It’s always great to spend time with regulators to understand their point of view on the regulations and guidances they provide to us. It is also helpful to hear about the changes going on at Health Canada to gain insight into their roadmap for the future.
On Thursday, February 27th, 2020, Health Canada’s Sarah Chandler (Director, Bureau of Policy and Operations, Medical Devices Directorate) and Brian Thornton (Senior Expert, Stakeholder Engagement, Medical Devices Directorate) visited Victoria as part of a Stakeholder Outreach program. The session was open to the wider medical device community with attendees from local start-ups, established medical device companies, BC Ministry of Health, the University of Victoria and National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP).
Health Canada is keen to engage with their stakeholders. They’ve taken the feedback that they are difficult to communicate with, and are looking at ways to improve. This visit was to educate attendees and share changes to make working with them easier.
Separate Medical Devices Directorate
Sarah presented the organisational structure for the new Medical Devices Directorate that was put in place mid-January 2020. Medical devices are now being recognised within Health Canada as their own Directorate. At the moment, a number of positions are still vacant but once filled, the team will grow to 165 staff.
The Directorate has been organised with several Bureaus reporting into the Director General:
- Bureau of Evaluation reviews applications for high risk (Class 3 and 4) products;
- Bureau of ITA (Investigational Testing Applications), SAP (Special Access Programme) and Post-Market deals with clinical trials, special access requests and any post-market reporting;
- Bureau of Licencing Services looks after low risk applications, screening checks on all applications (to check the class is correct, correct documents are included and labelling appears correct), administration of licenses, and responses to regulatory questions;
- Bureau of Policy and International Programs is a new team within the Directorate, previously mainly drug-focused, but now with a dedicated medical devices team. International Programs is related to Health Canada’s IMDRF (International Medical Device Regulators Forum) involvement; they are also responsible for domestic policy – including generating guidance documents;
- Bureau of Planning & Operations – the group to which Sarah and Brian belong – will develop an internal ISO 9001 QMS for Health Canada to provide a consistent service to manufacturers. It also contains the Stakeholder Engagement team who is working to improve this service.
It was interesting to note that Health Canada directed and encouraged attending manufacturers to contact relevant positions within the organization when questions were raised.
Another observation is that new structure is more product-focused with groups dedicated to particular product types. The assessors in these groups will have expertise in these product types and can bring in clinical reviewers or other subject matter expert (e.g. human factors) if warranted.
Following a brief refresher on the licencing application process and the product classifications, Sarah updated us on the progress on the Medical Devices Action Plan. In November 2019, a plan was drawn up in response to the media coverage of issues with medical devices. This plan elaborates how Health Canada would improve the safety and availability of medical devices in Canada.
Health Canada’s plan consists of three main points:
- Improve how devices get to market;
- Strengthen monitoring and follow-up;
- Provide more information to Canadians.
Improving how new devices get to market
There was a lengthy discussion about the transition to MDSAP (Medical Devices Single Audit Programme). Health Canada acknowledged it has been a challenge for small businesses with costs and effort being high. However, they are now receiving feedback from people further down the process that it is helping with entering additional markets. The takeaway message was “just hang in there and you will see the benefits”.
Another improvement was the approach, Advanced Therapeutic Products. These are products so new and innovative that there currently is no regulatory pathway for them to follow.
The first product of a new genre will be put into a regulatory “sandbox” where the regulators will work closely with the manufacturers and developers to understand the new product and then determine how it should be regulated. Specifically, this identifies which aspects of the current regulations are actually applicable to the product, and where new regulations or guidances are required. Once an approach has been agreed upon and the product has been shown to comply with it, then it will be released to the market directly by approval by the Director General and the Minister for Health. Regulations would then be updated through full Parliamentary acts for any subsequent products of that genre.
Brian detailed all the effort Health Canada is placing on improving communication, such as training staff on customer services skills, new electronic communication formats, a new website being developed, etc.
Of particular interest is the introduction of “Vendor Days”. These are days when manufacturers can bring new products to Health Canada prior to application, demonstrate them to Health Canada staff, and give Health Canada an opportunity to understand the products in depth. This will aid the application process by having Health Canada staff already familiar with the products and technologies involved. The intention is to hold these events regularly at Health Canada’s offices in Ottawa so that the maximum number of staff can see the products.
The first Vendor day was for orthopaedic and dental implants. It was well received with up to 100 staff attending, including pre-screeners, evaluators, managers and senior managers. The next Vendor Day is planned to be IVD (In Vitro Diagnostics) related, with other discipline to follow. This announcement created a lot of interest among the attendees, though there were concerns about it being based in Eastern Canada without having local options. This suggestion was registered and virtual attendance was mentioned as a possibility, despite lacking a ‘touch and feel’ aspect.
These events are currently promoted by industry associations and government organizations, such as NRC-IRAP. Health Canada recommends adding their site to your RSS feed to find out any upcoming changes. Hopefully the interest flagged in these stakeholder outreach sessions will lead to more communications from Health Canada about these new initiatives. We look forward to hearing more from them as we move forward in this new innovative age.
Helen Simons is a Senior QA/RA at StarFish Medical. Helen has been working in the field of medical device consultancy for over 15 years. She started her career in engineering, progressed through project management of medical device developments to realise a skill in QA & RA problem solving. This is her first StarFish blog.