To maintain an active Medical Device Establishment Licence (MDEL) must apply to renew their licence before April 1 each year. The purpose of the Annual Licence Review (ALR) process is to ensure that MDEL holders continue to comply with the Canadian Medical Device Regulations, and to ensure licence information is current with Health Canada.
The agency strongly encourages MDEL holder to submit their application early! Here’s what you need to know:
ALR applications for MDEL renewal is sent to all active MDEL holders in December of every year. There is a new fillable ALR summary report available in this package. Try to complete the ALR as early as possible, especially if you have many sites listed on your application (i.e., greater than 20) or are making an amendment. Currently, Health Canada is not accepting ALRs by mail – you must email your ALR to firstname.lastname@example.org.
Fees are required for the Agency to process your ALR package. Once Health Canada reviews the ALR for completeness, an invoice will be issued. The current fee is $4,581 CAD. Remember, if you are a small business and registered with Health Canada as such, you’re eligible to receive a 25% reduction in fees! Per Health Canada, a small business is defined as any business (incl. its affiliates) that has fewer than 100 employees OR has between $30,000 and $5 million (CAD) annual gross revenues. You must be registered as a small business prior to submitting your ALR for a fee reduction to be granted.
Without payment, the MDEL will be cancelled.
Health Canada’s service standard is 120 calendars to review and process a complete and paid application. Any deficiencies identified during screening and review, will be communicated with a timeline to response. In the even an MDEL holder fails to meet this deadline, the MDEL will be cancelled, and you will need to apply for a new licence.
For regulatory or quality support with for medical devices, contact AXSource today at email@example.com.