1. The additional regime
Medical devices face the most documentation-intensive regulatory regime of any product category.
2. The ordinary set
Commercial invoice.
Packing list.
Bill of lading.
Certificate of origin.
3. The destination registration
European Union
Medical devices require CE marking under the Medical Device Regulation or the In Vitro Diagnostic Regulation.
The manufacturer holds the technical file and, for higher-risk classes, a notified body certificate.
The device’s registration in EUDAMED, and the authorised representative in the EU.
United States
FDA clearance or approval: 510(k) premarket notification, De Novo, or premarket approval, depending on the device class.
Establishment registration and device listing.
The agent in the US.
China’s exports to other markets
Each destination has its own registration, and most require the manufacturer’s home-country approval as a prerequisite.
4. The free sale certificate
Required by most destination registries, confirming that the device is approved and freely sold in China.
This is the document that connects the Chinese approval to the destination registration.
5. The ISO 13485 certification
The quality management system standard for medical devices.
Required by most destination registries, and verified with the certification body.
6. The technical file
The design and manufacturing documentation, including:
Device description and specification.
Risk analysis.
Verification and validation.
Clinical evaluation.
Labelling and instructions for use.
The file is held by the manufacturer and made available to the regulator on request.
7. The clinical evidence
Where the device requires clinical evaluation, the documentation supporting it.
For higher-risk devices, clinical investigation data.
8. The post-market obligations
Adverse event reporting.
Field safety corrective actions.
Post-market clinical follow-up.
These are ongoing obligations, not shipment documents, and they determine whether the registration stays valid.
9. The spare parts and accessories question
Accessories may be classified as devices in their own right, requiring separate registration, or as components of the parent device.
The determination affects the documentation for each shipment.
10. Common errors
No destination registration
The device cannot be imported.
Free sale certificate not matching the device
The scope has to cover the specific device and model.
ISO 13485 certification expired
Verified with the body.
Technical file not available
The regulator’s request cannot be answered.
Accessory classified wrong
Separate registration missed.
11. Closing view
Medical devices are a category where the documentation is inseparable from the product’s regulatory approval, and the trade documents are a small fraction of the file.
Exporters should treat the destination registration as a precondition of the export rather than as a parallel process.
*This article is based on EU MDR and IVDR, US FDA requirements and destination medical device registration regimes. Exporters should confirm requirements with the destination regulator.*