NMPA published 57 medical devices final guidelines on July 21, 2026. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission.
Impacts from the Guidelines Updates
For many manufacturers, 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 by Indications
The following 57 medical devices are categorized into FDA assigned indications.
Anesthesiology
- Low-temperature Analgesia Device
- Anesthesia Reservoir Bag
- Anesthesia Laryngoscope
- Single-use Medical Laryngeal Mask
- Single-use Suction Catheter
Cardiovascular
- Magnetocardiograph Signal Acquisition Device
- Telemetry Monitoring System
- Pulse Oximeter
Chemistry
- Lactic Acid Assay Reagent, Carbon Dioxide Assay Reagent
- N-acetyl-β-D-glucosaminidase Detection Reagent
- Adenosine Deaminase Assay Reagent
- Alanine Aminotransferase Assay Reagent
- Homocysteine Detection Reagent
- Insulin Assay Reagent
- C-peptide Assay Reagent
Dental
- Dental Implant Planning Software
- Customized Orthodontic Appliance
- Dental Implant Guide
- Temporary Crown/Bridge
- Glass Ceramic Blocks for All-ceramic Dentures
- Dental Handpiece
- Zirconia Blocks for All-ceramic Dentures
- Customized Denture
Gastroenterology and Urology
- Endoscopic Curette
- Insufflator
- Electric Gastric Lavage Machine
- Stapler
- Single-use Sterile Urinary Catheter
- Nasogastric Feeding Tube
General and Plastic Surgery
- Surgical Dissector, Hemostatic Bandage
- Medical Dressing
- Surgical Gauze Dressing
General Hospital
- Vertical Steam Sterilizer
- Medical Molecular Sieve Oxygen Generator
- Traditional Chinese Medicine Tongue Diagnosis Instrument
- Surgical Microscope
- Electric Hospital Bed
- Electric Operating Table
- Medical Electronic Thermometer
- Anti-decubitus (Pressure Ulcer) Air Mattress
Hematology
- Platelet Analyzer
- D-dimer Detection Reagent
Obstetrical and Gynecological
- Neonatal Oxygen Hood, Single-use Umbilical Cord Scissors
- Electronic Colposcope
- Umbilical Cord Dressing
Ophthalmic
- Sterile Single-use Ophthalmic Non-active Surgical Instruments
- Tonometer
Orthopedic
- Surgical Power Device
- Orthopedic External Fixator
- Bone Cement Cannula Assembly
Physical Medicine
- Medical Temperature Controller
Toxicology
- Carbamazepine Assay Reagent
- Digoxin Detection Reagent
- Valproic Acid Assay Reagent
Five Devices that Manufacturers Should Pay Close Attention
Among the 57 medical devices, many products are worthy of close regulatory monitoring by overseas manufacturers due to their large market size, high technical barriers, or strong import dependence. The following five products are particularly critical, as the issuance or revision of their registration review guidance principles will directly affect multinational companies’ business operations in China.
Magnetocardiograph Signal Acquisition Device
The MCG market is highly specialized, dominated by CardioMag Imaging and Tristan Technologies, with SQUID-based technology. NMPA’s new guideline establishes China’s first regulatory framework for this next-gen cardiac tool. Manufacturers must review shielding, algorithms, and clinical protocols. Non-compliance risks delayed entry or renewal failures in China’s growing cardiology sector.
Telemetry Monitoring System
Led by GE, Philips, and Nihon Kohden, these systems involve complex wireless data transmission. China’s new guideline tightens RF, EMC, and cybersecurity requirements. As China is a top market, overseas firms must verify interoperability and data integrity to meet local standards without disrupting clinical workflows.
Pulse Oximeter
Widely used with leaders like Masimo and Medtronic. The 2026 revision sharpens accuracy demands, especially for low perfusion and motion artifacts, plus home-use expansion. Manufacturers must confirm their proprietary algorithms (e.g., Masimo SET®) meet new benchmarks and update labeling. Non-compliance could erode trust or trigger product withdrawal in China.
Surgical Microscope
Carl Zeiss, Leica, and Olympus lead this high-value precision segment. The revised guideline now covers fluorescence imaging and 3D digital features beyond traditional optics. Overseas brands must re-assess resolution, stability, and software functions. Given premium pricing and long replacement cycles, failing to comply would jeopardize market access and reputation for surgical excellence.
Customized Denture
Though locally produced, materials and CAD/CAM systems come from global suppliers like Dentsply Sirona and Ivoclar Vivadent. The 2026 revision imposes stricter biocompatibility and digital workflow requirements. Overseas material providers must ensure their products meet new benchmarks, as any non-compliance will delay approvals for their Chinese customers, harming sales in the world’s largest dental market.