NMPA published the “2025 Medical Device Guidelines Revisions Plan” on May 7, 2025, in which 55 guidelines for Class III and 55 for Class II devices are affected. The revisions are aimed to facilitate manufacturers with more guidance and clarity in registration process.
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
The List
The plan involves newly-established and revised guidelines. It includes but is not limited to the following. For the full list please contact info@ChinaMedDevice.com
Class III Devices
- Medical Device Modeling and Simulation Technology
- CT Tube Reliability Evaluation
- Drug Infusion Pump Usability
- Monitoring Device Alarm Technology
- Cryoablation Therapy Device
- Surgical Navigation and Positioning System
- Medical Electron Linear Accelerator
- Gamma Beam Radiotherapy System
- Fractional Flow Reserve (FFR) Products
- Hemodynamic Monitoring Device
- Infant Incubator
- Continuous Renal Replacement Therapy (CRRT) Device
- Implantable Deep Brain Stimulator
- Infant Radiant Warmer
- Cardiac Electrophysiological Mapping Device and Accessories
- Intravascular Ultrasound (IVUS) Diagnostic Device
- Cardiac Pulsed Field Ablation Device
- Laparoscopic Endoscopic Surgical System (Part 6: Model Studies)
- Orthokeratology (Ortho-K) Lenses
- Glaucoma Drainage Device
- Light-Curable Calcium Hydroxide Indirect Pulp Capping Agent
- Meniscus Suture System
- Craniomaxillofacial Internal Fixation System
- Orthodontic Anchorage Screw
- Elbow Prosthesis System
- Absorbable Ligation Clip
- Breast Biopsy Needle and Accessories
- Single-Use Peripheral Nerve Block Needle
- Single-Use Dialysis Indwelling Needle
- Plasma Separator
- CYP2C9 and VKORC1 Gene Polymorphism Detection Reagent
- Digital PCR Analyzer
- Tumor-Associated Gene Detection Reagent (Cut-off Value Study)
- Carbapenem-Resistant KPC Gene Detection Reagent
- HLA-B*5801 Gene Detection Reagent
- Radiotherapy Image-Guided Device (Clinical Evaluation)
- Intraocular Lens (Clinical Evaluation)
- Implantable Deep Brain Stimulation System (Clinical Trial)
- Knee Cartilage Repair Device (Clinical Trial)
- Flow Diverter Stent (Clinical Trial)
- Hyperbaric Oxygen Chamber
Class II Devices
- Magnetocardiography (MCG) Signal Acquisition Device
- Vertical Pressure Steam Sterilizer
- Telemetry Monitoring System
- Cryo-Impact Analgesia Device (Cold Air Therapy Unit)
- Anesthesia Reservoir Bag
- Digital Implant Design Software
- … …