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Mr. Don Boyer, RAC, FRAPS

President, BOYER@RegulatorySolns

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President, BOYER@RegulatorySolns
Canada

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1 to 5 of 6 total

RE: Health Canada/MDSAP Requirement: Importer of Record

Posted By Don Boyer 28-Apr-2021 12:06
Found In Egroup: Regulatory Open Forum \ view thread
Hi there. Wonder if you can elaborate on the "importer of record" citation? I assume you are based outside of Canada and have an importer based in Canada? That importer needs a MDEL to operate in compliance with Canadian MDRs. Assume for the purposes of ISO 13485 / MDSAP you would consider them as a ...

RE: Health Canada void medical device licence - and existing customers

Posted By Don Boyer 03-Oct-2019 05:51
Found In Egroup: Regulatory Open Forum \ view thread
Soichiro, Yes there is an annual "right to sell" (licence renewal) fee which is applicable to all Class II, III and IV licences. As of April 1, 2019 the fee is just under $400 CDN. Historically, this fee increases each year at a rate of approximately 2%. A new fee structure is scheduled to be implemented ...

RE: Health Canada void medical device licence - and existing customers

Posted By Don Boyer 02-Oct-2019 06:28
Found In Egroup: Regulatory Open Forum \ view thread
Dear Soichiro, Whether you need to maintain a licence is a very good question. Before I respond, I want to point out wording in the definition of a "device" in the Canadian Food and Drugs Act: "device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including ...

RE: Health Canada void medical device licence - and existing customers

Posted By Don Boyer 01-Oct-2019 05:43
Found In Egroup: Regulatory Open Forum \ view thread
As you have pointed out, a medical device licence provides authorization to sell medical devices. This requires compliance with the appropriate parts of section 32 of the Regulations depending upon the classification of the medical device and allows you to place the product on the market. Now that it ...

RE: Health Canada medical device clinical trial inspection

Posted By Don Boyer 18-Jun-2019 06:02
Found In Egroup: Regulatory Open Forum \ view thread
Hi Karen, The design, conduct, recording and reporting of clinical investigations carried out in human subjects (i.e. ISO 14155) is assessed at the time of applying for Investigational Testing Authorization (ITA) by the Medical Devices Bureau and not during an inspection. Health Canada inspections, ...