MedicalEquipment ImportsThree Major Characteristics and Four Key Challenges

Unlike ordinary commodity imports, medical devices are subject to strict global regulation due to their direct impact on public health safety. After the implementation of the new 2025 edition ,Medical EquipmentSupervision and Administration Regulations, China Customs will enforcefull lifecycle traceability managementon imported medical devices, making compliance operations particularly crucial.

• Complexity of Classification Management
  • Class I device filing system (e.g. surgical instruments)
  • Class II product registration system (e.g. ultrasound equipment)
  • Class III high-risk product clinical approval (e.g. cardiac stents)
• Specificity of Qualification Documents
  • Overseas production enterprises need to obtainMedical Device Registration Certificate
  • Domestic importers must complete filingMedical device business license
• Strictness of Customs Inspection
  • 100% implementation of destination-based inspection
  • Special equipment requiresjoint verification by drug regulatory authorities

Four core capabilities of high - quality agency service providers

When selecting a professional agency company, it is recommended to evaluate from the following dimensions:

• Regulatory Update Tracking Capability
  • Real-time grasp of latest IMDRF (International Medical Device Regulators Forum) requirements
  • Familiarity with filing differences across provincial drug administrations
• Customs Clearance Network Coverage
  • Operational teams in major medical ports like Beijing, Shanghai, and Guangzhou
  • Experience in clearing special goods like biological samples
• Technical document processing capability
  • Capability to complete compliance conversion for CE certificates and FDA certifications
  • Ability to handle technical translations of multilingual instructions
• After-sales Service Support Capability
  • Assistance in establishing UDI (Unique Device Identification) traceability systems
  • Adverse event monitoring report generation

Four Common Operational Errors and Solutions

• Incorrect commodity classification
  • Case: Misclassification of medical linear accelerators (9022.1400) as ordinary electronic equipment
  • Response: Require agents to providePre - classification Service
• Document missing risk
  • Case: Return shipment due to failure to obtain the Medical Device Import Registration Certificate,
  • Response: EstablishThree-level document verification checklist
• Improper logistics configuration
  • Case: Failure to maintain a constant temperature of 2-8°C during transport of in vitro diagnostic reagents
  • Response: SelectDual-temperature zone cold chain transport solution
• Lack of post-sales traceability
  • Case: Failure to upload UDI-DI information to the national database as required
  • Response: Entrust agents to establishMonthly data verification mechanism

Three new industry regulatory trends for 2025

• Electronic registration and filing
  • Full implementation of the electronic Registration and Submission System for Medical Devices (eRPS)
• Precision quality traceability
  • Extension of UDI implementation scope to Class II devices
• Intelligent port inspection
  • Non-invasive inspection for large equipment such as CT machines

Professional medical equipmentImport RepresentationThe value lies not only in completing cargo clearance but also in helping enterprises establish compliance firewalls throughout their lifecycle management. It is recommended that importers require service providers to provideAnnual compliance audit reportandCustomized risk warning solutionsto cope with increasingly stringent regulatory environments.