Equipment & packing
M1, M2 and M3 sizes, weights and freight-planning notes.
Documentation
Check the proposed model, written terms and documents for your destination before agreeing supply.
M1, M2 and M3 sizes, weights and freight-planning notes.
Published package inclusions, funding scenarios and marketplace fees.
Request the manual, training scope and maintenance schedule for the proposed model.
Request the relevant declaration, registration or test report, where applicable. Check the issuer, date, model and scope.
Identify the proposed system, share available in-scope documents and confirm supply, training and after-sales terms.
Check product classification and intended use with your adviser. Confirm the importer, required approvals, taxes and operating responsibilities.
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.
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 AuthorityWhere 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) 2017/745Ask your local adviser to identify the applicable product classification, import, labelling and operating requirements. Request documents against that checklist before agreeing supply.