Canada classification of spring-driven autoinjector

R

Reinheitsgebot

Does anyone have a view on the correct classification of a spring-driven autoinjector under HC classification rules?

My reading at the moment is that probably Rule 11 for active devices intended to administer drugs applies, which makes the autoinjector a Class II device.

The autoinjector is primed by manually pushing back on an internal spring mechanism, then a pre-filled standard piston syringe is placed in the autoinjector. On activating the autoinjector the spring mechanism pushes on the syringe plunger to deliver the drug injection.

My thinking is that the stored energy of the spring mechanism, albeit manually primed, makes the autoinjector an active device.

For reference the US FDA classification of this device would be Product Code KZH, Regulation Name: Syringe Needle Introducer.

Many thanks for any advice or comments!
 
D

DannyK

Trusted Information Resource
Reinheitsgebot said:
Does anyone have a view on the correct classification of a spring-driven autoinjector under HC classification rules?

My reading at the moment is that probably Rule 11 for active devices intended to administer drugs applies, which makes the autoinjector a Class II device.

The autoinjector is primed by manually pushing back on an internal spring mechanism, then a pre-filled standard piston syringe is placed in the autoinjector. On activating the autoinjector the spring mechanism pushes on the syringe plunger to deliver the drug injection.

My thinking is that the stored energy of the spring mechanism, albeit manually primed, makes the autoinjector an active device.

For reference the US FDA classification of this device would be Product Code KZH, Regulation Name: Syringe Needle Introducer.

Many thanks for any advice or comments!
Click to expand...

I had a client with a similar product and it was classified as class II.
You can contact Health Canada and they can provide the correct classification.
 
R

Reinheitsgebot

Thank you DannyK for your reply and information, it's very much appreciated and very useful to know that a similar device has been classified Class II.
 
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