Is this Orthodontic Retainer Component a Medical Device in Canada?

[romeotang]

Hello,

I am having a hard time determining whether the product I will be manufacturing is a medical device in Canada.

The product is a component that will be adapted onto other components and materials (steel wires and polymerized acrylic) to form a custom made orthodontic retainer. Our component is then customized by the dental technician to form the patient's dental arch for tooth stabilization according to the prescription made by the dental professional. This orthodontic appliance is then sent to the orthodontist or dentist for the patient to use.

I am aware of rules 1,2 and 3 on schedule 1 section 6 in the classification rules for medical devices on the Health Canada website.

I am curious to know if you think this component is a medical device, if so why?

Thank you,

Jason

[DannyK]

I checked the mdall.ca website and there are class 2 licenses issued for orthodontic retainers.

[arios]

Custom made devices are covered by Part 69-78 of the Canadian Medical Device Regulation.

http://www.canlii.org/en/ca/laws/reg...or-98-282.html

I hope it helps

[romeotang]

Hi DannyK,

Thanks for getting back to me, much appreciated.
The component we will be supplying is not an orthodontic retainer. It's a component that needs to be adapted and customized by the orthodontic technician (The buyer of our component) to meet the specific requirements of the dental professional.

Once adapted with the rest of the components, it forms a customized orthodontic retainer for the patient. This orthodontic retainer is sent from the laboratory to the dental professional's office.

After seeing that this device is not subject to the MDD regulation, I was wondering why it would be for Health Canada's regulations.

I found this link (Refer to the second question)
http://www.gdc-uk.org/Newsandpublica...ppFAQMay10.pdf

Thanks!
Jason

[DannyK]

Hi,

I performed an ISO 13485 CMDCAS audit on a company that manufactured orthodontic archwire. (class 2)

I would encourge you to contact Health Canada to be sure if it is classified as a medical device.

[bdsix]

It will be a Class II. Not sure why, but Orthodontic manufacturers like to use this custom made device defence a lot Be happy that Orthodontics has/had a strong lobby and avoided the "30 day rule" that the rest of the dental industry needs to deal with.

[romeotang]

Thanks for the reply Danny. I will do that tomorrow and post here what they say.