Breaking the Deadlock under the New Landscape of Global Ophthalmic Equipment Trade

According to the latest WHO statistics, the global ophthalmic medical device market is projected to exceed USD 42 billion in 2025, with China’s export share rising to 28 percent. Amid increasingly stringent international regulatory environments, exporters must accurately master the following six core elements:

1.Medical DevicesDynamic classification management mechanism

After the 2025 edition of the new IMDRF classification standard takes effect, ophthalmic devices should pay special attention to:

• The laser therapy device has been upgraded from Class Ⅱa to Class Ⅱb.
• Risk-assessment requirements for the newly added software algorithm of the corneal topographer
• The intraocular lens implantation system complies with the latest biocompatibility standard ISO 11979-7.

II. Practical Responses to EU MDR Certification

In response to the full implementation of the MDR regulation in 2025, a three-step strategy is recommended:

• Technical Documentation Refactoring
  • The clinical evaluation report must include 5-year follow-up data.
  • UDI Coding System Integration with the EUDAMED Database
• Selection of Notified Body
  • Priority should be given to institutions with specialized ophthalmic review qualifications.

III. Key Breakthrough Points for U.S. Market Access

Against the backdrop of a 12% increase in FDA’s FY 2025 medical-device registration fees, we recommend:

• 510(k) pre-submission document preparation cycle shortened to 90 days
• QSR quality system audit focus shifts to the supplier management module
• Ophthalmic laser equipment must additionally submit ANSI Z136.3 compliance certification.

IV. Design of Special Logistics Solutions

For precision equipment containing laser modules, a composite transportation solution is recommended:

• Air freight: The UN3481 dangerous-goods label must use the new version.
• Maritime transport: The constant-temperature container must be equipped with a dual-circuit control system.
• Multimodal transport: German/Dutch ports prioritize medical-only lanes

V. Triple Verification of Customs Declaration Document Management

To avoid customs clearance delays, the following must be established:

• Basic Document Verification System
  • Origin CertificateCross-check against the HS code
• Technical Document Synchronization Mechanism
  • CE Certificate and DoC Declaration Version Consistency Check

VI. Compliance Closed Loop for Post-Sales Follow-Up

In accordance with MDR Article 83, the following shall be established:

• Equipment Traceability System (covering production batches to end users)
• 72-Hour Rapid Response Mechanism for Adverse Events
• The notification system for software upgrades in EU member states

Practical suggestions: Export companies are advised to set up a dedicated export archive for medical devices, digitally linking technical documentation, test reports, and certification certificates, and to periodically review the latest regulatory updates from the Competent Authorities (CAs) of individual EU Member States. Firms whose annual exports exceed USD 5 million should consider establishing a permanent overseas office for their European Authorized Representative (EC REP).