R
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
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