Refine by MP, party, committee, province, or result type.

Results 31-45 of 356
Sort by relevance | Sorted by date: newest first / oldest first

Health committee  Indeed the government is certainly committed, as indicated in the mandate letter of Minister Hajdu, to support and work with the provinces and territories and other partners to increase the financial support and resources to help Canadians get mental health services and, indeed, develop standards so they know what to expect.

March 31st, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  Indeed, on May 9, Health Canada cancelled the authorization for the importation and sale of a KN95 respirator and, in addition, contacted a number of other MDEL-holders to change the labelling, which does represent a recall in the definition we use to indicate that they don't meet the N95 filtration standards.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  We have the information on the MDELs. We ensure that the information provided is accurate. In terms of their use, they're utilized at the provincial level or local level further to the guidance and conditions of use that represent their authorization.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  Of the medical device establishment licences issued.... I believe they're manufactured here or imported, so we have the information, and I believe the Canada Border Services Agency has it in regard to the import of those products.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  No. In regard to the regulatory authorization issued by Health Canada, we are the authority that issues recalls or instruction to manufacturers or to medical device establishment licence-holders to change their labelling, as was done in the case of 20 or so MDEL-holders associated with the KN95 masks that didn't meet the NIOSH standard.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  These are companies that had achieved a medical device establishment licence on the basis of meeting Canadian or equivalent standards. The further assessment that was done initially in the United States determined that they didn't meet the N95 standard, and as a consequence, information through public advisory and direct contact with the companies was issued on an expedited basis on May 10 and May 11.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  We became aware of the USFDA's revised guidance on May 7 and acted rapidly to assess that. On May 10, we contacted the medical device establishment licence- holders to indicate that the labelling needed to be changed, and we issued a public advisory on May 11. On May 9, we cancelled the authorization to one company in regard to the KN95 masks.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  I don't have the specific supplier names here. When information comes to us on false [Technical difficulty—Editor] claims or counterfeit materials, our compliance and enforcement officers work on it immediately and take appropriate action, including referral to law enforcement officers.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  That's not what I said. I said that as information comes to our knowledge, be it information in Canada or from another country, we act on it immediately in terms of identifying the supplier and issuing the appropriate compliance and enforcement action. If there's non-compliance, it's referred to law enforcement officers.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  We authorize medical devices, including personal protective equipment, based on our assessment or in reference to an evaluation of assessments granted by other regulatory authorities in whom we have confidence. Certainly, in the Government of Canada's procurement, we test the materials to ensure that they meet standards.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  In terms of Health Canada's role as a regulatory authority, we would not issue guidance to have non-medical masks relabelled as medical. Should information that this is occurring come to our attention, we would ensure that appropriate compliance and enforcement action is taken immediately.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  Indeed, building on Minister Hajdu's comments, Health Canada and the Public Health Agency are working with Innovation, Science and Economic Development Canada, the National Research Council and other partners not only to do the fundamental research, as Dr. Strong spoke about, through the Canadian Institutes of Health Research, but also to work to build the manufacturing capacity in Canada to enable that.

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  Mr. Chair, as I indicated, Health Canada became aware of the U.S. FDA-issued revised guidance on May 7 after—

May 22nd, 2020Committee meeting

Dr. Stephen Lucas

Government Operations committee  The information provided to us through the testing undertaken and the revised guidance on the utilization of the masks was completed on May 7. We looked at the work done by the National Institute for Occupational Safety and Health and identified the specific medical device establishment—

May 22nd, 2020Committee meeting

Dr. Stephen Lucas