##  [Medical Device Registration in The Americas](/index%2ephp/medical-devices/medical-device-registration-in-the-americas) 

# Medical Device Registration in the America Region

Bringing a medical device to market in North America means navigating distinct but connected frameworks for registration in the US and Canada. Covering the full spectrum of regulatory requirements, from US FDA medical device registration, FDA device establishment registration, and listing in the United States, to Health Canada Medical Device Licenses (MDL) and Medical Device Establishment Licenses (MDEL), every step needs careful planning. Freyr supports manufacturers, importers and start-ups with an integrated US and Canada market access approach, helping you interpret requirements, define the right regulatory strategy and move efficiently from development to approval and ongoing compliance.





### Speak to our Experts









- [Overview](#overview)
- [Services](#services)
- [Expertise & Advantage](#expertise)
- [Insights](#insights)







## Medical Device Registration In the US & Canada







The North American medical device market is one of the most attractive and highly regulated in the world. In the United States, medical device registration is overseen by the FDA, primarily through the Center for Devices and Radiological Health (CDRH), while in Canada, it is governed by Health Canada under a risk-based framework.

For manufacturers, navigating these markets can be complex. Both countries rely on risk-based medical device classification (Class I, II, III, and in Canada, Class IV), backed by robust evidence of safety and performance and a compliant quality management system (QMS). Programmes such as MDSAP and standards like ISO 13485, along with differing terminology, pathways, and documentation expectations, add further layers of complexity when planning entry into the US and Canadian markets.

Freyr helps manufacturers turn this complexity into a clear, actionable plan for the US and Canada market access. We understand how FDA requirements and Health Canada medical device regulations intersect, and we support you in aligning classifications, evidence, QMS, and dossiers so you can follow a single, efficient strategy for approvals, launches, and long-term compliance in both countries.

#### USA vs Canada

### Medical Device Registration Process - Comparison Chart

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## Freyr’s Medical Device Registration Services

##### MDV Americas main Menu

- [USA](/index%2ephp/medical-devices/us-fda-medical-device-registration)
- [Canada](/index%2ephp/medical-devices/health-canada-medical-device-registration)
 
 











## Medical Device Registration in The Americas



- [Expertise](#mdv-1)
- [Advantages](#mdv-2)

- Regulatory and Market Intelligence Support
- Product Classification as per Regulatory requirements
- Medical Device Registration USA -513 (G) & (Right Pathway among 510 (K)/De-NOVO/PMA/IDE)
- Pre-Submission Meeting with Health Agencies
- Regulatory Support for Product Documents such as, Design History File (DHF)
- Gap Analysis of the Technical Documents & Good Manufacturing Practice (GMP) Systems
- Regulatory Support for Technical File Compilation as required by respective Registration Pathway
- USFDA Quality System Compliance Strategy (21 CFR 820)
- Medical Device Single Audit Program (MDSAP) compliance services
- Medical Device Registration Canada-Medical Device License (MDL) and Medical Device Establishment License (MDEL) Registration
- Health Agency Liaising and support
- In-Country Representation – U.S. Agent and Sanitary Responsible Person Services
- Post Approval Compliance activities



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- Successful submissions for varied class of devices ranging from software to sutures
- Local affiliate access to meet the challenges of authority and language-specific requirements
- Dedicated and expert personnel to provide Medical Device and IVD Regulatory support
- Cost-effective model for In-country or Legal representation support
- Have successfully delivered various projects across U.S. and Canada
- Headquartered in the U.S.



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[Book a meeting with our experts today](javascript:void(0))





## Why Partner with Freyr?



- End-to-end North America regulatory expertise, supporting everything from FDA and Health Canada pre-market notification (submissions) to post-market surveillance and lifecycle compliance.
- Proven success across 1500+ global medical device registrations, spanning Class I–III devices in the US and Class I–IV devices in Canada.
- On-ground presence through US Agent services and Canadian regulatory support, backed by globally distributed expert teams for seamless execution.
- Integrated US & Canada strategy that streamlines evidence, documentation, and quality requirements to reduce cost, duplication, and approval timelines.
- Direct engagement with FDA and Health Canada, ensuring clear communication, timely responses, and proactive alignment with regulatory expectations.
- Trusted by 470+ medical device manufacturers worldwide, from start-ups to global enterprises, as their long-term North America regulatory partner.



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## Celebrating Customers Success



 

Medical Devices



Registration and LR Support



Global





Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.



 ![Regulatory Affairs](/sites/default/files/clients-speaks-logos/mdv-logo4.webp)

##### Arie Henkin  
VP - Quality and Regulatory, Australia -based, Leading SaMD Company















Medical Devices



Swiss Rep Services



Japan and Switzerland





I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.



 ![Regulatory Affairs](/sites/default/files/clients-speaks-logos/mdv-logo3.webp)

##### Darren Mansell  
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company















Medical Devices



Registration and AR Services



Malaysia and Indonesia





Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.



 ![Regulatory Affairs](/sites/default/files/clients-speaks-logos/mdv-logo2.webp)

##### Robert Menadue  
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company

















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## Frequently Asked Questions





#### [What is the process for medical device registration in the US? ](#collapseOne)



US FDA medical device registration involves determining medical device classification, selecting the correct FDA regulatory pathway (such as 510(k) premarket notification, De Novo, or PMA), preparing technical documentation, and ensuring compliance with FDA Quality System Regulation (QSR/QMSR). Manufacturers must also complete FDA medical device Establishment Registration and Listing before marketing their devices in the United States.







#### [How does Health Canada medical device registration differ from the US FDA registration? ](#collapseTwo)



In Canada, medical devices are regulated by Health Canada using a four-class risk framework (Class I–IV). Most Class II–IV devices require a Medical Device License (MDL), while manufacturers, importers and distributors often need a Medical Device Establishment License (MDEL). Unlike the US 510(k) process, Canada focuses on safety, effectiveness and QMS evidence aligned with ISO 13485 and MDSAP.







#### [What is the difference between an MDL and an MDEL in CANADA? ](#collapseThree)



An MDL (Medical Device License) authorizes a specific device to be sold in Canada, based on its safety, effectiveness and intended use. An MDEL (Medical Device Establishment License) applies to companies conducting regulated activities such as manufacturing, importing or distributing devices. Many organizations require both an MDL and MDEL to operate compliantly under Health Canada medical device regulations.







#### [Which FDA regulatory pathway should I choose - 510(k), DE NOVO, or PMA? ](#collapseFour)



Your FDA pathway depends on your device’s risk, novelty and availability of predicate devices.

- 510(k) is for devices demonstrating substantial equivalence to an existing device.
- De Novo is for novel, low- to moderate-risk devices with no predicate.
- PMA is required for Class III medical devices needing substantial clinical evidence.  
    A correct pathway decision is a key part of your US FDA medical device registration strategy.







#### [Do foreign manufacturers need a US agent or Canadian representative? ](#collapseFive)



Yes. Foreign manufacturers selling medical devices in the US must appoint a US agent to support FDA communications, inspections and compliance activities. In Canada, manufacturers outside the country often rely on a licensed Canadian importer or distributor to meet MDEL obligations and coordinate with Health Canada.







#### [What Quality Management System (QMS) requirements apply in the US & Canada? ](#collapseSIx)



In the US, devices must comply with FDA QSR/QMSR, including design controls, CAPA and production controls. In Canada, manufacturers typically need ISO 13485 certification, and participation in MDSAP is often required for Class II–IV MDL submissions. Both countries expect robust QMS documentation to support medical device registration and post-market compliance.







#### [How long does FDA or Health Canada approval take? ](#collapseSeven)



FDA review timelines vary. Some 510(k) submissions may be cleared within a few months, while PMA approvals can take significantly longer. For Canada, MDL review timelines depend on device class, Class II medical devices may move faster, while Class III and IV require more extensive evidence and review. Strong documentation and a clear regulatory strategy help minimize delays in both markets.







#### [How can Freyr help with medical device registration in the US and Canada? ](#collapseEight)



Freyr provides end-to-end support for US & Canada medical device registration, including device classification, FDA pathway selection, 510(k)/De Novo/PMA preparation, MDL/MDEL applications, QMS alignment (ISO 13485 & MDSAP), US FDA agent services, and post-market compliance. We help manufacturers build a unified North America regulatory strategy that accelerates approvals and reduces regulatory risk.