The first step in determining what regulatory pathway will be required for your medical device is to properly classify your medical device. Medical Devices in both the United States and Canada are classified based on risk, with regulatory oversight increasing with each class.
The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the regulatory body responsible for licensing Medical Devices in Canada.
Below are the following types of submissions dicentra can help prepare in Canada:
- Medical Devices Active Licence Listing (MDALL) – an MDALL is provided for all licenced Class II-IV devices
- Medical Device Establishment Licence (MDEL) – Class I medical devices require an MDEL
- Medical Device Licence (MDL) – Class II-IV medical devices require an MDL
- MDEL Renewal – annual renewal is required for all MDEL holders
The Federal Drug Administration (FDA) is the regulatory body responsible for licensing medical devices in the United States
Below are the following types of submissions dicentra can help prepare in the United States:
- Establishment Registration – An establishment registration, or facility registration, is required for all medical devices
- Medical Device Listing (FURLS) – All medical devices require a FURLS listing
- Premarket Notification 510(k) – A 510(k) notification is required for Class II and Class III medical devices
- Premarket Approval (PMA) – Class III medical devices require a PMA
- De-Novo Classification – A De-Novo Classification is available for Class I and II non-predicate devices by way of a De-Novo classification request
- In-Vitro Device (IVD) Registration – like other medical devices, IVD’s are subject to premarket and postmarket controls, however are also subject to specific requirements such as additional labeling requirements, Good Clinical Practices (GCP) requirements, CLIA ’88 requirements, etc.
- Investigation Device Exemption (IDE) for Clinical Studies
Contact our medical device specialists using the form below for support with medical device regulatory submissions