I. Medical EquipmentImport RepresentationFour Major Qualification Thresholds

According to the Regulations on Supervision and Administration newly implemented in 2025,Medical EquipmentAccording to the Supervision and Administration Regulations, professional agency service providers must possess the following core qualifications:

• Medical device business license(Must include import agency business scope)
• import and exportIntellectual Property Recordation Certificate(AEO-certified enterprises by customs have more advantages)
• Product registration/filing certificates(Class II and III medical devices require NMPA approval)
• Quality system certifications(ISO13485 medical device-specific certification)

II. Key Qualification Documents for Customs Inspection

In 2025, the General Administration of Customs will implement a dual-random + intelligent document review mechanism in medicalEquipment ImportsThe process implements a "dual-random + intelligent document review" mechanism, with special attention to:

• Accuracy of product classification codes (whether involving3Ccertification catalog)
• Compliance of Chinese labels (must include 15 elements such as production date and expiration date)
• Registration information of overseas manufacturers (must match the whitelist of the General Administration of Customs)
• Validity of test reports (must be issued by CNAS-accredited laboratories)

III. Five Major Risks of Incomplete Qualification Agency Service Providers

• Clearance delay risk:: In 2025, the average customs clearance time for medical devices will extend to 7 working days
• Quality traceability risks: New regulations require establishing a full lifecycle traceability system
• Administrative penalty risks: Operating without a license may result in fines up to 30 times the goods value
• Supply Chain Disruption Risk: Failure to rectify within the deadline will be included in customs key monitoring list
• After-sales rights protection risks: Equipment imported through illegal channels does not qualify for three-guarantee services

Guide for Identifying High-quality Agency Service Providers

It is recommended to screen compliant agents through the "three checks and three reviews":

• Check the filing system: Verify business license numbers on the official website of the Medical Products Administration
• Review customs clearance records: Request import certificates for similar equipment from the past three years
• Check service network: Confirm capability for both domestic and international customs clearance
• Review risk control system: Request documents showing product compliance pre-review processes
• Check insurance coverage: Professional liability insurance coverage should be no less than 5 million yuan

New Changes in Qualification Management for 2025

• Newly addedAI medical devicesSpecial filing requirements
• implementationElectronic certificate interoperability(Mutual recognition with EU MDR and US FDA)
• EnableUnique Device Identification (UDI)(UDI) Tracking System
• StrengthenCold Chain Logistics QualificationVerification (Newly Added -25°C Ultra-Low Temperature Transport Certification)

In the field of medical device import agency, qualification compliance is not only the entry threshold for business operations but also a moat for sustainable operations. Choosing service providers with a complete qualification matrix can not only ensure customs clearance efficiency but also help enterprises avoid over 95% of compliance risks. It is recommended that enterprises establish a dynamic verification mechanism for supplier qualifications and regularly update verification documents to adapt to rapidly changing regulatory requirements.