Inquiry for Class II medical device licence amendment application

B

bennylee

Hi All,

Our company would like to add one model (same intended for use) in the existing "group family class II medical device licence", we planed to use "Licence Amendment Application form" to apply,
When fillin the form, we are not very clear about the application process for some item as the following part:

Question (1)
For Item 7: ATTESTATIONS about
  • Attestation of Safety and Effectiveness Requirements
  • Attestation of Labelling Requirements
Do we need to submit any evidence document during application?

Question (2)
Item 13: LIST OF RECOGNIZED STANDARDS COMPLIED WITH IN THE
MANUFACTURE OF THE DEVICE
  • Actually, products are designed based on the following standard
    1. IEC 60601-1:2005 IEC 60601-1-2:2007 IEC 60601-1-6:2010
    2. ISO 10993-5:2009 ISO 10993-10:2010 ISO 14155:2011
    3. ISO 14971:2007 IEC 62304:2006
  • But for 3rd party test report, we only have IEC 60601-1:2005 IEC 60601-1-2:2007 (for other standard, we use self-declaration with internal test), is it better we only mention IEC 60601-1:2005 IEC 60601-1-2:2007?

Thanks,
Benny
 

DannyK

Trusted Information Resource
Re: Inquiry for licence amendment application

For class II devices there is no need to submit additional documents. You just need to sign the attestation. Just list the standards that apply. There is a list that you can find at the health Canada site with the list of acceptable standards for health Canada.
 
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