Ready for Canada: Bentley receives MDSAP certification.

By fulfilling this regulatory requirement, Bentley can now take the first formal steps toward bringing its entire product portfolio to the Canadian market. The MDSAP certification is a prerequisite to start registration activities with Health Canada – and thus essential for any future product approvals in the country. It alsostrengthens Bentley's international competitiveness and enhances regulatory efficiency across key markets. 

MDSAP is one of the key audit programs for medical device manufacturers and allows market approval in several countries, including Canada, the US, Brazil, Australia, and Japan, with just one quality audit. For Bentley, this certification not only opens the door to Canada but also streamlines audit processes globally.  

Until now, Bentley products could only be made available in Canada through the Special Access Program, which requires single application by physicians and individual review by Health Canada. With MDSAP certification, Bentley can now submit regular applications for approval with the aim of rapid registration and full market launch. The goal is to make core products such as BeGraft, BeFlared, BeGraft PLUS, and BeBackavailable in the Canadian market in the near future. 

“This certification is an essential step toward making our technologically advanced solutions available to an even wider range of physicians and patients,” said Christian Bader, CTO of Bentley. "Canada is a strategically important market for us. With MSDAP we now have a clear path to take the next steps in our international growth journey.” 

MDSAP certification also brings clear advantages for markets such as Australia, Brazil, and the US, where Bentley is already active. The harmonized audit process reduces follow-up audits, saves resources, and helps the launch of future product innovations.