Canada Regulation (RIM), Australia (TGA)

[iam1235]

Hello,
I'm about to start a new job as a regulatory affairs officer. The company is a multinational based in France, and I'll be responsible for registering ophthalmology medical devices. Do you have any guidelines or guides explaining how to proceed with registration (this is my first experience in registration).
Thank you

 

[shimonv]

Hi iam1235,
My first advise to you is to find a good consultant to work with. You will have far too many and frequent questions that this cove can help you with.

Regarding Australia, refer to these resources:
https://www.tga.gov.au/resources/re...n-regulatory-guidelines-medical-devices-argmd
https://www.legislation.gov.au/Details/F2023C00032

Regarding Canada, refer to these resources:
https://www.canada.ca/en/health-can...plication-information/guidance-documents.html
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/

Welcome to the world of RA.

Shimon

 

[iam1235]

Hi iam1235,
My first advise to you is to find a good consultant to work with. You will have far too many and frequent questions that this cove can help you with.

Regarding Australia, refer to these resources:
https://www.tga.gov.au/resources/re...n-regulatory-guidelines-medical-devices-argmd
https://www.legislation.gov.au/Details/F2023C00032

Regarding Canada, refer to these resources:
https://www.canada.ca/en/health-can...plication-information/guidance-documents.html
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/

Welcome to the world of RA.

Shimon

I thank you for the interesting links, but would you have a document that summarizes the steps of registration in order to have an idea before.
Thank you,

 

[shimonv]

Sorry, I don't have a process flow chart... honestly it's much more complicated than you think.
Perhaps you should look for a course or book about fundamentals of medical device regulations, like from RAPS.org.

​

Shimon

 

[iam1235]

Sorry, I don't have a process flow chart... honestly it's much more complicated than you think.
Perhaps you should look for a course or book about fundamentals of medical device regulations, like from RAPS.org.

​

Shimon

I see, thank you so much

 

[DannyK]

The first step is to determine the classification of the devices in Canada.
After the classification the route to conformity is clear.
For class I devices, you will need to obtain a Medical Device Establishment License.
For classes II, III or IV, you will need to get an ISO 13485:2016/MDSAP certificate.
Please feel free to ask more questions.