Documentation

Know what you are buying.

Check the proposed model, written terms and documents for your destination before agreeing supply.

Start with the documents.

Package & support

Published package inclusions, funding scenarios and marketplace fees.

View programme terms

Operating guidance

Request the manual, training scope and maintenance schedule for the proposed model.

Confirm with NUSBE

Market-specific records

Request the relevant declaration, registration or test report, where applicable. Check the issuer, date, model and scope.

Confirm for your country

Who handles what?

NUSBE

Identify the proposed system, share available in-scope documents and confirm supply, training and after-sales terms.

Your local team

Check product classification and intended use with your adviser. Confirm the importer, required approvals, taxes and operating responsibilities.

Model and market matter.

Country status is reviewed privately for the exact proposed model and intended use. This page is a review checklist, not proof of registration or permission to market a device.

Check the official requirements.

Malaysia · medical-device requirements

For products that fall within Malaysia’s medical-device framework, check the device registration and establishment requirements with the Medical Device Authority. A reference to the regulator here does not confirm NUSBE registration.

Medical Device Authority
European Union · importer & distributor duties

Where EU medical-device rules apply, Articles 13 and 14 describe importer and distributor obligations. The applicable route depends on the exact product and intended purpose.

Regulation (EU) 2017/745
Other markets

Ask your local adviser to identify the applicable product classification, import, labelling and operating requirements. Request documents against that checklist before agreeing supply.