Medicalequipment. For example, Indonesia has the SNI certification, Thailand has the TISI certification, and the Philippines has the BPS certification. It is necessary to confirm in advance the equipment voltage (such as 380V/50Hz in Thailand), the compatibility of the CE certification, and the proof of environmentally friendly materials.Qualification access standards

According to the1. VerifyMedical EquipmentClassification Catalog (Revised Edition), importers must pay special attention to three types of changes:

• 7 new Class II controlled varieties added for diagnostic reagents
• Imaging equipment resolution standards upgraded to 0.3mm
• Additional biocompatibility testing requirements for implantable devices

Three core documents must be completed during the qualification preparation stage:

• Verification of validity period for Imported Medical Device Registration Certificate,
  • Remaining validity period of registration certificate must exceed 6 months
  • Completeness verification of attached technical evaluation reports
• ManufacturerISO 13485 certificationDocument notarization
• Import RepresentationFiling of Medical Device Business License

Key points of customs clearance operations

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

• 100% unpacking inspection for equipment with unit price exceeding $200,000
• Equipment containing radioactive components requiresRadiation Safety License
• AI diagnostic equipment requires supplementary algorithm source code filing

Special attention required during customs clearance:

• HS Code confirmation
  • Medical ultrasound equipment classified under 9018.1210 rather than general electronic equipment
  • Matching reagents need to be declared separately under pharmaceutical tariff codes
• Inspection and quarantine documents
  • Sterilization equipment requires accompanying foreign official health certificates
  • Equipment containing biological materials requiresspecial article approval certificates

Special equipment logistics management standards

Considering the special nature of medical equipment, a three-level logistics guarantee system must be established:

• Temperature-controlled equipment transportation standards
  • MRI superconducting coils maintaining -269℃ liquid helium environment
  • In vitro diagnostic reagents require 2-8℃ cold chain monitoring throughout transportation
• Shockproof Packaging Certification
  • CT machine gyroscope transportation must pass ISTA 3E testing
  • Special cushioning materials for surgical robot joint parts

Key points of post-sales compliance management

Legal procedures required after equipment delivery:

• Complete Imported Medical Device Usage Registration within 30 days
• Adverse event monitoring report during first year of use
• Annual cybersecurity self-inspection filing for software-based equipment

Recommendations based on frequent typical cases in recent years:

• Avoid declaring medical equipment under trading company names
• Refurbished used equipment imports require advance processingMedical device re-registration
• Clinical trial equipment separate application for temporary import permit