NMPA published the “2026 Medical Device Guidelines Revisions Plan” on April 27, 2026, affecting 56 Class III and 219 Class II devices. The revisions are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission.
Significance of NMPA Guidelines
The guidelines are introduced by NMPA Center of Medical Device Evaluation (CMDE). It is not legally binding but highly recommended by regulatory authorities. The revision plan will not only impact the new product registration but also renewals and modifications. It involves type testing, clinical, registration review guidelines, technical guidelines, e.g., Real World Study design, and documentation guidelines, e.g., Indication for Use (IFU) writing.
NMPA issues new or updated guidelines throughout the year. Given their importance in understanding what the NMPA reviewers are looking for, it is essential that manufacturers keep up to date with the guidelines that are latest to their specific products. One source to get updates on these guidelines is through our complimentary monthly news roundup that you can opt in from our website www.ChinaMedDevice.com
Class III Devices List
The revisions plan involves newly-established and revised guidelines. The scope for the Class III devices is broad, including high-risk devices such as implantable neurostimulation electrodes, artificial vascular grafts, left ventricular assist systems, and other cardiovascular and neuromodulation devices; oncological treatment equipment such as picosecond Nd:YAG laser therapy systems and femtosecond laser systems; interventional consumables such as embolic microspheres and intracranial liquid embolic devices; recombinant collagen products for plastic surgery; and various IVD reagents (e.g., HIV self-test kits, cervical cancer methylation test kits, high-throughput sequencing tumor gene test kits, etc.)
We have categorized the guidelines based on FDA assigned indication. For an English version of any guidelines below, please contact info@ChinaMedDevice.com
Cardiovascular
– Anastomotic Reinforcement Patch
– Special Structure Balloon Dilatation Catheter
– Peripheral Thrombus Aspiration Catheter
– Embolic Microsphere
– Cardioplegia Perfusion Device
– Single-use Arteriovenous Cannula
– Artificial Vascular Graft Clinical Trial
– Embolic Microsphere Same-type Clinical Evaluation
– Intravascular Shockwave Therapy System Clinical Trial
– Implantable Left Ventricular Assist System
Dental
– Gingival Retraction Material
– Tooth Whitening Product
– Dental Abutment
– Customized Abutment Crown Bridge
– Denture Base Polymer Material
General and Plastic Surgery
– Breast Lesion Rotational Biopsy Device
– Laser Photodynamic Therapy Device
– Picosecond Nd:YAG Laser Therapy Device
– Recombinant Collagen Product for Plastic Surgery
– Breast Tissue Marker
– Medical Sealant
– Medical Radiofrequency Therapy Device Clinical Trial
– Laparoscopic Surgical Robot System Clinical Evaluation
– Alpha-cyanoacrylate Medical Adhesive
– Hernia Repair Mesh Clinical Trial
General Hospital
– Hyperbaric Oxygen Chamber
– Insulin Pump Reservoir
– Single-use Multi-needle Injection Needle
– Insulin Pump Subcutaneous Infusion Set
– Biological Evaluation of Dressing Products
– Active Medical Device Service Life
– Artificial Intelligence Medical Device
– Absorbable Hemostatic Product
Immunology
– HIV Antibody Self-test Kit Clinical Trial
– Anti-human Globulin Test Kit
– Mycobacterium Tuberculosis Specific Cell Immune Response Test Kit
Microbiology
– Treponema Pallidum Antibody Test Kit
– Ureaplasma Urealyticum Nucleic Acid Test Kit
– Norovirus Nucleic Acid Test Kit Preclinical Study
– Hepatitis B Surface Antigen Test Kit
– Respiratory Virus Antigen Self-test Kit Clinical Trial
– Helicobacter Pylori Antigen/Antibody Test Kit
– Enterovirus Nucleic Acid Test Kit
Neurology
– Implantable Neurostimulation Electrode
– Neuroregulation Programmable Charger
– Intracranial Liquid Embolic Device
– Skull Clip/Lock
Ophthalmic
– Femtosecond Laser Therapy System Clinical Evaluation
Orthopedic
– Patella Claw
– Partial Knee Prosthesis
Radiology
– Patient Positioning System for Radiotherapy
– AI-assisted Diagnostic Medical Device Clinical Evaluation
– AI Multi-classification Assisted Decision Medical Device Clinical Evaluation
Molecular Diagnostics
– Cervical Cancer Methylation Test Kit
– Tumor Associated Mutation Gene Test Kit (High-throughput Sequencing)