On March 24, 2026, NMPA published draft versions of registration review key points for 18 medical devices. Once finalized, the documents aim to provide manufacturers with clearer guidance on testing, clinical evaluation and registration requirements.
This marks the second time that feedback has been sought for the key points concerning tumor gene variation detection reagents, with comments due by April 8, 2026. For all other documents, feedback must be submitted by April 27, 2026.
NMPA issued clinical evaluation guideline for cancer screening IVDs. Click HERE for the key requirements and global implications
For NMPA reviewer’s opinion on Colorectal cancer detection kit, please click HERE
The key points were prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities.
Full List
The release of such a large number of draft documents 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 these documents covering a broad spectrum of medical devices—from molecular diagnostics, anesthesiology, and cardiovascular products to orthopedics and ear, nose, and throat devices—NMPA is clearly emphasizing standardization and regulatory clarity, promoting alignment with international practices, especially for products demanding high clinical precision and technical sophistication.
The documents cover the devices below, categorized by FDA indications:
Molecular Diagnostics
- Tumor Gene Variation Detection Reagents
- Hepatitis B Virus Pre-S2 Antigen Detection Kit (Magnetic Particle Chemiluminescence Method)
- Combined Nucleic Acid Detection Kit for Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae
Anesthesiology
- Infusion Pump with Target-Controlled Infusion Function
Cardiovascular
- Temporary Cardiac Pacing Lead
- Intravascular Shockwave Therapy Device
- Implantable Cardiac Contractility Modulator
Ear, Nose, and Throat (ENT)
- Audiometry Device
General and Plastic Surgery
- Absorbable Surgical Suture (with Triclosan Coating)
- Medical Sealing Adhesive
General Hospital
- Mobile Magnetic Resonance Imaging System
- Single-Use Hemoperfusion Device
Immunology
- Biotin Interference-Related Study Materials (Involving In Vitro Diagnostic Devices/Reagents)
- Hepatitis B Virus Pre-S2 Antigen Detection Kit (Magnetic Particle Chemiluminescence Method)
Microbiology
- Combined Nucleic Acid Detection Kit for Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae
Neurology
- Implantable Neurostimulation Electrode
- Neuromodulation Pressure Controller
Orthopedic
- Additively Manufactured Polyetheretherketone Bioceramic Composite Cranial Repair Prosthesis System
- Additively Manufactured Absorbable Composite Bone Repair Material
- Additively Manufactured Bioceramic Bone Filling Material