How to import medical devices from China?

Medical-device imports are regulated by the destination market, not simply by the country of manufacture. Importers should begin by defining the device’s intended use, product code, risk classification, and regulatory pathway. They should then confirm that the Chinese manufacturing site operates under an appropriate quality system and can provide the required technical, clinical, and batch documentation.

A typical import process includes:
• Classify the device in the destination country.
• Determine whether product registration, notification, clearance, or approval is required.
• Verify the legal manufacturer, manufacturing site, ISO 13485 status, and regulatory history.
• Appoint the required local representative, authorized representative, or importer.
• Review labeling, instructions, language, UDI, packaging, and shelf-life requirements.
• Prepare invoices, packing lists, certificates, product codes, and customs declarations.
• Establish complaint handling, traceability, vigilance, and recall procedures.

For the United States, FDA may verify establishment registration, device listing, labeling, and any required 510(k) clearance or premarket approval at importation. Foreign manufacturers must designate a U.S. agent, while the initial importer must maintain a staffed U.S. address and register with FDA. Incorrect manufacturer, listing, or premarket-submission information can cause detention or refusal.

Importers should also check FDA import alerts and conduct supplier audits or documented qualification before placing commercial orders.