."

The 46 standards cover multiple high-end and high-risk medical device technology areas, including new biomaterials, life support systems, and surgical implants, as well as common methodological fields such as medical device biological evaluation and software graphic measurement functions — all aimed at better supporting the development of the medical device industry and regulatory needs.

Standard Breakdown:

l 2 Mandatory Standards: "Dentistry — Curing Lights" and "Extracorporeal Circulation Systems — Extracorporeal Cardiopulmonary Support Equipment," effective August 1, 2029

l 2 Recommended Standards: "Dentistry — Oral Digital Observers" and "Dentistry — Root Canal Instruments — Part 4: Auxiliary Instruments," effective February 1, 2028

l 42 Recommended Standards: Including "Dentistry — Refractory Investment and Die Materials" and "Single-use Gastrointestinal Nutritional Systems," effective August 1, 2027

Revisions vs. New Standards:

l 22 Revised Standards: Integrating previous standards, improving core technical content, and updating technical indicators to strengthen product quality assurance

l 24 Newly Developed Standards: Addressing urgent industry and regulatory needs, providing specifications for R&D, production, and testing of related products

Notably, the development of "Absorbable Medical Biomaterials — Poly(p-dioxanone)" (YY/T 2023—2026) fills the gap of no unified industry standard for this new biomaterial in China, strengthening quality control from the upstream raw material stage."Medical Additive Manufacturing — Requirements for Reuse of Metal Powders" (YY/T 2024—2026) provides reliable solutions for manufacturers facing challenges in powder reuse, including unclear methods, validation indicators, and risk identification.