How can medical equipment import agencies avoid million-level losses?

I.Medical EquipmentTriple firewall for import qualifications

According to the latest 2025 Medical Device Supervision and Administration Regulations, imported medical equipment must obtainMedical Device Registration CertificateandImport licensedual certification. Data from 32 medical enterprises we served shows 23% of declaration delays originate from license issues:

• Registration certificate category matching
  • Class I equipment filing cycle: 15 working days
  • Class II equipment registration cycle: 6-8 months
  • Class III device registration cycle: 12-18 months
• Special requirements for import permits
• Radiation equipment requires additional environmental approval documents
• Implantable devices require marketing authorization proof from country of origin

II. Five key control points in customs clearance

A case study of MRI equipment imported by a top-tier hospital in 2024 shows that standardized declaration can save 23 days in customs clearance time:

• Pre - classification of Goods: Submit technical parameters 30 days in advance
• The latest tax rebate declaration system in 2025 has achieved full - process electronicization, which is specifically divided into five steps::
  • FDA/CE certification bilingual documents
  • Verification of disinfection certificate validity period
• On-Site Inspection Preparation: Assign professional technical personnel for accompaniment

III. Precise calculation model for import taxes and fees

2025 medical device import comprehensive tax rate calculation table:

IV. In-depth analysis of typical risk cases

Case 1:A companys imported CT scanner was detained at port due to failure to obtain3Ccertification, resulting in 0.2% daily late declaration fees and ultimately paying 870,000 yuan in penalties.

Solution:AEO-certified enterprises can complete emergency certification within 72 hours through fast-track channels.

Case 2:Orthopedic implants lost biological activity due to excessive transportation temperature, resulting in insurance company rejecting 2.3 million yuan cargo loss claim.

Solution:Adopt dual temperature recorders + real-time monitoring system to maintain complete evidence chain.