Final Record of Decisions May 24, 2018 Meeting: Canada’s Medical Technology Companies (MEDEC)
Health Canada - Health Products and Food Branch (HPFB)
Bilateral Meeting Program
1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario
May 24, 2018
(1:00 p.m. to 3:40 p.m.)
Brian Lewis, President & CEO, MEDEC
Diana Johnson, Vice President, Regulatory Affairs, MEDEC
Greg Leblanc, Cook Medical
Charles Tam, Edwards LifeSciences
Kelly Makimoto, SciCan
Sally Prawdzik, Johnson & Johnson Medical Companies
Stefan Feix, GE Healthcare
Rochelle Gordon, LivaNova
Meghal Khakhar, Baylis Medical
Nancy Abbey, NewProspex Healthcare Consulting
Young Kim, Johnson & Johnson Medical
Health Canada Participants
John Patrick Stewart, Therapeutic Products Directorate (TPD), Co-Chair
David Boudreau, Medical Devices Bureau (MDB), TPD
Rebecca Bose, Marketed Health Products Directorate (MHPD)
Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
Michèle Chadwick, Biologics and Genetic Therapies Directorate (BGTD)
Sarah Chandler, MDB, TPD
Mandy Collier, OPPRS, TPD
Catherine Dion, MDB, TPD
Patrick Fandja, MDB, TPD
Colin Foster, MDB, TPD
Émile Geoffroy, OPPRS, TPD
Frédéric Hamelin, MDB, TPD
John Helmkay, MDB, TPD
Amanda Jones, MDB, TPD
Marc Lamoureux, MDB, TPD
Richard McAteer, MHPD
Ruth Rancy, Regulatory Operations and Regions Branch (RORB)
Jennifer Reid, OPPRS, TPD
Nellie Roest, RORB (by teleconference)
Matthew Ryan, RORB
Nancy Shadeed, Bureau of Policy, Science and International Programs (BPSIP), TPD
Kathy Soltys, MHPD
Donna Watt, OPPRS, TPD
Nicole Charron, Office of Pharmaceuticals Management Strategies, Strategic Policy Branch
- Welcome and Introductions
John Patrick Stewart, Director General of the Therapeutic Products Directorate (TPD), welcomed everyone and thanked MEDEC representatives for making the effort to participate in the meeting face to face. Pat Stewart also thanked MEDEC members for providing valuable feedback on the many recent and important consultations in the branch and the department. A roundtable of introductions followed. Pat Stewart indicated that it continues to be an active time in TPD with a high number of key ministerial and branch priorities underway, including: Regulatory Review for Drugs and Devices; the Cost Recovery Renewal Initiative; and the transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to the Medical Device Single Audit Program (MDSAP). TPD looks forward to holding more information sessions as needed to delve in greater detail on some of these initiatives.
One major organisational change since the last bilateral meeting is that David Boudreau was appointed Director of the Medical Devices Bureau in January 2018. Rhonda Kropp is the new Director General of the Marketed Health Products Directorate.
Brian Lewis, MEDEC Co-chair, introduced Diana Johnson as the association’s new Vice President of Regulatory Affairs. MEDEC indicated that it appreciates Health Canada’s engagement, transparency and conversation. The association noted that it met with Simon Kennedy, the Deputy Minister of Health Canada and had a discussion about engagement and flexibility. MEDEC congratulated the Medical Device Bureau (MDB)’s Medical Device Single Audit Program (MDSAP) team for its work during the transition period. MEDEC indicated that it appreciated the meeting that was held with MDB the morning of May 24, 2018 and that it is always open to engagement.
Review of Agenda
There were no changes to the agenda.
Approval of Meeting Notes / Action Items of the November 2, 2017 Meeting
The minutes of the previous meeting on November 2, 2017 meeting were approved. The action items from the previous meeting were either completed, discussed at this meeting or to be discussed at the next meeting. An update on the Regulatory Enrolment Process (REP) will be provided at the next bilateral meeting on November 8, 2018.
Regulatory Review of Drugs and Devices (R2D2) Update
David Boudreau, Executive Director, MDB introduced the R2D2 team. Michèle Chadwick is the senior advisor for the Regulatory Review of Drugs and Devices Initiative, Biologics and Genetic Therapies Directorate. Colin Foster is the lead for the Device Advice initiative and Marc Lamoureux is the A/Manager of the new Digital Health Division of MDB. MDB indicated that it will engage stakeholders more in the future to obtain feedback on medical device products (guidance documents, notices, etc.).
Update on “Device Advice”
As part of the Regulatory Review of Drugs and Devices project, the Medical Devices Bureau is working on a “Device Advice” initiative that aims to enhance the way in which regulatory requirements and expectations are communicated to stakeholders. The Device Advice initiative consists of:
- an interactive e-Learning course intended to help stakeholders understand Health Canada’s device licensing requirements.
- the development of a formal meeting framework that will allow stakeholders to receive advice and guidance with regards to their clinical investigation plans.
The e-learning course will be published and accessible. It will be a one-stop shop for Guidance Documents and other medical device information. Once the English version is published, MDB will be looking to engage with MEDEC and other targeted stakeholders for feedback.
MDB is in the process of setting the groundwork for a pre-clinical meeting framework and will seek MEDEC’s participation in a future pilot project. MEDEC requested information on whether the guidance also has to change with the Investigational Testing Authorization (ITA). MDB responded that the ITA guidance document will soon be published, and that the pre-clinical meeting framework is not part of the scope of this guidance. Another guidance document on pre-clinical and pre-submission meetings will be developed. MDB is in the process of developing a Working Group on the topic. It is anticipated that the pilot will be ready in December 2018.
Update on the Digital Health Division
The Regulatory Review of Drugs and Devices initiative aims to enhance the Canadian regulatory system by enabling it to be more responsive to health care system needs such as home care and access to innovation. On March 28, 2018, the Medical Devices Bureau formally established a new Digital Health Division. The new division is now responsible for reviewing software; diagnostic, therapeutic, and cosmetic radiation devices; and will be undertaking newer digital health initiatives such as cybersecurity, artificial intelligence, 3D printing, and mobile apps among others.
Three priorities will guide the new division:
- Build a workforce of reviewers in the digital health field, including engineers
- Develop work tools and guidance documents
- Engage with stakeholders to better understand trends and needs, and identify areas of collaboration
MDB is developing a Guidance Document on Software as Medical Device (SaMD). The new Digital Health division will also lead the development of two more documents this year, including one on cybersecurity and one on 3D printing, both planned before the end of the fiscal year. A Scientific Advisory Committee for Digital Health Technologies is being established. It is anticipated that a Call for Nominations for medical device as well as cybersecurity experts will be posted on the Health Canada website during the week of May 28, 2018. Some MEDEC members have already shown interest. MEDEC members are encouraged to apply and to recommend experts. The R2D2 website is updated on a monthly basis.
MDB / MHPD/ RORB Performance Reporting
John Helmkay, Senior Business Process Officer, MDB, TPD, Ruth Rancy, A/Director, Medical Devices Compliance Program, Regulatory Operations and Regions Branch (RORB), and Richard McAteer, A/Manager, Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate (MHPD) provided a presentation to MEDEC and encouraged a discussion related to performance reporting. The Medical Devices Program Performance Report for the fourth quarter of fiscal year 2017-18 included information on licences and authorizations, screening time against the 15 day target, volume of screening deficiencies, time to first decision, volume of additional information requests, time for second decisions, and market authorization time. Statistics for the Regulatory Operations and Regions Branch and the Marketed Health Products Directorate were also provided. MDB noted that in the future, the way that the calculations are done will change.
Performance Improvement Plan
David Boudreau, Executive Director, Medical Devices Bureau, provided a Performance Improvement Placemat that MDB has developed in order to prepare for the new cost recovery regime. It is MDB’s goal to be in a position to process 100% of its applications within the established service standard targets by April 1, 2019. To meet this objective, MDB has developed a list of activities to streamline processes and improve on service delivery. MDB indicated that MEDEC should expect to receive a communication on Investigational Testing Authorization (ITA) improvements by the end of June 2018.
MDB noted that the fax-back process was intended to be simple. Further clarifications will be provided as to the types of applications that will be refused before screening. In the future, all the sections of the form will need to be completed in order to be accepted. The goal is to use the new calculation for screening deficiency. These targets are built on 90% of decisions on time.
Action: Colin Foster, MDB, to provide the rejection criteria regarding fax-backs to MEDEC. Completed: The rejection criteria regarding fax-backs was provided to MEDEC on July 23, 2018.
Update from Investigational Testing Authorization (ITA) Guidance Consultation and November 2, 2017 Meeting on ITA Process Improvements
MEDEC indicated that it was pleased to have the opportunity to provide comments on the Guidance Document - Applications for Medical Device Investigational Testing Authorizations. The association provided a number of comments relating to the topics below. Amanda Jones, Medical Devices Bureau, addressed this item:
Whether there is a need for Research Ethics Board (REB) approvals to be included in ITAs
MEDEC had raised this topic at the November 2, 2017 bilateral meeting. MDB is working in collaboration with the Bureau of Policy, Science and International Programs (BPSIP) to develop a proposal to amend the Medical Devices Regulations to allow for manufacturers to receive investigational testing authorizations (ITAs) prior to obtaining written approval from REBs. The proposed amendments to the regulations would streamline the ITA process and allow for more timely access to investigational testing devices. This can be accomplished through policy change. It is anticipated that the proposed regulatory changes will be published in the Canada Gazette (CG1) in Spring 2019. If this target is met, these changes would then come into effect in Spring 2020. MEDEC indicated that it is pleased that this issue is being addressed.
Flexibility for submission of ITAs for investigator-initiated studies
Health Canada notes that there are regulatory limitations with regards to MEDEC’s request for investigator-initiated trials (i.e. legal responsibility lies with the manufacturer for the medical device and Health Canada regulates the manufacturer, not institutions or clinicians). Health Canada currently allows the manufacturer to provide authorization to a third party during the submission process so that the clinician can, for example, correspond with Health Canada during the review.
ITAs not required for studies where there is no impact to patient care and low risk to study subjects: Health Canada indicated that an ITA is not required where there is no involvement of human subjects. Health Canada added that “low risk” would need to be defined and would likely be a challenge. TPD is open to further discussions on the matter and would welcome specific examples and a supporting rationale where MEDEC believes this would be an option.
Revisions to ITAs
Heath Canada would welcome additional information from MEDEC on this proposal, especially concerning MEDEC’s definition of “subsequent ITAs”. MDB indicated that as the Guidance Document will require a policy change instead of a regulatory change, it should move forward quickly. For the change to the investigative site, MDB is looking at creating a revision form to be submitted rather than going through the whole revision process. This would be more like a notification process for simple changes. MEDEC supported this change. It is anticipated that the revisions to the ITA Guidance Document (non-in vitro diagnostic device (IVD)) will be completed by the end of August 2018. MEDEC indicated that this is a positive sign for future improvements to the process and looks forward to continued engagement with respect to the comments and recommendations on the draft document.
Global Medical Device Nomenclature (GMDN)
Colin Foster, Head, Regulatory and Scientific Section, Medical Devices Bureau presented this item. Health Canada has initiated the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), in order to improve the availability, access to, and the quality of information available on medical devices in Canada. The GMDN is an identification tool that is used worldwide by several medical device regulators. It is a list of generic names used to identify medical device products, allowing for efficient and timely information exchange between jurisdictions and effective monitoring by regulators.
Health Canada is trying to discourage the creation of yet another nomenclature. MEDEC noted that it would be a good idea to try and avoid country specific data pools. A MEDEC member noted that she needs to manage three different medical device codes.
Health Canada has provided manufacturers with a list of their medical devices associated with active medical device licences. Manufacturers have been invited to determine the GMDN code for each of their devices. Health Canada provides support on request. The department is also updating the medical device licence application and licence amendment forms. Once these forms are available, applicants will be asked to provide the GMDN data as part of all new applications and licence amendment applications. It is anticipated that the forms will be available in Fall 2018.
The “Notice: Improving access to medical devices information - Health Canada is adopting the Global Device Nomenclature (GMDN)” has been posted on the Health Canada website.
Update on the Medical Device Single Audit Program (MDSAP)
MEDEC requested an update on the MDSAP program. Frédéric Hamelin, Manager, Quality Systems, Medical Devices Bureau addressed this item. Health Canada has been actively engaging with MEDEC and the medical device industry to support its transition to the new MDSAP program by January 1st, 2019. With a view to alleviate the challenges faced by manufacturers in this transition, the following two measures have been implemented:
- the reduction of the duration of audits for small and medium-sized enterprises (SMEs) meeting certain conditions; and,
- allowing manufacturers to transition to MDSAP while carrying-on with their existing certification cycle under the Canadian Medical Devices Conformity Assessment System (CMDCAS).
Approximately 1,500 facilities have had audits registered with the MDSAP Consortium as of mid-April. This means that they have either undergone an MDSAP audit or will do so in the near future. Over 1,000 audits have already taken place. Based on survey efforts in December of 2017, Health Canada believes that at least half of manufacturers plan to complete the transition in the second half of 2018. Health Canada has stressed to Auditing Organizations (AOs) that it is important to ensure that manufacturers understand the breakdown of costs. Prices may be higher for various reasons according to how the audit is structured. Most Auditing Organizations do not change their costs for a three year cycle. In the future, the new system will provide live up-to-date information and Health Canada will be notified when an audit has been issued.
MEDEC indicated that it appreciates the amount of work that Health Canada has put into the transition from CMDCAS to MDSAP. Health Canada’s regulatory partners in other jurisdictions are supportive of this initiative. TPD indicated that while other countries are interested in joining MDSAP, it is not possible to add jurisdictions right now. TPD is looking at doing outreach through organizations such as the Pan American Health Organization (PAHO) to include these countries. Brazil has already indicated that MDSAP is its preferred method.
Canada-European Union Comprehensive Economic and Trade Agreement (CETA) Regulatory Cooperation Forum - Request for Stakeholder Comments
The Treasury Board Secretariat posted a notice in February 2018 soliciting stakeholder proposals on potential areas for regulatory cooperation with the European Union (E.U.). MEDEC indicated that it has submitted a proposal and requested an update. Nancy Shadeed, Manager, International Programs, Bureau of Policy, Science and International Programs, TPD addressed this item. Once the stakeholder proposals have been collated by the Treasury Board Secretariat, they will then be forwarded to the applicable Department for assessment. TPD indicated that this particular submission is being led by colleagues in the Resource Management and Operations Directorate. TPD looks forward to learning more about MEDEC’s proposal related to transparency and will consider it carefully.
Discussion on Recall Regulations
MEDEC requested information on Health Canada’s perspective on its proposal for non-safety recalls. The association is also interested in discussing future opportunities to address post-market cybersecurity vulnerability reporting to Health Canada. David Boudreau, Executive Director, MDB, and Marc Lamoureux, A/Manager, Digital Health Division addressed this item. MDB is currently in the process of developing guidance for industry on cybersecurity considerations and will consider the positions of peer regulators. MDB intends to discuss its draft policy position with its Scientific Advisory Committee and will also consult with MEDEC.
Health Canada is in the process of drafting amendments to the recall regulations. Industry will be notified via the Canada Gazette process (Spring 2019) as to when the regulatory amendments are available for comment. A draft guidance will be provided to help interpret the changes. There will be a 75-day consultation period following the Canada Gazette publication. At this time, Health Canada will continue to enforce requirements for manufacturers and importers according to the current Regulations.
MEDEC indicated that industry struggles with the current recall regulations as it relates to cybersecurity patches and appreciates all of the work that is happening with digital health. David Boudreau, MDB, noted that the HPFB stakeholder session on the Treasury Board initiative on Regulatory Review will be held on June 27th. Recall regulations could be a potential topic to include in the feedback at the stakeholder session.
Notice of Intent: Strengthening the Post-market Surveillance and Risk Management of Medical Devices in Canada
The Marketed Health Products Directorate (MHPD) of Health Canada has published a “Notice of Intent: Strengthening the post-market surveillance and risk management of medical devices in Canada”. MEDEC indicated that it would welcome the opportunity to be engaged and provide input during the development of the regulations, prior to pre-publication in Canada Gazette, Part I. Patrick Fandja, Medical Devices Section Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate (MHPD) addressed this item. MHPD indicated that it would welcome the input of MEDEC and other medical device stakeholders. MHPD anticipates having an information session in the early Fall 2018 to discuss the proposed regulations. Formal consultations on the proposed regulations will occur as part of the Canada Gazette process which is anticipated for the spring of 2019. MHPD indicated that it will be drafting a Guidance Document to support the regulations.
Pause the Clock
Michèle Chadwick, Co-Lead, Pause the Clock, Regulatory Review of Drugs and Devices, Biologics and Genetic Therapies Directorate, Sarah Chandler, A/Associate Director, and John Helmkay, Senior Business Process Officer, Medical Devices Bureau presented this item. A pause the clock mechanism is proposed as part of the new penalty model to ensure that Health Canada is only accountable for the time it spends on a particular submission/application. Possible medical device triggers include:
- Combination products - when medical devices timelines apply and the clock is paused pending completion of the drug review. With this trigger, the review clock would pause when the initial review of the device portion of the product results in a positive recommendation but the drug review remains outstanding.
- Linked medical device application reviews - The review clock would pause when the review of one device application is complete except that the review of the additional device application it is linked to remains outstanding (an example: When a Class II License Application is completed (15 day target) while the linked Class III or IV applications (60 or 75 day targets, respectively) are not).
MDB is looking forward to hearing from MEDEC for input on the design of the pause the clock process and for any other potential triggers related to medical devices.
a) Correspondence - MEDEC indicated that there are challenges with applications going to the wrong places. MDB noted that MEDEC members should let MDB know if there are any problems with correspondence.
b) MDB Stakeholder Engagement - Marc Lamoureux, MDB, indicated an upcoming increase in stakeholder engagement. MDB is in the process of working on a stakeholder engagement plan.
c) MHPD Stakeholder Engagement - MHPD indicated that it would be sending a survey to manufacturers, including MEDEC, and key provincial stakeholders. It will be sent to the most recent contact on file.
d) Surplus of Inventory with Old Labelling - MEDEC, requested information on whether Health Canada would consider a policy for the transition period for the surplus of inventory with old labelling. The association member indicated that the company needs to create a separate licence which is very expensive. Young Kim was introduced to Ruth Rancy, Director, Medical Device Compliance, Regulatory Operations and Regions Branch so that the question could be responded to offline.
e) Funding - MEDEC noted that the Medical Devices Bureau has undergone a major overhaul and requested information on how the changes have been funded. TPD responded that funding has come in from various sources: cost recovery, R2D2, the staffing budget, and comprehensive review. TPD also noted that along with the increase in funding comes an increased expectation from stakeholders, industry and Treasury Board for MDB performance.
f) MEDEC Regulatory Workshop 2019 - MEDEC thanked Health Canada for its transparency and for providing an understanding of the cost recovery framework at the recent regulatory convergence workshop. The association is planning next year’s workshop and requested feedback on whether to hold the meeting in Ottawa or Toronto. MDB responded that if the meeting is held in Ottawa, more Health Canada employees would be able to attend but that MDB would still participate if the meeting is to be held in Toronto.
g) Table of Contents (TOC) Notice - David Boudreau, MDB, indicated that a TOC Notice will be posted soon. MDB will be sending out a notice for consultation in mid-June 2018. MDB is exploring a longer transition period for the adoption of the Table of Contents format. MEDEC will have the opportunity to provide feedback during the consultation period. David Boudreau, MDB, noted that he appreciates working with MEDEC and looks forward to further collaboration with the association.
h) Special Access Programme (SAP) Renewal - John Patrick Stewart, Director General, TPD, provided an update on the SAP Renewal Project which supports more timely access to drugs and medical devices. TPD is looking at ways to modernize the system by addressing areas where the program is not being used appropriately. It is an opportunity to determine if another pathway might be more suitable for drugs or for medical devices. While a regulatory amendment will be required for drugs, it will not be necessary for medical devices.
John Patrick Stewart, TPD, and Brian Lewis, MEDEC, thanked the meeting participants. Health Canada indicated that it appreciates MEDEC’s engagement and feedback.
The meeting was adjourned at 3:40 p.m.
November 8, 2018
Original signed by:
John Patrick Stewart
Therapeutic Products Directorate
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