Exporting and importing medical equipment internationally sits at the intersection of three regulatory regimes: origin-country medical device regulation, destination-country medical device regulation, and the customs regimes at both ends. Errors at any of the three cause delay.
Origin documentation: Certificate of Free Sale (CFS) from the origin regulator confirming the device is legally sold in the origin market; Declaration of Conformity; ISO 13485 certificate; commercial invoice; packing list; certificate of origin; bill of lading or air waybill.
Destination requirements: most destination markets require pre-market device registration with the local medical device authority (SFDA, MOHAP, NAFDAC, PPB, CDSCO, etc). Either the importer handles registration or the supplier handles it via partner channels — confirm before shipment.
Customs: HS code classification accuracy matters — the wrong HS code means the wrong duty rate and increases the likelihood of customs hold. Pre-brief the destination customs broker with the documentation pack before cargo arrives.
Dangerous goods: IVD reagents containing certain chemicals are classified as dangerous goods under IATA / IMDG and require DG-certified packing and shipping.