The FRED easy G2 is approved for sale in Canada and Quebec under Health Canada regulations. However, it was subject to a recall in 2019 due to possible internal damage after a fall of more than one meter. This recall did not remove the product from the market, and Schiller has taken the necessary measures to ensure its compliance and safety. The product remains available today and is used in a variety of medical settings.
Approach proposed by Inovago
1. Analysis of local regulations: Verification of approval standards and integration of Health Canada requirements to ensure compliance of FRED devices.
2. Product positioning: Creation of a specific branding campaign to promote the safety and effectiveness of the FRED easy G2 defibrillator, while highlighting its approval and certifications.
3. Digital visibility: Development of digital campaigns on specialized platforms and optimization of online content to attract Quebec healthcare professionals.
Schiller.ch medical devices are licensed in Canada, but it depends on their class. For Class II, III, or IV devices, they require a valid license (MDL) to be sold or imported into Canada, in accordance with Health Canada regulations. Class I devices do not require this license, but their importer must have an establishment license (MDEL) to be able to distribute them. You can consult Health Canada's Active Medical Devices database to check if a specific Schiller.ch product is authorized in Canada. If you want to check the license of specific medical devices, you can consult the list of active medical device licenses.