ThadeusJ
Forum Lieutenant
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Greetings all,
I wanted to reach out to Canadian EMS providers to inform them that access to some equipment may decrease throughout the rest of 2018 and 2019 due to changes in Health Canada's regulatory program. The MDSAP program is a well-intentioned auditing program where a third party auditor goes through the quality assurance program of a manufacturer. The MDSAP program is optional in the USA, Brazil, Australia and Japan, but will be mandatory as of January 2019. If you want to sell in Canada, then you have to have the certification.
The issue is that the MDSAP program replaces the previous CMDCAS system that would normally cost a company $3,000 annually. Companies have received estimates between $35,000-50,000 for an annual audit. I have spoken to 4 Canadian distributors that have told me that some of their foreign-based manufacturers are withdrawing from the Canadian Market as a direct result these increased costs. Also, a colleague spoke with a US-based auditing company and they reported that 80% of their foreign manufacturing clients plan on withdrawing from Canada.
Although this directly affects Canadian manufacturers and distributors, but when you take into account the services that will be told that the product they currently use will no longer be available as well as the impact on patient care, these changes are significant to Canadian healthcare.
This message is to inform EMS services in Canada of what is currently taking effect. If you require additional information, it can be found through a Google search ("MDSAP") or you can contact me directly.
I wanted to reach out to Canadian EMS providers to inform them that access to some equipment may decrease throughout the rest of 2018 and 2019 due to changes in Health Canada's regulatory program. The MDSAP program is a well-intentioned auditing program where a third party auditor goes through the quality assurance program of a manufacturer. The MDSAP program is optional in the USA, Brazil, Australia and Japan, but will be mandatory as of January 2019. If you want to sell in Canada, then you have to have the certification.
The issue is that the MDSAP program replaces the previous CMDCAS system that would normally cost a company $3,000 annually. Companies have received estimates between $35,000-50,000 for an annual audit. I have spoken to 4 Canadian distributors that have told me that some of their foreign-based manufacturers are withdrawing from the Canadian Market as a direct result these increased costs. Also, a colleague spoke with a US-based auditing company and they reported that 80% of their foreign manufacturing clients plan on withdrawing from Canada.
Although this directly affects Canadian manufacturers and distributors, but when you take into account the services that will be told that the product they currently use will no longer be available as well as the impact on patient care, these changes are significant to Canadian healthcare.
This message is to inform EMS services in Canada of what is currently taking effect. If you require additional information, it can be found through a Google search ("MDSAP") or you can contact me directly.