Medical Device Registration in The Americas

The United States (US) medical device market is regulated by the US Food and Drug Administration (FDA), and manufacturers are required to navigate the registration pathways based on device risk classification to place their devices on the market. Pharma Wizard’s expertise encompasses Regulatory intelligence and strategy, product classification, identification of US FDA’s registration pathways (510(k)/De-NOVO/PMA/IDE), and more.

Overview

Services

Expertise & Advantages

Medical Device Registration Overview

The U.S. and Canada are highly attractive markets for medical devices due to strong demand and well-defined regulatory frameworks. However, navigating region-specific requirements—such as the U.S. mandate for a registered agent—can be challenging. Pharma Wizard offers end-to-end regulatory support for all classes of devices, from software-based to IVDs, ensuring smooth market entry.

Our Presence

The United States of America is a highly regulated and competitive market with scores of medical devices and IVDs receiving approvals each year. Medical devices in the USA are regulated by the Center for Devices and Radiological Health (CDRH) under the Food and Drug Administration (FDA).

U.S.

Medical Device Registration USA

CDRH Medical Device approvals in the US are achieved through any of the registration pathways. The appropriate pathway is determined by a risk-based medical device classification system.

Medical Device Classification USA

Device Class	Risk	Registration Pathway for Approval
I	Low Risk	510(k) exempt
II	Moderate Risk (With predicate device)	Premarket Notification / 510(k)
II	Moderate Risk (Without predicate device)	De-Novo application
III	High Risk	Premarket Approval (PMA)

Companies lacking a local presence in the U.S. are required to appoint a U.S. Agent.

Canada has one of most stringent regulatory systems for medical devices. All the medical devices in Canada are regulated by Health Canada

Medical Device Registration Canada

Regulatory pathway is determined upon risk-based classification of the device.

Device Class	Risk	Regulatory Pathway
I	Low	Medical Device Establishment License (MDEL)
II	Low-Moderate	Medical Device License (MDL)
III	High-Moderate	Medical Device License (MDL)
IV	High	Medical Device License (MDL)

There is no requirement for the manufacturer to appoint an Authorized Representative in Canada.

Pharma Wizard Medical Device Registration Services

USA

Seamless registration for medical devices in the US market.

Canada

Streamlined registration process to enter the Canadian medical device market.