Medical EquipmentConstruction of the legal firewall for import authorization

Under the framework of the new regulations for importing medical devices in 2025, the agency authorization letter has evolved from a simple power - of - attorney toa legally compliant document. According to the latest statistical data of the General Administration of Customs of China, 34.7% of the abnormal import declarations of medical devices are due to flaws in the authorization documents.foreign tradeAgency companies need to pay special attention to theverification of the legal eligibility of the authorizing subject, including but not limited to:

• Proof of the legal existence of the overseas manufacturer in its place of registration
• Verification of the validity period of the Medical Device Manufacturing License
  • Logical relationship between the issuance time of FDA registration documents and the power of attorney
  • Degree of matching between the scope of CE certification and the authorized product categories

New essential elements of the power of attorney terms in 2025

Compared with the 2023 version of the authorization template, the 2025 regulatory document has added three mandatory clauses:

• Traceability liability clause: Clarify the product life - cycle traceability mechanism
• Emergency recall clause: Agree on a 48 - hour emergency response mechanism
• Data security clause: Cover data transmission specifications for intelligent medical devices

A certain European pacemaker manufacturer, due to omissionTraceability liability clause, resulting in goods worth $12 million in 2025年3月 being detained at Shanghai Port, with a direct loss of up to $830,000.

Resolution of the contradiction between regional authorization and cross - border execution

Medical device power of attorney often facesJurisdiction conflictissues. It is recommended to adoptDual - certification mode:

• Notarization and certification of the place of origin
• Certification by Chinese embassies and consulates abroad

The case of a certain American CT machine manufacturer shows that the customs clearance efficiency of the power of attorney documents with dual - certification has increased by 40%, and the incidence of legal disputes has decreased by 67%.

Three golden standards for the selection of foreign trade agents

Professional medical equipmentImport RepresentationShould have:

• Dual qualifications for medical device filing
  • Imported medical device registration certificate
  • Medical device business license
• Customs AEO Advanced Certification
• Overseas legal counsel network

Five early warning signs of the invalidation of the power of attorney

When the following situations occur, the authorization update procedure should be immediately initiated:

• The remaining validity period of the product registration certificate is less than 6 months.
• The equity structure of the manufacturer has changed.
• The applicable scope of the product has been expanded.
• Special regulatory areas have been added to the target market.
• The Classification Catalogue of Medical Devices in China has been adjusted.

With the promulgation of the detailed rules for the implementation of the Regulations on the Supervision and Administration of Medical Devices in 2025, it is recommended that enterprises conducta compliance review of authorization documents. Professional foreign trade agency companies should establisha three - dimensional risk prevention and control system: pre - event legal review, in - process flow monitoring, and post - event document filing to ensure the legal and compliant operation of the entire chain of medical device imports.