In China, intraoral scanners are classified as Class II medical devices. Both manufacturers and sellers must hold the proper licenses, and clinics should carefully verify these credentials before purchase to ensure legal use and patient safety.
Regulatory Basis (China)
According to the Medical Device Classification Catalog, intraoral scanners (oral digital impression devices) fall under Class II medical devices, classification code 17-06-04 (oral functional auxiliary equipment).
Manufacturers must hold a Medical Device Production License.
The product itself must obtain a registration certificate from the National Medical Products Administration (NMPA).
Distributors must hold a Class II Medical Device Business Filing Certificate.
Credentials Clinics Must Verify Before Purchase
Medical Device Registration Certificate
Confirm that the product name, model, and manufacturer exactly match the physical unit, and that the certificate is still valid. Verification is possible on the official NMPA website.
Manufacturer's Business License and Production License
Distributor's Class II Medical Device Business Filing Certificate
Product Technical Requirements
The technical parameters approved during registration.
Inspection / Test Report
Official registration testing report issued by a recognized medical device testing institution.
Instructions for Use and Labeling
Must include Chinese labeling and instructions showing the registration number, manufacturer, production date, and other required information.
Electrical Safety Certification
Compliance with standards such as GB 9706.1 for medical electrical equipment safety.
Biocompatibility Evaluation
Because the scanning tip contacts oral mucosa, the device must pass biocompatibility testing (cytotoxicity, sensitization, and irritation).
Important Precautions
Never purchase "gray market," parallel-import, or overseas-only units that lack Chinese labeling and a valid NMPA registration certificate. Such devices cannot be used legally and have no after-sales support.
Even if a brand is well-known internationally, specific overseas models may not hold Chinese registration and therefore cannot be legally sold or used in China.
The exact model listed on the registration certificate must match the unit being purchased. Different models within the same series may require separate registrations.
Software updates must not alter the approved scope of use stated on the registration certificate.
Clinics should keep copies of the supplier's qualifications and the product registration certificate for regulatory inspections.
Export Certifications (for International Reference)
Manufacturers targeting global markets typically obtain:
FDA (United States): 510(k) clearance
CE (European Union): MDR CE marking
Other common certifications: Canada MDL, Australia TGA, Japan PMDA, Korea MFDS (formerly KFDA), etc.
Aident Technology holds Class II medical device qualifications in China and CE certification for its intraoral scanners. The AI-30 series is designed to meet applicable safety, biocompatibility, and quality standards while providing open-architecture performance (STL/PLY/OBJ export) and lifetime free software updates.
For product registration details, compliance documentation, or to request a quote and demo, visit:
https://www.aident3d.com/3d-scanner/intraoral-scanner/
or contact the team at https://www.aident3d.com/inquiry / https://www.aident3d.com/certificate
Purchasing only properly registered and certified equipment protects your clinic from regulatory risk, ensures patient safety, and guarantees access to legitimate technical support and warranty service. Always verify the full set of credentials before signing any purchase contract.
