Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements
On May 27, 2021 Health Canada issued a bulletin about cancellation of Medical Device Establishment Licence (MDELs) for the sites that are not compliant with the annual licence review requirements. About 700 MDEL holders have not submitted an annual licence review application for the 2020/2021 fiscal year, and as a result Health Canada cancelled their MDELs. This means that these sites are not able to conduct their activities and must re-apply for a new establishment licence and pay the applicable fees.
Annual Licence Review
An annual licence review (ALR) ensures that medical device establishment licence (MDEL) holders are complying with regulatory requirements associated with the Medical Devices Regulations. An ALR also ensures that their licence information is up-to-date.
As a courtesy, Health Canada sends an ALR application package to all active MDEL holders at the end of each calendar year. Health Canada also sends out 2 reminder notices to the licence contact person on file.
MDEL Holder Responsibilities
To continue doing business, active MDEL holders must submit an ALR application before April 1 of each year as per section 46.1 of the Medical Devices Regulations. Licence holders with a suspended MDEL do not need to apply.
Health Canada will cancel the MDEL for those licence holders who do not submit their ALR application within the required timeline. This authority is set out in section 51.1(b).
Under section 48, active MDEL holders must also notify Health Canada within 15 calendar days if they change their contact information. This includes changing the name or address of their establishment or the information of the establishment representative associated with their MDEL.
Cancellation of MDELs
Since the ALR deadline of April 1, 2021, about 700 MDEL holders have not submitted an ALR application for the 2020/2021 fiscal year. As this violates section 46.1, Health Canada have cancelled their MDELs and removed them from the active MDEL live listing.
MDEL holders whose establishment licence is cancelled are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). They must cease their activities immediately once they receive their cancellation notice.
Resuming Licensable Activities
To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence and pay the applicable fees. In line with the compliance and enforcement policy for health products (POL-0001), Health Canada carries out compliance monitoring activities. Cancelled MDEL holders may be subject to compliance and enforcement actions if Health Canada finds they are conducting non-compliant activities.
For more information on how to re-apply for a MDEL or if you need assistance filling your ALR please visit our website. Our Experts at Quality Smart Solutions continue to support your needs for medical devices, natural health products, foods, cosmetics and OTC drugs for North America. Contact us today to learn more about how we can support your compliance for Medical Device Establishment licence.
References:
Cancellation of MDELs for non-compliance with annual licence review requirements – Health Canada.
