Medical → Canada

Expert Regulatory Support for Entering the Canadian Medical Device Market

Canada is one of the world’s most reputable and well-regulated medical device markets, overseen by Health Canada. To legally commercialize medical devices in Canada, manufacturers must comply with a full set of national regulatory requirements, including device licensing (MDL), establishment licensing (MDEL), quality system obligations, labelling rules, and bilingual compliance. With more than 30 years of regulatory experience, Obelis supports manufacturers at every step of their Canadian market entry strategy.

Get in touch

Discover our Services

Get in touch

Health Canada Regulatory Correspondent

MDEL Submission

MDL Submission

Other Regions

Our international standing means we offer compliance services around the globe. This makes us an ideal choice for manufacturers who market their products in several global markets.

United States

The United States is one of the largest and most competitive cosmetics markets, requiring compliance with new MoCRA’s FDA rules.

United Kingdom

The UK maintains its high position in the global cosmetics industry with a dynamic market, requiring compliance with its own Cosmetics Regulation, including appointing a UK Responsible Person and submitting product data via the SCPN portal.

European Union

The EU cosmetics market, serving over 450 million consumers, offers vast opportunities for growth but demands strict compliance with Regulation (EC) No 1223/2009 for market access.

COSlaw.eu is the internet's most extensive information platform on cosmetics law.

Explore

Industry News

View all

Start your compliance journey with Obelis.

Get in touch