Final Record of Decisions - June 1, 2017, Meeting with Canada’s Medical Device 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

June 1, 2017
(1:00 p.m. to 3:50 p.m.)

MEDEC Participants

• Brian Lewis, MEDEC
• Stefan Feix, GE Healthcare
• Seema Vyas, Medtronic Canada
• Charles Tam, Edwards Lifesciences
• Melissa Lake, Philips Healthcare
• Rochelle Gordon, Livanova
• Danna Zylka, ConMed
• Linda Lindsay, Baxter
• Sally Prawdzik, Lifescan
• Kelly Makimoto, SciCan
• Enoch Owusu, Zimmer Biomet
• Diana Johnson, Alcon Canada
• Young Kim, Johnson & Johnson Medical

Health Canada Participants

• Marion Law, Therapeutic Products Directorate (TPD), Co-Chair
• Kimby Barton, Director General's Office, TPD
• Carey Agnew, Medical Devices Bureau (MDB), TPD
• Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
• Michèle Chadwick, Biologics and Genetic Therapies Directorate (BGTD)
• Sarah Chandler, MDB, TPD
• Anik Michelle Chartrand, Regulatory Operations and Regions Branch (RORB)
• Mandy Collier, OPPRS, TPD
• Kevin Day, MDB, TPD
• Patrick Fandja, MDB, TPD
• Colin Foster, MDB, TPD
• Debra Haltrecht, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD)
• John Helmkay, MDB, TPD
• Trish Larwill, Resource Management and Operations Directorate (RMOD)
• Christine Lefebvre, MDB, TPD
• Joe-Anne McKittrick, OPPRS, TPD
• Catherine Milley, MDB, TPD
• Mary Raphael, Marketed Health Products Directorate (MHPD)
• Georgette Roy, BGTD
• Matthew Ryan, RORB
• Myriam Sarazin-Frey, MHPD
• Nancy Shadeed, Bureau of Policy, Science and International Programs (BPSIP), TPD
• Colleen Turpin, MHPD
• Douglas Watson, BPSIP, TPD
• Donna Watt, OPPRS, TPD

Observers

• Nicole Charron, Office of Pharmaceuticals Management Strategies, Strategic Policy Branch

1. Welcome and introductions

Marion Law, Director General, Therapeutic Products Directorate (TPD), welcomed participants to the meeting. She shared some thoughts about Klaus Stitz, MEDEC, and sent TPD's warmest regards.

For organizational changes, Kendal Weber is now A/Associate Deputy Minister of the Health Products and Food Branch. Kathy Soltys is the Director of TPD's new Bureau of Medical Sciences that was created on January 1, 2017. The Bureau's mandate is to provide medical review expertise, guidance, and the Canadian medical practice context to the regulation of pharmaceutical drugs. An update was provided from the Regulatory Operations and Regions Branch that Matthew Ryan is now manager of the Medical Devices Compliance and Licence Unit.

Brian Lewis, MEDEC Co-chair, indicated that the International Medical Device Regulators Forum (IMDRF) that was held March 14-16, 2017 in Vancouver was a good meeting. He appreciated Health Canada's willingness to build meaningful dialogue and congratulated Nancy Shadeed, Bureau of Policy, Science and International Programs, TPD for her team's role. MEDEC indicated that it is looking forward to September and that there is a lot of work to do in terms of adopting innovation. MEDEC has been having conversations on the procurement process, engagement of training and updates of physicians. There have been discussions on how to bring more people into the conversations.

2. Review of agenda

There were no changes to the agenda.

3. Approval of meeting notes / action items of the November 1, 2016 meeting

The minutes of the November 1, 2016 meeting were approved. For Action Item 6 - Use of FDA Guidance to Support Canadian Medical Device Licence Applications: MDB to work with MEDEC to set up a small group of people to put together a workplan to pinpoint areas of focus for scientific advice meetings, documents or webinars.

Action: MEDEC to contact the Director's Office, MDB (Francoise.Cain@canada.ca) to set up this meeting.

The other action items were completed.

4. Improving access and use of necessary therapeutic products

Michèle Chadwick, Biologics and Genetic Therapies Directorate, provided an overview of the work underway on the regulatory review of drugs and devices initiative where the goal is to improve access to necessary therapeutic products that meet a health care system need. This initiative is a clear government priority as part of the commitment to work with provinces and territories in the development of a new Health Accord that was outlined in the Health Minister's Mandate Letter.

Specifically, there is a focus on key priority areas where change would yield the biggest results. One of those areas is improved access to necessary prescription medications. Budget 2017 also earmarked support for this initiative.

Key areas of focus for the Health Products and Food Branch include:

• Health care system collaboration and international engagement
• Timely and appropriate access to therapeutic products
• Real-world evidence throughout the product lifecycle, and
• Modernized cost recovery and business systems.

Projects under each of these areas of focus include:

Health care system collaboration and international engagement

• Aligning regulatory and health technology assessments
• Providing early advice by Health Canada and health technology assessors
• Enhanced use of foreign reviews to encourage submission filing for products that would not otherwise be available for sale in Canada
• Sharing workload with international regulatory counterparts with regulatory colleagues

Timely access to therapeutic products

• Expanding priority review pathways for drugs that meet health care system needs
• Enhancing reviews of generic drugs, medical devices and biosimilars
• Improving reviews of digital health technologies
• Modernization of the Special Access Programme (SAP)

Enhanced use of real-world evidence

• Using more real-world safety and effectiveness data for drugs and devices across a product's life cycle

Modern and flexible operations

• A robust and agile cost recovery regime
• Modernized business systems-a common submission intake system
• Sharing of data that is not considered confidential business information

Health Canada is interested in receiving feedback from MEDEC regarding all of these projects.

Trish Larwill advised MEDEC that Health Canada will be renewing existing cost recovery fees. A proposal for User Fees and Service Standards for Human Drugs and Medical Devices Programs (User Fees Proposal) will go out for consultation in Summer 2017. Health Canada anticipates implementing the fees in 2018 and will include this in the consultation process. A workshop with stakeholders will be held in July 2017. The consultation document will be released before the workshop takes place. Questions regarding this initiative should be referred to Trish Larwill.

5. Pre-submission meeting process

Joe-Anne McKittrick, Office of Planning, Performance and Review Services, TPD informed MEDEC of TPD's improvement action plan (IAP) for the pre-submission meeting process for medical devices established in response to an internal quality audit conducted in 2015-2016. One of the key deliverables of the IAP is the development of a framework that would outline objectives, expected outcomes and criteria for pre-submission meetings that address stakeholder needs.

TPD requested MEDEC's advice for ways to collaborate with the association's members about the pre-submission meeting process. TPD is seeking mechanisms to engage stakeholders in determining their needs, objectives and expected outcomes of pre-submission meetings. Young Kim, MEDEC, indicated that she would share this request with association members.

6. Medical Devices Bureau (MDB)/Marketed Health Products Directorate (MHPD)/Regulatory Operations and Regions Branch (RORB) performance reporting

John Helmkay, Senior Business Process Officer, MDB, TPD; Mary Raphael, Associate Director, Marketed Health Products Safety and Effectiveness Information Bureau, MHPD; Patrick Fandja, Manager, Marketed Pharmaceuticals and Medical Devices Bureau, MHPD; Anik Michelle Chartrand, Director, Medical Devices Compliance Program, RORB; and Matthew Ryan, Manager, Medical Devices Compliance and Licensing Unit, RORB 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 2016-17 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, evaluation backlog and market authorization time. Statistics for the Marketed Health Products Directorate and the Regulatory Operations and Regions Branch were also provided.

7. Licence application quality

MEDEC provided an overview of the activities it has undertaken with the object of improving licence application quality. Catherine Milley, Senior Evaluator, Cardiovascular Device Evaluation Division, Medical Device Bureau, TPD addressed this item. MDB implemented a "Quality Report Card" in 2014, in order to provide feedback to medical device licence applicants on submission quality (namely organisation, consistency, completeness, clarity, and ease of review). The overall aim of this effort was to aid applicants in determining where poor submission quality might have hindered the technical review, with the hope that the feedback could be used to improve the quality of future submissions. There has been some analysis of the scores of these report cards over time, without clear improvements in quality. There are a number of variables which are likely involved, including low frequency of "same-company" applications, movement to electronic only submissions, as well as individual variability in scoring.

MDB is now considering next steps for the Quality Report Card (QRC) project, which might focus more on identifying manufacturers that provide poor quality submissions and which might target communication of results to a manufacturer's upper management. MDB would like feedback from MEDEC members on their experience with the current information provided in the Quality Report Cards so that MDB can better identify which positive aspects of the current process might be saved, and which elements that have less direct impact on improving submission quality can be eliminated.

MEDEC indicated that the Quality Report Cards seem to be very general and while the quality is fair to good, they do not provide enough granularity. The association indicated that not all companies received a report card and that there is a lack of consistency. MEDEC noted that Health Canada would need to invest more resources in order to provide the level of detail required by companies.

MEDEC members were asked to provide any more feedback they may have on the Quality Report Cards to Greg Leblanc, MEDEC.

8. Quality initiatives for mandatory problem reports

Colleen Turpin and Myriam Sarazin-Frey, both of the Marketed Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate (MHPD), presented this item. They outlined new quality initiatives that are coming from the Marketed Health Products Safety and Effectiveness Information Bureau in regards to the Mandatory Problem Reports received. MEDEC requested that MHPD share its findings on where industry needs training. MEDEC expressed concern on how to ensure that communications from MHPD are received by the right person. A future discussion will be held on the topic.

MHPD requested feedback from MEDEC on the new quality initiatives and the association indicated that the process sounds good. MHPD noted that a focus group may be held and that templates can be sent out to stakeholders. MEDEC appreciated the collaboration that MHPD provided to the association in relation to the project.

Action: Colleen Turpin, Marketed Health Products Directorate to share information with MEDEC on what the regulatory contacts should be and where industry needs training in relation to Mandatory Problem Reports.

Update: Action completed. Health Canada has been in contact with Sally Prawdzik, MEDEC.

9. Special Access Programme (SAP)/ Investigational Testing Authorization (ITA) administration, process & review

MEDEC indicated that its members have noticed an increase in the number of SAP authorizations that require amendments due to processing difficulties. Christine Lefebvre, Regulatory Affairs Supervisor, MDB addressed this item. TPD indicated that the Special Access Unit has not experienced a significant increase in the number of authorizations requiring amendments. In 2014, 2.5% of all applications resulted in an amendment letter, in 2015, 2.78%, in 2016 3.2% and in 2017, 2.6%. These numbers have been relatively consistent over the years.

MEDEC also noted that since the switch to electronic submissions for Investigational Testing Authorizations (ITAs), the applications seem to take longer than in the past. TPD responded that on January 3, 2017 the option for electronic-only submissions was introduced. At that time, fewer than 30% of the applications received were solely electronic. As of April 1, 2017 all submissions were expected to be fully electronic. The learning curve associated with the transition to an electronic process for file submission and processing may be causing short term delays. Timelines are expected to get back on track to the 30 day target.

If any MEDEC members are experiencing a significant increase in SAP authorizations that require amendments or are having any challenges with ITAs, please contact Bisi.Lawuyi@canada.ca.

10. Commercial reprocessing of single use medical devices - licencing

On February 2015, Health Canada released a notice about its intention to require commercial reprocessors of single use devices to be held to the same requirements as manufacturers of new devices. The transition deadline had been extended to September 1, 2017. MEDEC requested an update on this activity. Sarah Chandler, Manager, Device Licensing Services Division and Kevin Day, Manager, Cardiovascular Device Evaluation Division, MDB, addressed this item. To date, MDB has issued 15 Class II and 1 Class IV licences for reprocessed single use medical devices. At this time, MDB intends to continue reviewing new Class II reprocessed single-use device (rSUD) medical device licence applications.

11. Reclassification of high level disinfectants

MEDEC members requested an update on the policy notification regarding the reclassification of high level disinfectants. Nancy Shadeed, Manager and Doug Watson, Senior Policy Analyst, both of the Bureau of Policy, Science and International Planning, TPD addressed this item. TPD is planning to publish the final notice on the reclassification of device disinfectants and sterilants in Fall 2017. Updated guidances will also be made available at that time, to provide information on transitioning marketed products as well as new licensing processes/requirements. Full implementation is anticipated for 12 months afterward, in Fall 2018. A proposed timeline for the reclassification of disinfectant devices was provided to MEDEC.

12. Regulatory amendments

MEDEC requested an update on the timelines for Canada Gazette publication of device recall amendments that were proposed in the June 2016 Notice of Intent. Debra Haltrecht, Manager, Policy Development, Office of Legislative and Regulatory Modernization, Policy Planning and International Affairs Directorate addressed this item. Health Canada is working toward a Fall 2017 timeframe for Canada Gazette, Part I publication of the Recall of Therapeutic Products regulatory proposal. Health Canada continues to consider and assess an appropriate risk-based threshold for reporting the voluntary recall of a medical device, where only recalls undertaken to mitigate a risk of injury to health would need to be reported (but records of all recalls would have to be maintained including justification for any recall not reported), for inclusion in the context of the recall regulatory proposal.

MEDEC also requested an update on the timeline for any other regulatory changes as a result of Vanessa's Law. TPD indicated that on April 22, 2017, Health Canada announced the publication of proposed Regulations Amending the Food and Drug Regulations (Vanessa's Law) in Canada Gazette, Part I. Health Canada is working toward a Fall 2017 timeframe for Canada Gazette, Part I publication of draft regulations on public release of clinical information in drug submissions and medical device applications.

Health Canada continues to develop other regulatory proposals related to authorities granted under Vanessa's Law, including the terms and conditions on market authorizations and mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions.

13. Reporting recall information in both official languages

Anik Michelle Chartrand, Director, Medical Devices and Clinical Compliance, and Matthew Ryan, Manager, Medical Devices Compliance and Licensing Unit, Regulatory Operations and Regions Branch (RORB) presented this item. RORB informed MEDEC and its members about the new request in GUI-0054 that was released last year for recall reporters to provide reasons for recall in both official languages. Health Canada would like to ensure the information it posts on the Healthy Canadians website is accurate in describing the recall and believes manufacturers and their Canadian representatives are best placed to provide accurate information in both English and French. Health Canada would also like to raise awareness for the use of the Medical Device Recall Reporting Form (FRM-0360) which includes both an "Initial Recall Reporting Form" and a "Final Recall Reporting Form".

Matthew Ryan, Regulatory Operations and Regions Branch, to consider adding to the next version of the GUI-0054 that the recall information provided by manufacturers will be posted on the Health Canada website.

14. International Medical Device Regulators Forum (IMDRF) meeting debrief and planning

Nancy Shadeed, Manager, Bureau of Policy, Science and International Planning, TPD indicated that this topic has been discussed with MEDEC earlier in the day. TPD appreciated the support that MEDEC members provided to set up the Session on Cybersecurity at the Open Stakeholders Day for the Vancouver IMDRF Meeting on March 14-16, 2017. TPD is interested in continuing this collaboration for the upcoming meeting in Ottawa on September 20, 2017.

15. Roundtable

Action: MEDEC to provide Carey Agnew, A/Director, MDB, with a list of the association's regulatory committees and their chairs/co-chairs.

Update: Action item completed. The list was provided to MDB on August 1, 2017.

Next Meeting

November 2, 2017

16 Adjournment

Marion Law and Brian Lewis thanked everyone for participating in the meeting.

Meeting adjourned at 3:50 p.m.

Original signed by:

John Patrick Stewart
Director General
Therapeutic Products Directorate