NMPA published 130 medical devices draft guidelines on September 1, 2026 for feedback. Feedbacks need to be submitted by October 8, 2026. Among them are 16 IVDs, 55 non-active, and 59 active devices. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission.
Impacts from the Guidelines Updates
When finalized, these updates may trigger the need for a regulatory gap assessment to determine whether additional actions are required, such as:
- Updated or supplemental type testing
- Revisions to Product Technical Requirements (PTRs)
- Additional nonclinical or clinical evaluation data
- Software, algorithm, cybersecurity, and interoperability documentation updates
- Biocompatibility and material assessments
- Labeling revisions and registration dossier updates
With new China GMP effective November 1, 2026, keeping up to date with your regulations and product requirements are essential. A practical assessment should assess the impact:
- Whether existing type-testing reports cover the latest technical expectations.
- Whether product technical requirements and labeling need to be updated.
- Whether additional nonclinical or clinical evidence is necessary.
- Whether software, cybersecurity, algorithms, digital workflows, or interoperability introduce new review considerations.
- Whether changes should be addressed before the next renewal or modification submission.
China Med Device, LLC has test engineers at NMPA testing centers, and seasoned clinical and regulatory staff to help you shorten your renewal or new approval time. info@ChinaMedDevice.com
Devices List
Class II IVDs
- Parathyroid Hormone Assay Reagent
- Testosterone and Free Testosterone Assay Reagent
- Thyroglobulin Assay Reagent
- Sex Hormone Binding Globulin Assay Reagent
- Butyrylcholinesterase Detection Reagent
- Lipase Assay Reagent
- 5′-Nucleotidase Assay Reagent
- Glutathione Reductase Assay Reagent
- Myeloperoxidase Detection Reagent
- Ammonia Assay Reagent
- Anti-Cardiolipin Antibody Detection Reagent
- Neisseria and Haemophilus Identification Reagent
- Monoamine Oxidase Assay Reagent
- Leucine Aminopeptidase Assay Reagent
- Trypsin Detection Reagent
- Anti-β2 Glycoprotein 1 Antibody Detection Kit
Class II Non-active Devices
- Radioactive Seed Implantation Protection Product
- Gastrointestinal Ultrasound Contrast Powder
- Electrostatic Physiotherapy Patch
- Puncture Needle
- Dilator
- Silicone Cerclage Band
- Intraocular Lens Implantation Device
- Disposable Balloon Uterine Stent
- Spinal Surgery Access Channel
- Fine-tip Puncture
- Vertebroplasty Guidance System
- Preprocessor Product
- Disposable High-Pressure Contrast Media Injection Extension Tube
- Disposable Endoscope Distal Cap Product
- Disposable Endoscope Sheath
- Tongue Depressor
- Respiratory Circuit Auxiliary Device
- Pen Injector
- Biopsy Gun
- Enteral Nutrition Device Product
- Passive Hemostatic Device
- Passive Tourniquet Product
- Disposable Gastrointestinal Tube (Red Tube) Product
- Rectal Manometry Tube
- Negative Pressure Drainage Device and Components
- Medical Drape
- Anti-Nasal Allergy Gel
- Nasal Lubricant
- Disposable Sterile Skin Roller Needle
- Intradermal Needle Product
- Disposable Human Capillary Blood Collection Container
- Gastric Occult Blood Collector
- Sample Collector Product
- Heel Lancets Product
- Seawater Nasal Wash
- Glycated Hemoglobin Chromatography Column
- Radiotherapy Patient Immobilization Device Product
- Anesthesia Waste Gas Collector
- Oxygen Supply Device
- Infant Phototherapy Protective Eye Mask
- Medical Sterile Ultrasound Coupling Pad
- Moxibustion Device Product
- Acupoint Magnetic Therapy Device
- Introducer Sheath
- Connector Valve
- Orthopedic Saw
- Annulus Fibrosus Suturing Device
- Band and Buccal Tube Product
- Conductive Paste
- Enteral Nutrition Bag
- Chest Drainage Device
- External Drainage and Suction Tube
- Surgical Non-woven Fabric Dressing
- Vaginal Packing Material
- Disposable Embedding Needle
Class II Active Devices
- Negative Pressure Source Suction Device
- Carbon Dioxide Monitor
- Otoacoustic Emission Device
- Balance Testing Equipment
- Pulse Oximetry Sensor
- Brain Electrode
- Enterodialysis Fluid Warmer
- Boiling Sterilizer
- Ozone Sterilizer
- Cardiac Rhythm Management Programmer
- Vacuum Negative Pressure Machine
- Periodontal Pocket Depth Probe
- Gynecological Examination Table
- Tinnitus Rehabilitation Device
- Infrared Thermal Imager
- Endoscope Irrigation and Suction Device
- Endoscope Distention Pump
- Electronystagmography (ENG) Device
- Medical Purification Oxygen Concentrator
- Direct Current Drug Iontophoresis Device
- Indirect Ophthalmoscope
- Cognitive Impairment Rehabilitation Device
- Visual Rehabilitation Device
- Balance Training Device
- Warm Acupuncture Treatment Device
- Moxibustion Instrument
- Thromboelastography (TEG) Analyzer
- Blood Cell Morphology Analyzer
- Flow Cytometer
- Electrolyte Analyzer (Volumetric Pressure Method)
- Microbial Culture Monitoring Instrument
- Bacterial Endotoxin Detector
- Helicobacter Pylori Analyzer
- Image Scanning Instrument
- Urine Analysis System
- Osmometer
- Electronic Thermometer
- Exhaled Nitric Oxide Analyzer
- Electroglottograph
- Otoacoustic Impedance Meter (Tympanometer)
- Thyroid Function Test Instrument
- Ethylene Oxide Sterilizer
- Pacemaker System Analyzer
- Non-invasive Ventilator
- Electric Diagnosis and Treatment Table
- Dental Lighting Equipment
- Vibration Training Equipment
- Medical Centrifugal Oxygen Separation System
- Traditional Chinese Medicine Auxiliary Diagnosis Software
- Syringe Auxiliary Pushing Device
- Body Composition Analysis Device
- Biochemical Analyzer
- Microbial Identification and Antimicrobial Susceptibility Analyzer
- Urine Analyzer
- Gamma Radioimmunoassay Counter
- Stool Analyzer
- Sperm Quality Analyzer
- Reproductive Tract Secretion Analyzer
- Biochip Analyzer