Medical EquipmentImport RepresentationThe Legal Status and Value of Individuals

According to the "Medical EquipmentThe revised version of the "Supervision and Administration Regulations" clearly defines the agent for imported medical devices as the legal entity responsible for overseas manufacturers within China. This role entails 13 statutory obligations, including product registration and filing, quality monitoring, and post-market traceability. Its professional competence directly impacts the efficiency of device access and compliance safety.

The Four Major Qualification Thresholds for Competent Agents

• Legal entity qualification: A medical device business license is required, and the registered capital shall not be less than RMB 5 million.
• Filing Certificate: Electronic filing has been completed in the Medical Device Agent Filing System of the National Medical Products Administration.
• Quality system: Establish a full-process traceability system compliant with ISO 13485 standards
• Professional personnel allocation: At least 3 technical personnel holding the qualification of Medical Device Registration Specialist shall be allocated.

Analysis of key control points in the entire import process

Pre - preparation Stage

• Product Access Evaluation: Confirm the equipment management category by referring to the "Medical Device Classification Catalog."
• Technical document translation: The original manual must be accompanied by a notarized Chinese translation.

Mid-term implementation phase

• Registration and Filing: The average processing time for Class II devices will be reduced to 90 working days (2025 New Regulation).
• Logistics Customs Clearance: Special Packaging Requirements and Cold Chain Transportation Monitoring Standards

Post-service phase

• Technical Verification: Performance Test Report issued by a provincial-level testing agency
• After-sales traceability: Establish an adverse reaction monitoring and recall emergency mechanism.

Typical Risk Case Warning

Success Case:A German CT device completed its Class III medical device registration through a professional agent within 135 days, reducing the process by 40 working days compared to the industry average. The key factors were completing clinical trial filing in advance and adopting a pre-review mechanism.

Failure Case:A U.S. ventilator was detained at the port for eight months due to incomplete agent qualifications, resulting in equipment worth 20 million yuan being stranded. The main issues included failure to promptly update product standard change information and missing critical parameters in the translation of technical documents.

The golden standard for selecting an agent

• Check the registration success rate of similar products in the past three years.
• Evaluate the coverage capability of the regional service network
• Verify the emergency response mechanism for unexpected incidents.
• Compare the reasonableness of service fee structures

Professional agents provide not only customs clearance services but also a risk management system. It is recommended that enterprises pay special attention to the timeliness clauses in the quality agreement regarding technical document updates, responses to standard changes, and adverse event reporting when signing contracts, to avoid compliance risks caused by information delays.