MedicalEquipment ImportsQualification access standards

According to the regulations that will take effect in 2025,1. VerifyMedical EquipmentCatalog of Categories (Revised Edition)Importers must pay special attention to three types of changes:

• Seven new Class II controlled diagnostic reagents have been added.
• The resolution standard for imaging equipment has been upgraded to 0.3mm.
• Implantable devices require additional biocompatibility testing.

During the qualification preparation phase, three core documents must be completed:

• Verification of the Validity Period of the "Registration Certificate for Imported Medical Devices"
  • The remaining validity period of the registration certificate must be more than 6 months.
  • Attached technical review report integrity verification
• ManufacturerISO 13485 CertificationNotarization of documents
• Import RepresentationFiling of the "Medical Device Business License" for Commerce

Key Points in Customs Clearance Practical Operations

Customs will implement new inspection rules for medical equipment in 2025:

• Equipment with a unit price exceeding $200,000 is subject to 100% unpacking inspection.
• Equipment containing radioactive components must be provided.Radiation Safety License
• The AI diagnostic device requires supplementary filing of the algorithm source code.

Special attention is required during the customs clearance process:

• HS Code confirmation
  • Medical ultrasonic equipment is classified under 9018.1210 rather than general electronic devices.
  • Supporting reagents must be declared under a separate drug tariff code.
• Inspection and quarantine documents
  • Disinfection equipment must be accompanied by an official foreign health certificate.
  • Equipment containing biological materials requires processing.Special Item Approval Form

Specifications for Special Equipment Logistics Management

Given the unique characteristics of medical equipment, a three-tier logistics support system must be established:

• Transportation Standards for Temperature Control Equipment
  • Please translate the following Chinese into English: MRI superconducting coils maintain a liquid helium environment at -269°C.
  • In vitro diagnostic reagents 2-8°C cold chain full-process monitoring
• Shockproof Packaging Certification
  • The gyroscope for CT machines must pass the ISTA 3E test during transportation.
  • Specialized cushioning material for surgical robot joint components

Key Points of After-Sales Compliance Management

Legal procedures to be completed after equipment delivery:

• Complete the "Registration for the Use of Imported Medical Devices" within 30 days.
• Adverse Event Monitoring Report During the First Year of Use
• Annual Cybersecurity Self-Inspection and Filing for Software-Based Equipment

Suggestions for addressing the frequent occurrence of typical cases in recent years:

• Avoid using the letterhead of a trading company to declare medical equipment.
• The import of refurbished equipment requires prior processing.Medical Device Re-registration
• Apply for a temporary import permit for clinical trial equipment separately.