Fifteen newly established or revised industry standards were released by NMPA on October 30, 2025, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions.
The standards will be implemented on November 1, 2026.
Significance of Compliance
Industry mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.
The industry recommended standards are not legally binding but highly recommended by regulatory authorities.
Below are all recommended standards. For an English copy, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
Standards by Indications
Radiology
- Medical electrical equipment — Medical imaging display systems — Part 2: Acceptance and constancy tests for medical imaging display systems
Dentistry
- Dentistry — Orthodontic brackets and buccal tubes
- Dentistry — Magnetic attachments
- Dentistry — Zirconia dental implants — Dynamic fatigue test
Infusion
- Portable electric infusion pumps
Laboratory
- Medical clean bench
Neurology
- Evaluation of neurotoxicity for medical devices — Part 2: Neurocytotoxicity test
Orthopedic Implants
- Sports medicine implants — Meniscal repair systems
Assisted Reproduction
- Medical devices for assisted reproduction — Determination of sucrose, glucose, trehalose, and fructose in media for assisted reproduction
Digital Pathology
- Artificial intelligence medical devices — Cytopathology image-assisted analysis software — Algorithm performance testing methods