The licensed importer sits between you and the manufacturer
Hospitals rarely import directly. An authorised distributor holding a DRAP establishment licence handles import, clearance and regulatory documentation, and carries responsibility for post-market obligations.
This matters commercially: the distributor's licence, service capability and spare-parts depth are part of what you are buying, not incidental to it.
Documentation is the long pole
A typical import file includes the establishment licence, device registration or enlistment, manufacturer's authorisation letter, certificate of origin, free-sale or equivalent certificate, invoice and packing list, and shipping documents.
Incomplete documentation at the port is expensive. Demurrage accrues daily on equipment sitting in a container.
Site readiness runs in parallel, not after
The most common cause of delayed commissioning is not shipping — it is the site. Power supply and stabilisation, flooring load, door and corridor clearances, air conditioning and heat load, water supply and drainage, radiation shielding where applicable, and network provision all take time.
A competent supplier issues site-preparation requirements early and conducts a pre-delivery site survey. Ask for both at quotation stage.
Installation, commissioning and acceptance
Delivery is not commissioning. Define in the purchase order what constitutes acceptance: installation complete, calibration verified, acceptance tests passed, operator training delivered, documentation handed over, warranty start date agreed.
Tie final payment to acceptance rather than to delivery. This single clause prevents most post-installation disputes.
Plan the service relationship before purchase
Ask who performs service, where engineers are based, response and resolution commitments, what spares are held locally, consumable and part costs over five years, and training provision for your biomedical staff.
For imaging and radiotherapy especially, service economics over the installed life frequently exceed the purchase price.
Frequently asked questions
Can a hospital import equipment directly?
Import of medical devices requires appropriate licensing under the Medical Device Rules, 2017. Most hospitals purchase through a licensed importer or distributor.
What delays installation most often?
Site readiness — power, civil works, environmental conditions and network provision — rather than shipping.