MDEL Annual License Review: Everything You Need to Know
To continue operating under an active MDEL, holders must apply for an annual license review (ALR). This renewal is mandated under Section 46.1 of the Canadian Medical Devices Regulations. In this blog, we have discussed the MDEL annual license review process....
Health Canada Updates: 4 Proposed Changes in Phase II of MDEL
Canada has classified medical devices into four classes based on risk level associated with the device. Although Class I medical devices are lowest risk devices, companies are still required to abide by certain regulatory obligations. To operate legally in Canada,...
Health Canada MDL Technical File Preparation: 7 Pro Tips
Health Canada is the apex regulatory body for ensuring safety, effectiveness, and quality of medical devices entering the Canadian market. Complying with Health Canada medical device regulations is a must to launch your product in Canada. Moreover, you have to secure...
Separate Provision for Subsequent Importers of Approved Medical Devices
To simplify and expedite the import process for already-approved medical devices and IVDs, CDSCO has implemented a new provision. A circular dated 15.9.25, states that w.e.f 11.9.25 a separate provision for “Subsequent Importers” of already-approved...