NMPA issued the “2026 Medical Device Industry Standards Revisions Plan” today on January 28, 2026. One mandatory and seventy-nine recommended standards will be revised or established. The standards revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards.
Two English written standards in the field of genetic testing are included in the plan, reflecting the continued advancement and regulatory scrutiny in the space.
Legally Binding
Industry Mandatory Standardsare legally enforced.Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.
The industry recommended standards are not legally binding but recommended by regulatory authorities.
Huge Impact
Whether you are renewing or submitting new registration, your medical devices need to meet these new standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new standards. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new standards. 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.
Mandatory standard
- Water-based Dental Cements — Part 1: Acid-base Cements
The mandatory standard is originally implemented in June 2028 and to be revised after the release of international counterpart of ISO 9917-1:20251.
Recommended Standards
1. Tissue Engineering & Regenerative Medicine
• Tissue-engineered Medical Products — Cartilage MRI Evaluation — Part 1: Clinical Evaluation of Regenerated Knee Cartilage Using dGEMRIC and T2 Mapping
• Evaluation Method for Collagen Regeneration Performance and In Vivo Degradation Rate of Facial Soft Tissue Fillers Containing Biodegradable Microparticles
2. Biological Safety, Toxicology & Preclinical Evaluation
• Immunotoxicity Testing of Recombinant Collagen Proteins
• Biological Evaluation of Nanomedical Devices — Genotoxicity Testing — In Vitro Mouse Lymphoma
• Preclinical Animal Study of Medical Devices — Part 5: Rat Cecum–Abdominal Wall Adhesion Model
• Immunogenicity Evaluation of Medical Devices — Part 1: In Vitro T Lymphocyte Transformation Test
• Standard Test Model for Performance Evaluation of Contact Wound Dressings — Part 2: Animal Burn Model for Evaluating Wound Healing Promotion
3. Assisted Reproduction & Laboratory Equipment
• Medical Devices for Human Assisted Reproductive Technology — Time-lapse Incubator
• Medical Carbon Dioxide Incubator
4. Additive Manufacturing & Biomaterials
• Medical-grade Polylactic Acid and Its Copolymer Materials for Additive Manufacturing
• Characterization Methods for Micro- and Nano-structural Features of Porous Bioceramics
• Polycarbonate Resin Materials for Infusion, Transfusion, Injection and Other Medical Devices
5. Artificial Intelligence & Software as Medical Device
• Artificial Intelligence Medical Devices — Dataset-specific Requirements: Electrocardiogram (ECG)
6. Surgical Navigation, Robotics & Therapy Devices
• Medical Electrical Equipment Using Robotic Technology — Requirements and Test Methods for
• Steep Pulse Therapy Equipment
• Laser Therapy Equipment — Thulium-doped Fiber Laser Therapy System
7. Genomics, Sequencing & Molecular Diagnostics
• Technical Guideline for High-throughput Sequencing Analysis of Tumor Microsatellite Instability
• Technical Specification for High-throughput Sequencing Library Construction for Tumor Mutation Detection
• Technical Requirements for Metagenomic Sequencing of Bloodstream Infection Pathogens
• Cybersecurity Risk Considerations and Testing Guideline for Gene Sequencers
• Fully Automated Sequencing Library Preparation System
• High-throughput Gene Sequencer
8. UDI & Real-world Data
• Guideline for the Application of Unique Device Identification (UDI) for Medical Devices
• General Quality Requirements for Real-world Data of Medical Devices
9. Diagnostic Imaging
• Performance and Test Methods for Positron Emission and X-ray Computed Tomography Systems (PET/CT)
• Performance and Test Methods for Single Photon Emission and X-ray Computed Tomography Systems (SPECT/CT)
• Special Technical Requirements for Digital Radiography X-ray Systems
• Image Quality Evaluation Methods for X-ray Computed Tomography Equipment — Part 5: Temporal Resolution Evaluation
• General Technical Requirements for Diagnostic X-ray Tube Assemblies
MRI & Ultrasound
• Measurement of Spectroscopic Quality Parameters of Medical MRI Systems
• General Technical Requirements for Intracardiac Ultrasound Diagnostic Equipment
10. In Vitro Diagnostics (IVD)
• Purified Water for In Vitro Diagnostic Reagents
• Implementation Guideline for Establishing Metrological Traceability — Part 2: Traceability to International Calibrators or Reference Materials
• Implementation Guideline for Establishing Metrological Traceability — Part 3: Traceability to
• Free Prostate-specific Antigen (fPSA) Assay Kit
• Mycobacterium tuberculosis Complex and Drug Resistance Gene Mutation Detection Kit
• Valproic Acid Assay Kit
• Renin Assay Kit (Chemiluminescence Immunoassay)
• Rheumatoid Factor Assay Kit
• Alpha-1 Microglobulin Assay Kit (Immunoturbidimetric Method)
• Free Estriol Assay Kit (Labeled Immunoassay)
• Gastrin-17 Assay Kit (Labeled Immunoassay)
11. Respiratory, Emergency & Monitoring Devices
• Reliability Verification Method for Emergency Ventilators
• Polysomnography System
• Thromboelastography Analyzer
12. Surgical Instruments & Consumables
• Barbed Surgical Sutures
• Disposable Laparoscopic Specimen Retrieval Bag
• Test Method for Triclosan Content in Surgical Sutures
• Electronic and Electromechanical Pen-type Injection Systems — Requirements and Test Methods — Part 4
• Vertebral Kyphoplasty Balloon Dilatation Catheter
• Disposable Centrifugal Blood Component Separator
• Disposable Capillary Blood Collection Tube
13. Suction & Fluid Management Devices
• Medical Suction Equipment — Part 1: Electrically Powered Suction Devices
• Medical Suction Equipment — Part 2: Manually Powered Suction Devices
• Medical Suction Equipment — Part 3: Vacuum or Pressure Source-driven Suction Devices
• Medical Suction Equipment — Part 4: General Requirements
• Ultrasonic Surgical Aspirator
14. Cardiovascular & Orthopedic Implants
• Intravascular Devices — Part 3: Vena Cava Filters
• Fatigue Test Methods for Cardiac Valve Clip Systems
• Knee Joint Prosthesis — Performance Evaluation Requirements
• Radial Head Prosthesis System
15. Aesthetic & Gynecological Devices
• Anti-human Papillomavirus (HPV) Medical Gel
16. Dentistry & Oral Implants
• Sinus Lift Elevator
• Dental Elevator
• Dental Bone Graft Materials
• Preclinical Evaluation of Osteogenic Performance of Dental Barrier Membranes
• In Vivo Degradation Evaluation of Absorbable Dental Devices
• Digitally Manufactured Titanium Mesh for Dentistry
17. Dialysis & Blood Purification
• Water Treatment Equipment for Hemodialysis and Related Therapies
• Dialysate Quality for Hemodialysis and Related Therapies
• Disposable Hemoperfusion Cartridge
18. Packaging & Sterilization Validation
• Sterile Medical Device Packaging Test Methods — Part 1: Accelerated Aging Test Guide
• Sterile Medical Device Packaging Test Methods — Part 17: Microbial Barrier Test Using Aerosol Filtration Method for Breathable Packaging Materia
19. Reliability Engineering
• Reliability Modeling, Prediction and Allocation Methods for Active Medical Devices
English Written Standards
- Gene mutation in tumor tissue detection kit (high-throughput sequencing)
- Software of human embryo preimplantation genetic testing for chromosome aneuploidy analysis