Health Canada Makes Changes to Medical Device Establishment Licensing Framework

Health Canada Makes Changes to Medical Device Establishment Licensing Framework

Health Canada has changed its rules and requirements concerning Medical Device Establishment Licensing (MDEL), which provides a regulatory framework for selling or importing medical devices into Canada. Specifically, it serves as the method by which medical device companies selling on the Canadian market demonstrate to Health Canada that their product meets all of the applicable regulatory requirements. This includes procedural documentation, handling of complaints, storage and delivery of devices, and installation and servicing of devices (if applicable). KD&A can develop documentation in conjunction with your organisation to ensure the Health Canada regulatory requirements are complied with.

Health Canada has eliminated the expiration date for its Medical Device Establishment Licenses, choosing instead to opt for a system where licenses can be renewed on a yearly basis as long as the Agency’s Inspectorate receives an Annual Review application prior to April 1 2011. Previously, MDELs expired on December 31 of the calendar year. Companies who currently hold an MDEL will now not be required to apply for renewal until April 1, 2012, and the new annual process completely replaces the previous “application for renewal” system.

More important for medical device companies doing business in Canada for the first time is the establishment of performance standards that are directly tied to the issuance of establishment licenses. Medical device companies will undergo a 120 day evaluation period once their application has been accepted for review. This evaluation does not start from the date of application submission, but the actual date of review acceptance. The evaluation requirement is less than half the 250 days that drug establishment license applicants are subjected to.

Health Canada has yet to describe the performance standards that will be applied to medical device companies in detail, but given that the program came into effect as recently as April 1, 2011, their publication should not be far behind.

KD&A can assist your organisation to complete all regulatory activities needed to gain access to the Canadian medical device market as efficiently as possible. Visit the contact us page to request a quote.