NMPA Releases 38 Medical Device Industry Standards

The NMPA published YY 0300-2025 "Dentistry – Artificial Teeth for Restoration" and 37 other medical device industry standards, specifying standard numbers, names, scopes of application, and implementation dates.

Scope of Standards: The 38 industry standards cover multiple domains including dentistry, traditional Chinese medicine devices, in vitro diagnostic reagents, and robotics.

New Standards (25 items) include:

17α-hydroxyprogesterone assay kit (labeled immunoassay)

Intraoral digital X-ray imaging system technical specifications

Medical lower limb exoskeleton robot

Revised Standards (13 items) include:

Dentistry – Metal-ceramic and ceramic-ceramic system compatibility tests

Traditional Chinese medicine devices – Electro-acupuncture therapy devices

Surgical implants – Active implantable medical devices – Part 6: Special requirements for active implantable medical devices treating tachyarrhythmia (including implantable defibrillators)

Implementation Schedule:

July 1, 2026: 26 standards (including X-ray CT equipment general technical conditions, ophthalmic instruments projection and electronic visual acuity charts)

January 1, 2027: 4 standards (including steam formaldehyde sterilizers, peritoneal dialysis equipment)

July 1, 2027: 2 standards (including blood thawing equipment, dentistry multifunctional spray guns)

July 1, 2028: 6 standards (including dentistry polymer-based crowns and veneer materials, cardiopulmonary bypass single-use arteriovenous cannulas)