As much of the focus surrounding medical device regulation involves FDA and EU requirements, the regulations in Canada can be misunderstood. Although the degree of difficulty in regulatory approval varies between Canada, the United States, and Europe, manufacturers may want to consider licensing in Canada during the initial phase of launching a new product, says Rob Packard, founder of Medical Device Academy, Inc.
|CMDCAS Certification and the Canadian MDR
Date: Wednesday, April 8, 2015
Time: 1-2 pm ET
“Most manufacturers assume that the regulatory pathway is similar in all three countries, and many companies do not pursue approval in Canada or Europe because they are not familiar with the process,” says Packard. “In reality, [the pathway is different]. One product I’m working on is considered a low- to medium-risk device in Canada and Europe, while the U.S. requires a PMA submission for the same product.”
Not sure how to approach the medical device market in Canada? Packard will be discussing why companies should consider Canada as a critical player in launching new products during the “CMDCAS Certification and the Canadian MDR” webinar on Wednesday, April 8 at 1 pm ET.
Key topics include the progress of the Medical Device Single Audit Program (MDSAP), how using the Summary Technical Document (STED) format for preparing regulatory submissions will assist manufacturers with Canadian submissions and the new European Medical Device Regulations, and the differences between the Canadian Medical Devices Conformity Assessment System (CMDCAS) and ISO 13485 certification.
A look ahead: According to Packard, Health Canada plans to adopt the MDSAP program in place of the current CMDCAS program in 2017, which could have a significant impact on adoption rates for the MDSAP program.