Our recent insight post highlighted a key change in Health Canada’s requirements for companies seeking authorisation to market their devices. A change that is leading to disquiet amongst manufacturers for the Canadian market.
From 1 January 2019, Health Canada will only accept manufacturer audits performed under the MDSAP programme, closing the current conformity assessment system. Manufacturers are not expected to make the switch overnight, however. Health Canada published specific criteria in April, for manufacturers to preserve their current ISO 13485 certification and surveillance cycles whilst transitioning to the new arrangements.
Perhaps understandably, the change is causing consternation to manufacturers of smaller volume medical devices. Companies are reporting a ten-fold increase in audit costs as a result of the change, an increase that is likely to hit small businesses hardest, according to a recent report by Canadian national newspaper The Globe and Mail.
Whilst having a successful MDSAP audit would aid registration in other territories, the way MDSAP audits are performed may result in a more lengthy and costly process for Canadian manufacturers. The scarcity of resources to perform the audits, and the passage of time, may exacerbate the situation.
It should be noted that the regulatory requirements remain the same in 2019, it is the method for confirming compliance that will change. Health Canada expect adopting the MDSAP requirement will “strengthen the post-market surveillance and risk management” for medical devices.
The Globe and Mail reports Health Canada as “offering to reduce, for small companies, the time spent performing the audit” alongside giving more time to have the audit completed, as long as its scheduling is done in 2018.
It has been said that the change could bring advantages to manufacturers in the EU and US looking to market their devices in Canada – as having a successful MDSAP audit stands them in good stead for registration in multiple countries. Closure of the Canadian conformity assessment system removes a hurdle for those companies, reducing the “cost of entry” somewhat.
This situation underlines the long-term benefits of considering regulatory requirements for a range of territories when developing medical devices, instead of focusing in on requirements of the launch market.
Only time will reveal the true impact of the change, on both domestic Canadian medical device manufacturers and those looking at entry into the country’s health care market. We will keep you posted on developments.