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RAPS and CAPRA Collaborate on Authoritative Book on Canada’s Medical Device Regulations

Posted 25 July 2018 | By Zachary Brousseau 

RAPS and CAPRA Collaborate on Authoritative Book on Canada’s Medical Device Regulations

While Canada’s medical device market may be small compared with that of the US or EU, it ranks among the top 10 in the world. The Canadian government estimates the country’s device market to be worth $6.7 billion (US) and about 2% of the global market. The US Department of Commerce’s International Trade Administration values it even higher at an estimated $8 billion, making it the world’s ninth largest.

A new book, Fundamentals of Canadian Medical Device Regulations, published by RAPS, in partnership with the Canadian Association of Professionals in Regulatory Affairs (CAPRA), can serve as a key resource for device companies seeking entry into the Canadian market.

As has been pointed out by Don Boyer, RAC, FRAPS, a former longtime Health Canada senior official, who is currently RAPS president and also an author and key contributor to the book, lack of knowledge and understanding of Canada’s regulatory framework for medical devices is quite common. This book can help bridge that knowledge gap for regulatory and medical technology industry professionals at all levels.

Fundamentals of Canadian Medical Device Regulations provides a one-of-a-kind reference on Canada’s regulations governing medical devices and IVDs. The book features a compilation of information that cannot be found anywhere else. It also will serve as a useful study tool for those preparing for the Canadian Regulatory Affairs Certification (RAC) exam. Chapters are authored by former Health Canada officials and other leading experts on Canadian regulatory affairs.

Publication of the book marks the latest in a series of collaborations between RAPS and CAPRA, including a second book to come on Canada’s pharmaceutical and biologics regulations and educational sessions planned for the 2018 RAPS Regulatory Convergence, which will be held in Vancouver this October, featuring updates directly from Health Canada Officials on the agency’s latest plans and initiatives.

Providing the best regulatory information and strengthening ties with CAPRA and the regulatory community in Canada are important undertakings for RAPS, said Executive Director Paul Brooks. “CAPRA has been instrumental in helping inform the global regulatory community about Canada’s regulations governing healthcare products,” he said.

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