Regulatory Pathways

Health Canada

Health Canada In Vitro Device (IVD) Approvals Or Canadian Medical Device License (MDL)

Companies selling Class II - IV medical devices in Canada are required to apply for and receive MDLs before they can sell the device legally in the Canadian Market. Depending on the class of device, timelines for securing MDLs can vary e.g. getting an MDL for a Class ll device is faster than that of a Class lV device.

Medical Device Establishment Licence (MDEL)

importing or distributing (selling) class I medical devices for human use in Canada require MDEL. The MDL is a product approval i.e. this approval is tied up with a specific medical device, while an MDEL is a permit for the company/distributor/importer itself.

Medical Device Single Audit Program (MDSAP)

In order to minimize the medical device manufacturer disruption due to multiple regulatory audits, the Government of Canada is transitioning to MDSAP. MDSAP allows medical device manufacturers to be audited only ONCE for compliance with the standard regulatory requirements of up to five different device markets i.e. Australia, Brazil, Canada, Japan and the United States of America.

FDA – Food and Drug Administration

Premarket Notifications (PMN) Or 510(K) Clearance

For anyone who wants to market class l, ll or lll medical devices within the US that are intended for human use, for which premarket approval is not required, must submit a 510(k) clearance request unless the device is 510(k) exempt. The 510(k) is an FDA guidance document based on 21 CFR part 807. The major goal of a 510(k) submission is to demonstrate to the FDA that the device to be marketed is as safe and effective or substantially equivalent to a legally marketed device.
Reference: https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

Premarket Approval (PMA)

PMA is an FDA process which involves scientific and regulatory review to evaluate the safety and effectiveness of class lll devices. PMA approval is based on the determination by FDA that the PMA contains sufficient and valid scientific evidence to assure that the device is safe and effective for its intended use(s).
Reference: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma