The future is now!
As announced for the first time by Health Canada in April 2016, the 1 January 2019 marked the official date that the country replaced its CMDCAS program with MDSAP!
This means that manufacturers who do not hold a valid MDSAP certificate or are not currently in transition to MDSAP will see their medical device licenses suspended, effectively denying them access to the Canadian market.
Canada has therefore become the first country to implement MDSAP as the sole mechanism for manufacturers to introduce new medical devices to its market. At the same time, Health Canada has made adjustments to this process to assist businesses in making a smooth transition from CMDCAS to MDSAP and to reduce the regulatory burden on the medical device industry. Together these actions demonstrate the country’s clear commitment to improving patient safety and the effectiveness and quality of its medical devices.
In fact, Canada has already announced that it will not stop here with its plans to improve and innovate this sector. In December 2018, Health Canada published the Action Plan for medical devices that will begin in early 2019 and identifies the strategy for their goal:
“Despite the strong foundation of Canada’s existing Regulations, more can be done to improve the safety and effectiveness of medical devices and to optimize health outcomes for patients. This Action Plan lays out a three-part strategy, which will be achieved through improving how devices get on the market; strengthening monitoring and follow-up of devices once they are being used by Canadians; and providing more information to Canadians about the medical devices they use. Collaboration with provinces and territories, and other health care system partners will be fundamental to delivering results. Health Canada will strengthen and expand existing outreach and information activities, as appropriate, to reinforce these important partnerships.
Health Canada will promote open communication and engagement with Canadians throughout the implementation of the Action Plan to ensure that all perspectives, particularly those of the people who use medical devices, are taken into account when developing policies and regulations. It will also keep Canadians up to date with progress on the Action Plan so that they know what the Department is doing to enhance the safety and effectiveness of the devices they use.”
On the other side of the Atlantic, Europe is also making the transition towards safer and more effective medical devices by introducing the new regulations MDR and IVDR.
The harmonization and market momentum brought about by the introduction of MDSAP in Canada and MDR/IVDR in Europe will make 2019 a groundbreaking year for the medical devices industry and its suppliers.
Here is where The Tao of Excellence can be of significant assistance. Whether you are a recent start up in the industry or a larger and experienced company, The Tao of Excellence has the expertise, logistical support and structures in place to ensure the smooth, efficient and effective compliance to MDSAP at all levels. Contact us today for more information and to ensure your company is well-prepared for business and its future!
Denis Vörös
Phone
+41 52 685 51 65
Email
[email protected]
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