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Classification of Medical Device Fastener in Canada (EU classification IIa)

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Some Related Topic Tags
canada, class ii medical device, class iii medical device, fasteners (category - nuts bolts and others), medical device listing codes and classifications, classification(s) of parts or products
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  Post Number #1  
Old 22nd June 2011, 04:34 AM
FredLaBosche

 
 
Total Posts: 13
Please Help! Classification of Medical Device Fastener in Canada (EU classification IIa)

I need some advise about what class the following product may receive in Canada:

Product:
A flexible fascia / fastener / patch used for temporary closing abdominal wounds.

Usage:
- in abdominal cavity to avoid effects of abdominal high-pressure
- for temporary closing abdominal wall

EU classification is IIa, so corresponding class in Canada should be III. Would that be correct or is it possible to receive a Class II in Canada?

Thanks in advance

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  Post Number #2  
Old 22nd June 2011, 05:37 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: Classification of Fastener (EU classification IIa)

Can someone lend Fred a hand?

Thank you!!

Stijloor.
Thanks to Stijloor for your informative Post and/or Attachment!
  Post Number #3  
Old 22nd June 2011, 11:08 PM
sreenu927

 
 
Total Posts: 541
Re: Classification of Medical Device Fastener in Canada (EU classification IIa)

EU classification could only be a reference. however, need to follow classification rules from Health Canada MDR.

To find out the classification of the device, first you must have the Intended use statement followed by how used, whether invasive or non-invasive, and according to that need to go through the rules for classification.

From the usage provided by you, I tried to give some information on the class, as below:

As per Health Canada Medical Device Regulations,

Rule 4:
(1) Subject to subrule (2), all non-invasive devices that are intended to come into contact with injured skin are classified as Class II.
(2) A device described in subrule (1) that is intended to be used as a mechanical barrier, for compression or for absorption of exudations, is classified as Class I.

Rule 6:
(1) Subject to subrules (2) and (3), a non-invasive device intended for modifying the biological or chemical composition of blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class III.
(2) A device described in subrule (1) whose characteristics are such that the modification process may introduce a foreign substance into the body that is potentially hazardous, taking into account the nature and quantity of the substance, is classified as Class IV.
(3) A device described in subrule (1) that accomplishes the modification by centrifugation, gravity filtration or the exchange of gas or heat is classified as Class II.

Just check it out!

Regards
Sreenu
Thanks to sreenu927 for your informative Post and/or Attachment!
  Post Number #4  
Old 23rd June 2011, 07:13 AM
DannyK

 
 
Total Posts: 677
Re: Classification of Medical Device Fastener in Canada (EU classification IIa)

I would recommend that you refer to the Health Canada document
"Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices" The link is http://www.hc-sc.gc.ca/dhp-mps/md-im...scles2-eng.php

It is also possible to contact Health Canada with specific classification questions.
Thanks to DannyK for your informative Post and/or Attachment!
  Post Number #5  
Old 23rd June 2011, 10:33 AM
RA Guy

 
 
Total Posts: 70
Re: Classification of Medical Device Fastener in Canada (EU classification IIa)

I did not see it posted, but here is a link to the current draft classification guidance.
Although its only guidance and in a draft state, this document has stood unchanged on Health Canada's website for a very long time and is still quite relevant.

http://www.hc-sc.gc.ca/dhp-mps/alt_f...isque5-eng.pdf

If you know of any competative device that is sufficiently similar to your, you could check to see if it it licenced here on the active product database (MDALL):

http://webprod.hc-sc.gc.ca/mdll-limh/index-eng.jsp
  Post Number #6  
Old 24th June 2011, 05:07 AM
FredLaBosche

 
 
Total Posts: 13
Re: Classification of Medical Device Fastener in Canada (EU classification IIa)

According to the index it seems to be Class 3, however I will contact Health Canada to make sure.

Thanks all!
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