Depending on their classification the products either need to be registered or licensed. Health Canada requires:
These approvals are to be updated regularly.
On top of that according to the Electrical Safety Code all electrical equipments including medical devices need to have a SCC accredited safety mark.
NEW: Since 01. April 2009 and with a transition until mit 30. August 2009 all manufacturers intending to sell electrical equipments including active medical devices into Ontario need to register themselves in the ESA database.
More information can be found in our:
Should you require any assistance please contact us.
To bring your products onto the market most of the products require the '510(k) approval'.
With this documentation the substantial equivalence as well as the safety and effectiveness to the predicate device has to be provided.
Assisting you in compiling the documents and the subsequent communication with the FDA and/or Third Party is part of our service.
The current regulations in middle america sometimes lead to delayed market introductions for medical devices.
This aspect was recognized by the governmental authorities as well and as one of the first countries Mexico reacted on this:
Dated October 26th 2010 the governmental authority COFEPRIS published a simplified approach for the registration of FDA or Health Canada listed products.
Further details can be found in our flyer under Downloads.
For all other products the former registration scheme remains as it it was before.
We will also assist you with regard to the specific approval for: