AMERICA

 

The requirements for approvals in

North, Middle and South America

vary extremely. Following you will find a short version of the existing requirements.

  • Northamerica

Canada

Depending on their classification the products either need to be registered or licensed. Health Canada requires:

  • certification according to CAN/CSA ISO 13485 
  • listing for class 2 products 
  • product documentation for products in classes 3 and 4 

 

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:

pdf download

 

 

 

 

 

 

 

Should you require any assistance please contact us.

 

USA

FDA approval / 510 (k)

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.

  • Middle America

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:

Mexiko:

NEW:

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.

  • South America

 

We will also assist you with regard to the specific approval for:

  • Argentina
  • Brazil
  • Columbia
  • etc.