Nov 22, 2013
Canadian medical device market regulators have begun making some information on medical device clinical trials available upon request in an effort to boost public access to such data.
Health Canada’s new policy entails sharing information including:
Regulators will not, however, provide testing information pertaining to healthy volunteers. Manufacturers and importers will handle questions regarding patient enrollment criteria, testing sites and investigation status.
Expect to see more medical device market regulators pursue similar initiatives for more transparent clinical trial information going forward.
Medical device market regulators in Canada have added 11 new items to their list of recognized standards, removed six and amended another 27.
Standards newly recognized by Health Canada include IEC and ISO standards covering various electrical medical device components, implantable devices and IVDs.
The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities.
Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market in these regions.