FDA & Health Canada Medical Devices & IVDs Compliance Services
Obelis supports medical device manufacturers & brand owners comply with U.S FDA and Health Canada requirements through expert regulatory consultancy, in-country representation and submission support.Â
Obelis Support Your Brand Across North America
Obelis Group
Boulevard Brand Whitlock 30,Â
Brussels, 1200, Belgium
Tel: +32 (0)2 732 59 54
hello@obelis.net
© Obelis Group 2026
Frequently Asked Questions
Do I need a US Agent to place my medical devices on the U.S. market?
Yes. All foreign medical device manufacturers must appoint a US Agent recognized by the FDA to legally market their device in the United States. The US Agent is responsible for facilitating communication with the FDA, supporitng Establishment Registration and Device Listing and assisting during inspections or regulatory follow-ups. Having a professional US Agent like Obelis Group helps ensure faster responses, fewer delays in the registration process and full compliance with FDA expectations.Â
What are the key regulatory steps to register a medical device with the FDA in the United States?
Medical devices marketed in the U.S. must comply with several FDA requirements including establishment registration (to be renewed annually), FDA device listing for each marketed device, label review & UDI compliance to meet U.S. labelling rules, and medical device reporting (MDR) for post-market surveillance. Depending on the device classification, additional processes such as 510(k), De Novo, or PMA may apply. Working with a regulatory partner like Obelis Group ensures that all obligations are met smoothly and on time.Â
What licenses are required to sell medical devices in Canada?
To place medical devices on the Canadian market manufacturers must comply with Health Canada regulations. This typically includes, MDEL (Medical Device Establishment License) for companies imporitng or distributing devices, MDL (Medical Device License) for Class II - IV devices, Health Canada Regulatory Correspondent for foreign manufacturers and MDSAP compliance for quality system requirements. The licenses must be kept up to date to maintain lawful distribution in Canada.Â
What is the difference between U.S. FDA and Health Canada requirements for medical device compliance?
While both markets regulate medical devices strictly, their framework differ. In the U.S. the FDA required foreign manufacturers to appoint a US Agent, complete annual Establishment Registration, maintain Device Listing and comply with UDI, labelling and MDR rules, with market authorization pathways depending on device class. In Canada, Health Canada requires a Regulatory Correspondent, MDEL/MDL licensing based on device class, and MDSAP audits for certain devices. These differences make it essential to tailor compliance strategies for each market.Â
U.S FDA Regulatory Support
Health Canada MD Support
- US Agent & Official Correspondent
- US Establishment Registration
- FDA Device Listing
- Label Review & UDI Support
- Medical Device Reporting (MDR)
- Regulatory Consultancy
- Health Canada Regulatory Correspondent
- Medical Device Establishment License (MDEL) Submission
- Medical Device License (MDL) Submission
- MDSAP Gap Assessment
Make sure your product comply with two of the world's most demanding regulatory frameworks and avoid non-compliance penalties
Enter new markets with confidence
Why Our Clients Choose Us
Since 1988: Decades of proven expertise in the cosmetic regulatory industry across global markets.
Client-centric approach: Tailored regulatory strategies designed around your business needs and timelines.
Proven track record: Thousands of successful cosmetic product launches delivered compliantly to market.
Fast processes: Efficient execution without compromising regulatory accuracy with high-quality guidance.
Cross-border regulatory specialists: Seamless coordination between U.S and Canadian compliance requirements.
In-country representation: Our local offices in the USA and Canada provide you with a trusted local presence to act on your behalf and communicate with authorities.
Ready to take your medical device brand across North America without regulatory delays?
I encourage companies to seek compliance before putting their products on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.​
 We successfully launched our products into multiple European countries.
Ran Amos
VP of Quality Assurance & Regulatory Affairs
We were under huge time and cost pressure for a new OEM product line launch and we relied on Obelis. It was the right decision, their expert team helped us to avoid possible regulatory complications.
Their expert team helped us to avoid possible regulatory complications
Florian L. GablenzÂ
Business Development ManagerÂ
We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make it seem so easy.
 We feel very supported!
Javier Aravena
Regulatory Affairs Manager
Client Success Stories
FDA & Health Canada Medical Devices & IVDs Compliance Services
Obelis supports medical device manufacturers & brand owners comply with U.S FDA and Health Canada requirements through expert regulatory consultancy, in-country representation and submission support.Â
Obelis Support Your Brand Across North America
U.S FDA Regulatory Support
Health Canada MD Support
- US Agent & Official Correspondent
- US Establishment Registration
- FDA Device Listing
- Label Review & UDI Support
- Medical Device Reporting (MDR)
- Regulatory Consultancy
- Health Canada Regulatory Correspondent
- Medical Device Establishment License (MDEL) Submission
- Medical Device License (MDL) Submission
- MDSAP Gap Assessment