GHMAP

Medical device registration pathways by country

Structured market-access overviews for primary and major markets — local representative rules, planning timelines, and submission steps. Planning intelligence only — not a regulatory determination or clinical decision support.

Request a pathway brief

Timeline and fee figures on pathway pages are illustrative until primary sources are verified. Professional review is required before business use.

Active pathway pages

Focus regions include Türkiye, Middle East, Africa, Europe, the UK, the United States, and Canada.

Canada

Health Canada

Class I medical device registrationSource tracked
Class II medical device registrationSource tracked
Class III medical device registrationSource tracked

European Union

EU MDR

Class I medical device registrationSource tracked
Class IIa medical device registrationSource tracked
Class IIb medical device registrationSource tracked
Class III medical device registrationSource tracked

Nigeria

NAFDAC

Class IIa medical device registrationSource tracked
Class IIb medical device registrationSource tracked
Class III medical device registrationSource tracked

Saudi Arabia

SFDA

Class IIa medical device registrationSource tracked
Class IIb medical device registrationSource tracked
Class III medical device registrationSource tracked

South Africa

SAHPRA

Class IIa medical device registrationSource tracked
Class IIb medical device registrationSource tracked
Class III medical device registrationSource tracked

Türkiye

TİTCK

Class I medical device registrationSource tracked
Class IIa medical device registrationSource tracked
Class IIb medical device registrationSource tracked
Class III medical device registrationSource tracked

United Arab Emirates

MOHAP

Class IIa medical device registrationSource tracked
Class IIb medical device registrationSource tracked
Class III medical device registrationSource tracked

United Kingdom

MHRA

Class IIa medical device registrationSource tracked
Class IIb medical device registrationSource tracked
Class III medical device registrationSource tracked

United States

FDA

Class I medical device registrationSource tracked
Class II medical device registrationSource tracked
Class III medical device registrationSource tracked