FredLaBosche

Inactive Registered Visitor
#1
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
 

sreenu927

Quite Involved in Discussions
#3
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
 

RA Guy

Involved In Discussions
#5
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_formats/hpfb-dgpsa/pdf/md-im/risk5_risque5-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
 

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