Guide

Class II, III or IV medical device: obtain the product licence before import or sale

Confirm class and manufacturer, assemble quality-system and required evidence, pay fees and track information requests.

Priority

An importer or distributor MDEL does not license the product. Every Class II to IV device must be licensed or expressly exempted.

Confirm the scope

Determine whether the product is a device, its class, identifiers, manufacturer and applicable family grouping.

Choose a new, private-label or amendment application and confirm the required quality-system certificate.

Gather labels, intended use, safety and effectiveness evidence, standards and class-specific attestations.

File with fees, answer deficiencies and do not import or sell before the licence is active.

Official sources are linked in the guide. Checked August 29, 2026; confirm current rules, forms and deadlines with the responsible authority.

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