Our expertise on U.S. and Canadian market access will accelerate your time to market.
Avoid costly missteps
As a medtech company, entering the U.S. and Canadian markets is essential but can quickly become overwhelming due to complex and evolving regulatory frameworks. In the U.S., navigating FDA classification, 510(k), De Novo, or PMA routes requires deep understanding and precise strategy.
In Canada, companies must meet stringent Health Canada requirements under the Medical Device Regulations (SOR/98-282), including licensing, labeling, and mandatory monitoring programs. For non-domestic manufacturers, the need for an official U.S. or Canadian agent adds another layer of complexity. Without expert guidance, market access can be delayed and the business planning will be interrupted due to regulatory shortcomings.
We at Qserve can act as your regulatory and strategic bridge to the U.S. and Canadian markets. From identifying the correct submission route to acting as your U.S. or Canadian regulatory agent, we ensure compliance, accelerate timelines, and optimize your path to market. Our team helps you avoid costly missteps by managing the details of submission strategy, product classification, labeling compliance, and ongoing regulatory obligations.
Approved 510(K)'s
Countries for market access
Discover how we can help:
Market Access U.S.
We guide you through FDA regulatory strategy, classification, and submissions—whether 510(k), De Novo, or PMA—while aligning reimbursement and commercial considerations.
U.S. Agent
We act as your official U.S. Agent, serving as the FDA liaison and supporting communication, registration, and compliance for non-U.S. medical device manufacturers.
Market Access Canada
We provide end-to-end support for Health Canada licensing, product classification, regulatory strategy, and device license applications.
Entering North America without a sound regulatory and market strategy often results in delays for market approval, misclassification, missing documentation, or poor communication with authorities can delay market entry and increase the risk of rework or rejection, which ultimately impacts revenue, partnerships, and patient access.
By combining regulatory, strategic, and operational expertise, we streamline your path to FDA clearance and Health Canada licensing. We manage every detail, minimizing regulatory risk, ensuring a faster time to market.
Couldn't find your question?
What's the difference between U.S. and Canadian regulatory pathways?
The U.S. requires device clearance through the FDA (510(k), De Novo, or PMA), while Canada requires licensing through Health Canada, each with different classification rules and submission requirements.
Do I need a local agent to enter the U.S. or Canadian market?
Yes. Non-U.S. and non-Canadian manufacturers must appoint a U.S. Agent or Canadian regulatory representative to communicate with the respective authorities and ensure regulatory compliance.
Why do I need an U.S. Agent?
The Federal Drug Administration (FDA) requires a US Agent for foreign establishments that manufacture, prepare, or process devices imported into the United States. The US Agent must reside in the United States and be available to answer questions from the FDA during business hours. An Official Correspondent is designated as the individual responsible for maintaining the registration and device listing account during registration. Qserve acts as the US Agent and the Official Correspondent for establishments registered with the FDA.
What is included in the US Agent service?
- Assist FDA in communication with the foreign manufacturer
- Initial registration of the new establishment
- Annual update of registration and device listing records
- Assist FDA in scheduling inspections of the foreign establishment
- Initial listing of medical devices that will be imported
- Two hours of regulatory support/advice
- Qserve template to facilitate importation
What are the responsibilities of an U.S. Agent?
- Assist FDA in communications with the foreign establishment
- Respond to questions concerning the foreign establishment's devices that are imported or offered for import into the United States
- Assist the FDA in scheduling inspections of the foreign establishment
What are the responsibilities of the official correspondent?
- Manage registration and device listing accounts in the FURLS system (FDA Unified Registration and Listing System)
- Responsible for annual renewal of the FDA establishment registration
- Receives correspondence from the FDA for the registration and listing information for the foreign establishment