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Industry committee Thank you, Raj. Along with what you mentioned, we have not heard of such concerns. In fact, some companies, as you mentioned, went above and beyond and posted the designs for their ventilators for others to use. If anything, we saw huge collaboration during COVID.
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee If I can add one more piece to what you mentioned, Raj, we fully support regulated third party servicing of medical devices as integral to health care. However, our concern is the regulations.
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee Do you want me to try to explain our concerns around clause 2? Is that your question? I'm sorry. Could you paraphrase, perhaps?
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee I can only speak to the impact that these two clauses have on regulated medical devices. We have equal concern with regard to clause 1 and clause 2, specifically around the parts components in clause 2. As you know, some components of medical devices go into contact with humans—b
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee We mentioned the example of Vanessa's Law. The current law requires a regulated industry to provide certain reporting. For example, you have to report to the government in 10 days if there was a death or near death, or should it recur in 30 days. This is an example. Vanessa's Law
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee It's problematic to our patients and our health care providers and to Health Canada to ensure ongoing safety monitoring of our patients.
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee I'm fully aligned with my colleague's feedback. In addition to what he mentioned, any medical device that has software, hardware or a combination of both of them would be something we would seek exclusion for. It doesn't have to be a specific MRI machine or any high-tech device;
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee Yes. Go ahead, Mr. Malik.
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee In addition, we have provided feedback to Health Canada around this area.
November 14th, 2022Committee meeting
Mia Spiegelman
Industry committee Thank you, Mr. Malik. When Vanessa's Law was enacted, it had different sections. One of them talks about the safety of the medical device throughout its life cycle. As Mr. Malik mentioned, it could be seven to 15 years. In the medical device industry, they implemented it such t
November 14th, 2022Committee meeting
Mia Spiegelman