Pharmaceutical Equipment?Export Agency?The Specificity of the Agreement

In the context of stricter global medical device regulations in 2025, the pharmaceutical?Equipment Export?industry faces three new challenges:the transition period for the implementation of new FDA regulations,the expanded requirements for EU MDR certification, and localization production policies in emerging markets. As the first line of defense in risk control, the agency agreement requires special attention to the design of three types of special clauses.

Analysis of Core Clauses in the Agreement Structure

A typical agency agreement should include the following modules:

• Scope of Work Definition
  • Whether it includes the preparation of CE/FDA certification documents
  • Division of authority for secondary modification in the target market
• Fee structure design
• Mechanism for sharing special customs handling fees
• Cost-sharing ratio for technical document translation

2025 Risk Warning List

• : Legal risk refers to the risk that the agent suffers losses due to legal issues such as contract disputes and intellectual property disputes. The agent should strengthen the study of laws and regulations, abide by laws and regulations, and avoid legal risks.
  • Traceability liability clause of Article 83 of the EU MDR
  • Joint liability for importer qualifications in Southeast Asian countries
• Technical Barriers
  • Radiation safety certification documents for sterilization equipment
  • Compliance of the temperature recording module of the freeze-dryer

Agreement Optimization Strategies

It is recommended to add three additional clauses to the standard agreement:

• Technical acceptance clauses

  Clearly define the 72-hour continuous operation test standard after equipment installation and commissioning, and specify the re-inspection procedure by a third-party testing agency.

• Special provisions for intellectual property

  For patented modules of filling lines, set up technical dismantling restriction clauses and an infringement compensation calculation model.

Evaluation Dimensions for the Agency Company

When selecting a partner, the key areas to evaluate include:

• A case library of clearing similar equipment in the target market
• Whether it has a dedicated logistics channel for medical equipment
• Emergency response mechanism for FDA on-site inspections

Key Nodes in the Service Process

• Pre-inspection stage: Perform ASTM F1980 accelerated aging tests
• Transportation stage: File real-time monitoring data from temperature-controlled equipment
• Post-customs clearance: Retain a quality traceability document package for 12 months

Insights from a Practical Case

In a case of exporting a freeze-dryer to Germany, the equipment worth $400,000 was detained at the Port of Hamburg because the agreement did not specify the responsibility for MDR certification conversion. The final solution was:

• Activating an emergency certification service channel
• Adopting a temporary solution of leasing local factory space
• Sharing 80% of the additional costs through a supplementary agreement