NMPA published 39 medical devices final guidelines on December 1, 2025. They are aimed to facilitate manufacturers with clarity in registration process.
Significance of Device Guidelines
The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities.
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines. As a result, approved products still need to go through local type testing to show that they are current with these new requirements.
China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.
Full List
The release of such a large number of guidelines within a single day is highly meaningful. It signals an accelerated effort by the authority to modernize China’s medical device regulatory framework. By simultaneously issuing guidance documents covering a broad spectrum of medical devices—from cardiovascular monitors, endoscopic and laparoscopic instruments, and physical therapy equipment to ophthalmic analyzers, obstetrical and gynecological devices, and immunoassay reagents—NMPA is clearly emphasizing standardization and regulatory clarity, promoting alignment with international practices, especially for products demanding high clinical precision and technical sophistication.
For English version of any draft guidelines below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation. We will also give you the email and phone number of contact person that NMPA assigned for the guideline.
The guidelines concern the devices below, categorized by FDA indications:
Cardiovascular
- Single-use ECG electrodes
- Electrocardiograph
- Holter electrocardiograph (dynamic ECG)
- Ambulatory blood pressure monitor
- Patient monitoring products (Class II)
- Infusion pump
- Central monitoring software
- Cardiac troponin I / myoglobin / CK-MB test (colloidal gold)
- Balloon inflation device for intravascular balloon dilation catheters
Chemistry
- High-density lipoprotein cholesterol assay
- Electrolytes (K, Na, Cl, Ca) assay
- Cystatin C assay
Dental
- Ultrasonic scaler
Ear, Nose, and Throat (ENT)
- Infrared ear thermometer
Gastroenterology and Urology
- Flexible fiber endoscope
- Rigid optical endoscope (natural orifice type)
- Uterine–fallopian tube hysterosalpingography balloon catheter (crosses into OB/GYN)
General and Plastic Surgery
- Surgical shadowless lamp
- Laparoscopic surgical instruments (Class II)
General Hospital
- Medical electric suction device
- Small steam sterilizer
- Electric wheelchair
Immunology
- Luteinizing hormone test (colloidal gold)
- Enzyme-linked immunoassay analyzer
Obstetrical and Gynecological
- Ultrasound Doppler fetal monitor
- Ultrasound Doppler fetal heart rate monitor
- Uterine–fallopian tube hysterosalpingography balloon catheter
- Medical ozone gynecological therapy device
Ophthalmic
- Perimeter (visual field analyzer)
- Slit-lamp microscope
- Refractor (optometry device)
Physical Medicine (Physical Therapy & Rehab)
- Electric traction device
- Intermediate-frequency electrotherapy products
- Infrared therapy equipment
- Ultraviolet therapy equipment
- Visible spectrum therapeutic device
- Semiconductor laser therapy device (Class II)
- Ultrasound physiotherapy device
Radiology
- Infrared breast inspection device
- Ultrasound bone densitometer