Medical Licensing is Essential – Also In Canada
The Canadian market offers enormous potential for medical technology manufacturers, but it is highly regulated. Anyone wishing to export or distribute products in Canada must have a so-called Medical Device Establishment Licence (MDEL). This licence is a legal requirement for companies outside Canada that wish to supply medical products to Canadian distributors or end customers.
The MDEL serves to ensure the quality and traceability of products in the national healthcare system and is therefore a central component of Canadian market surveillance. However, approval is a complex process, as it involves extensive documentation requirements – quality assurance, product safety, internal responsibility structure, to name but a few.
How To Obtain An MDEL
Put simply, the MDEL is the Canadian equivalent of the European SRN.
To apply for an MDEL, companies must, among other things:
- demonstrate a functioning quality assurance system,
- submit complete technical documentation,
- designate a responsible person to act as a contact for Health Canada.
It is advisable to seek the assistance of experienced consultants at an early stage. BEO BERLIN provides structured support throughout the entire approval process and assists with the formal and substantive implementation of the requirements.
The ALR – Annual Updates? Really?!
The Annual Licence Review (ALR) is a mandatory component of the MDEL. Companies must renew their licence annually – both in terms of content (e.g. updated information) and financially (by paying a fee). The aim is to ensure that all market participants are always up to date with the latest regulatory, technical and economic developments.
Please note: Health Canada adjusts its fees regularly. Increases have already been announced for 2025/2026 – partly in response to inflation and overall economic trends.
Anyone who misses the ALR deadline risks automatic deletion of the MDEL and thus loses market access. The annual reminder and deadline check should therefore be firmly integrated into regulatory processes.
Challenges And Chances For Small And Medium-Sized Buisnesses
For small and medium-sized businesses (SMBs), the annual renewal can become a financial burden. The fees are initially charged regardless of turnover or company size – and increase continuously.
At the same time, however, Health Canada is providing targeted relief for SMBs. The Small Business Fee Mitigation programme allows eligible companies to significantly reduce or even completely avoid regular fees. The prerequisite: Formal recognition as a small business must have been applied for and confirmed – ideally before submitting other documents; we reported.
BEO BERLIN not only supports you in the application process, but also in the strategic planning of your market activities in Canada – including deadline monitoring, fee optimisation and communication with Health Canada.
What Qualifies As SMB In Canada?
The definition of small and medium-sized buisnesses (SMB) in Canada is based on clear criteria:
- Less then 100 employees worldwide and and
- annual global turnover of less than 30 million Canadian dollars.
This definition applies regardless of the company's legal form or headquarters. Important: The application for recognition as an SMB must vor der Einreichung der MDEL-Unterlagen erfolgen, damit er für alle Gebühren und Verwaltungsakte berücksichtigt wird.
Contact Us – For A Standing In The Canadian Market!
Would you like to future-proof your market strategy for Canada?
Are you planning to join MDEL, require assistance with ALR, or would like to take advantage of SMB benefits?
BEO BERLIN is here to help you – with expertise, reliability and on time.
From the initial document review to the final submission, we take care of regulatory compliance for you.
Contact us – so that you are prepared.
Or reach us directly via our contact form. We help you strengthen your position in the Canadian medical device market.
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