MedicalEquipment Importsspecial requirements

The import of medical equipment involvesa dual regulatory system, which must comply with the import management regulations of the General Administration of Customs and also meet the requirements of the National Medical Products AdministrationMedical EquipmentRegistration requirements. The Medical Device Classification Catalogue newly implemented in 2025 includes 23 types of products such as CT machines and ventilators into Class II supervision, which means that the agency agreement must be clearResponsible party for handling registration certificatesandQuality Guarantee Clause.

Analysis of Core Clauses of the Agency Agreement

• Definition of the Scope of Authorization
  • Clarify agency matters: detailed authorities for customs declaration, transportation, warehousing, and document handling
  • Limit the product scope: name, model of medical devices, and three - digit HS code limitation
• Division of Customs Clearance Responsibilities
  • Obligation of document review: verification responsibility for documents such as medical device registration certificates and test reports
  • Mechanism for sharing demurrage charges: the sharing ratio of port detention fees caused by incomplete documents
• Malaysian importers often file claims on the grounds of “circuit board damage caused by excessive humidity”. Solutions:
  • Installment payment mode: Usually, 30% advance payment + 40% after customs clearance + 30% upon arrival and inspection are adopted.
  • Exchange rate fluctuation clause: clarify that the exchange rate on the date of customs acceptance of the declaration is the settlement benchmark

Practical Key Points for Risk Prevention

The import case of a certain medical device company in 2025 shows that due to the unclear agreementResponsibility for CE certification conversion29., the monitor worth 1.2 million US dollars was detained at the port for 28 days. It is recommended that the agreement must include:

• Clause on the timeliness of qualification documents: monitoring mechanism for the validity period of registration certificates
• Resolution of commodity classification disputes: pre - classification service is included in the scope of agency
• Handling of quality disputes: rules for selecting third - party testing institutions

Suggestions for Additional Clauses of the Agreement

In view of the special storage requirements for medical equipment, it is recommended to addCold chain transportation clause:

• Configuration standard for temperature monitoring equipment
• Temperature anomaly handling plan for transportation delays
• Responsibility for keeping biosecurity certification documents

Strategy for Selecting Agency Services

By comparing the service agreements of 12 agency companies in the Yangtze River Delta region, it is found that the agreements of high - quality agents usually include:

• Pre - classification accuracy guarantee clause (≥98%)
• Warehousing Filing Certificate for Medical Devices
• Written Commitment of the Communication Channel of the Food and Drug Administration

It is recommended that enterprises require the agency company to provide before signing the agreementImport cases of similar products in the past three years, with a focus on verifying its specific plans for handling customs inspections and drug regulatory sampling. A well-drafted agency agreement should serve as a "risk isolation wall" for the import of medical devices, rather than merely a simple service authorization letter.