False information provided for Medical Device Registration - What are the implications?

[JoCam]

Hi All,

Firstly, this issue is not related to my organisation.

If a medical device manufacturer was to provide false information to obtain a medical device licence for a class II or above medical device, what would happen if this was identified by another organisation or auditor. Would the manufacturer just be requested to remove the device from the listing or would there be repercussions such as fines or disqualifications, even if none of the devices had yet been sold in the country concerned.

Jo

 

[HamaMarcus]

The law can differ from country to country, what couintry you are talking about?

 

[JoCam]

The law can differ from country to country, what couintry you are talking about?

All I suppose, but mainly Canada and Australia.

Jo

 

[Sidney Vianna]

Hi All,

Firstly, this issue is not related to my organisation.

If a medical device manufacturer was to provide false information to obtain a medical device licence for a class II or above medical device, what would happen if this was identified by another organisation or auditor. Would the manufacturer just be requested to remove the device from the listing or would there be repercussions such as fines or disqualifications, even if none of the devices had yet been sold in the country concerned.

Jo

There is always a risk for terrible advice and feedback when someone asks a question about legal implications and liability issues in a discussion group, mainly populated by technical people without in-depth knowledge of the law. Even worse, when the information provided and the context is so scarce.