Final Record of Decisions - November 2, 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

November 2, 2017
(1:00 p.m. to 4:00 p.m.)

MEDEC Participants

• Brian Lewis, MEDEC
• Linda Lindsay, Baxter
• Greg Leblanc, Cook Medical
• Rochelle Gordon, Livanova
• Kelly Makimoto, SciCan
• Charles Tam, Edwards Lifesciences
• Dinar Suleman, LifeScan Canada, a division of Johnson & Johnson Inc.
• Monica Magidin, Siemens Healthineers
• Stefan Feix, GE Healthcare
• Sally Prawdzik, Johnson & Johnson
• Diana Johnson, Alcon Canada
• Alan Coley, Coley Consulting

Innovation, Science and Economic Development Canada (ISED) Participants

• Josette Gallant
• Ali Akbari

Health Canada Participants

• John Patrick Stewart, Therapeutic Products Directorate (TPD), Co-Chair
• Celia Lourenco, Director General's Office, TPD
• Carey Agnew, Medical Devices Bureau (MDB), TPD
• Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
• Sarah Chandler, MDB, TPD
• Mandy Collier, OPPRS, TPD
• Kevin Day, MDB, TPD
• Patrick Fandja, MDB, TPD
• Sindy Fernando, Office of Submission and Intellectual Properties (OSIP), TPD
• Colin Foster, MDB, TPD
• Frédéric Hamelin, MDB, TPD
• John Helmkay, MDB, TPD
• Trish Larwill, Resource Management and Operations Directorate (RMOD)
• Bisi Lawuyi, MDB, TPD
• Marc Lamoureux, MDB, TPD
• Richard McAteer, Marketed Health Products Directorate (MHPD)
• Anna McCrum, OPPRS, TPD
• Katerina Paschakis, RMOD (by teleconference)
• Ruth Rancy, Regulatory Operations and Regions Branch (RORB)
• Nellie Roest, RORB (by teleconference)
• Nancy Shadeed, Bureau of Policy, Science and International Programs (BPSIP), TPD
• Douglas Watson, BPSIP, TPD
• Donna Watt, OPPRS, TPD

Observers

• Nicole Charron, Office of Pharmaceuticals Management Strategies, Strategic Policy Branch
• Kelly McClellan, DGO, TPD

1. Welcome and introductions

John Patrick Stewart, the new Director General of TPD, welcomed everyone and thanked the representatives who travel to attend these meetings. TPD values these meetings and considers its work with MEDEC as essential to its operations.

An update on the following organizational changes within TPD was provided. Marion Law left TPD in June 2017 to accept a two-year assignment with the Work Health Organization (WHO) in Geneva. Celia Lourenco is now Senior Executive Director in the Director General's Office and Kimby Barton has moved to the Regulatory Operations and Regions Branch. Carey Agnew is currently acting Director of the Medical Devices Bureau and Sarah Chandler is acting Associate Director.

In terms of recent events of importance for medical devices, Health Canada has now completed its role as Chair of the International Medical Device Regulators Forum (IMDRF) Management Committee. Health Canada hosted its second management meeting in Ottawa September 19-21, 2017, and the event was a reminder of the importance of the Department's work to support convergence initiatives with other regulators.

Brian Lewis, MEDEC co-chair, welcomed John Patrick Stewart into his new role and indicated that the association is pleased to be working with him again. He added that good progress has been made while collaborating together.

2. Review of agenda

There were no changes to the agenda.

3. Approval of meeting notes / action items of the June 1, 2017 meeting

MEDEC indicated that it is interested in revisiting Action Item 3 from the June 1, 2017 record of decisions: Use of United States Food and Drug Administration (FDA) Guidance to Support Canadian Medical Device Licence Applications.

Action: Carey Agnew, MDB to work with MEDEC to set up a small group of people to put together a work plan pinpointing areas of focus for scientific advice meetings, documents or webinars.

The minutes of the June 1, 2017 meeting were approved and all other action items were completed.

4. Spectrum consultation

Josette Gallant, Acting Director, Regulatory Standards, Engineering, Planning & Standards Branch, Innovation, Science & Economic Development (ISED) Canada and Ali Akbari, Manager, Engineering, Planning & Standards Branch, ISED provided an overview of the Spectrum Management Program and introduced Departmental representatives.

Innovation, Science & Economic Development Canada will be publishing a consultation on low-power devices in the 600 MHz frequency band. ISED is seeking to inform stakeholders, including manufacturers and users of wireless medical telemetry devices operating in the 608-614 MHz frequency band, of this public consultation. ISED encourages stakeholders to provide feedback on key questions raised in the consultation.

ISED indicated that engagement with stakeholders on the spectrum regulatory process is becoming increasingly important to keep up with technology development and to ensure the Department is able to support innovation in the healthcare industry. ISED's Spectrum Management consultations can be found at the following link: Spectrum Management.

ISED is interested in having future discussions with stakeholders on the development of wireless medical device technology. In this regard, ISED will be contacting MEDEC in order to understand spectrum needs related to medical devices. Linda Lindsay, MEDEC, noted that it would be a good idea to bring in engineering specialists who are familiar with bandwidth for this conversation. Brian Lewis, MEDEC, indicated that he would help reach out to other companies. Carey Agnew, Medical Devices Bureau, TPD, offered to be a contact for this topic.

5. 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 second 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.

6. Update from the June 1, 2017 meeting on Investigational Testing Authorization (ITA) process improvements

MEDEC members indicated that they are interested in working with Health Canada to find ways to improve the review and approval of first in man studies. MEDEC proposed that the ITA application remove the requirement for full research ethics board approval to be submitted to Health Canada. The association noted that the submission of the informed consent form and evidence that the study in question has been submitted to a qualified Research Ethics Board should be sufficient.

Bisi Lawuyi, Manager, Device Evaluation Division, Medical Device Bureau, TPD addressed this item. The Medical Device Regulations require evidence of Research Ethics Board (REB) approval for Class III and IV devices before an authorization can be granted (section 81 (h)). MDB indicated that conditional approval from the REB, pending Health Canada (HC) authorization, is also acceptable. This does not prohibit sponsors from applying for an ITA while REB approval is pending. TPD indicated that if it is of interest to MEDEC members, an REB submission could be made upon screening acceptance of an ITA. MEDEC indicated that obtaining conditional approval from the REB would be helpful as it would save time. TPD would also be open to implementing other measures to improve the process (e.g., issuing an information notice to REBs in Canada to inform them of this requirement; or upon acceptance of an ITA application for review, issuing a letter for the sponsor to provide the REB as evidence that the application is pending Health Canada's review). The draft of the updated ITA guidance document (planned to be posted this fall) provides further clarification on this issue.

Action: Celia Lourenco, Director General's Office, TPD, to discuss the issue with colleagues.

TPD requested MEDEC's assistance in identifying measures to improve the process. MEDEC members commented that when the opportunity arises to become involved in a global trial that Canada does not have the opportunity to enroll patients. By the time approval is received in Canada, enrollment period has ended. TPD noted that the investigational testing guidance has been revised and will be posted for consultation in the near future. Brian Lewis, MEDEC, offered to provide MDB with specific examples of challenges that MEDEC members have with Investigational Testing Authorizations (ITAs).

MEDEC indicated that within Canadian based organizations that manufacture in Canada it is a challenge to find experts that have the technical skills, particularly those looking to expand manufacturing. There is a need to go outside of Canada to find these experts. MEDEC indicated that it is also working with Ryerson University to ensure that the skill set is available in the future. Health Canada noted that it also has a program in place.

MEDEC requested information as to whether consideration has been given in the ITA guidance document to a discussion about low-risk clinical trials. Health Canada indicated that this issue has been taken into consideration and is currently being discussed.

7. Transition to Medical Device Single Audit Program (MDSAP)

MEDEC requested information on various aspects of the transition to the MDSAP. MEDEC indicated that as MDSAP comes closer to implementation, association members are becoming more concerned about the costs and impact of the extended timetable required to complete the audit. MEDEC is hearing that some companies are not planning to pursue market authorization in Canada. There is also concern about the possibility of some medical devices no longer being available for sale in Canada after January 2019.

Frederic Hamelin, Medical Devices Bureau, TPD provided an update. As of September 11th, 2017, 465 facilities have begun or completed the transition to MDSAP; there are four fully recognized MDSAP Auditing Organizations; there are an additional nine authorized MDSAP Auditing Organizations; and there are over 900 auditors registered to take the mandatory MDSAP on-line training. The biggest obstacle to the deployment of MDSAP continues to be manufacturer uptake. Some Auditing Organizations are concerned that manufacturers are waiting too long to begin the transition and will not be able to complete it in time.

MEDEC expressed concern that smaller companies may find the costs of MDSAP to be higher than those of the larger companies. Health Canada indicated that it is aware of the challenges that MDSAP can present for smaller manufacturers and is working with regulatory partners in the MDSAP Consortium to address these challenges. Health Canada added that there is a lot of misinformation that is circulating amongst companies in regard to the cost of MDSAP. TPD and MEDEC will discuss how to communicate accurate MDSAP cost information to companies.

The prime determinant of overall certification costs is on-site audit time. The MDSAP Consortium has therefore focused its efforts on reducing audit time while maintaining the integrity of the audit and certification process. On October 31, 2017, Health Canada posted a Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times outlining the work that is being done to address the concern of cost. These reductions are expected to adjust MDSAP on-site audit time to within approximately one day of the typical on-site audit time for audits under CMDCAS.

Health Canada does not have the ability to affect the day rate charged for audits and suggested that small manufacturers obtain a few quotes because not everyone charges the same. Health Canada is trying to bring costs in line but there are five regulators involved and the process needs to work for everyone.

Given that manufacturers were given more than three years to complete the transition, Health Canada will not be providing an extension to the January 1, 2019 transition deadline. MDB is currently conducting an analysis and attempting to identify unique or essential devices that could potentially no longer be available in Canada after January 1st, 2019. In early December 2017, MDB will be sending a MDSAP transition survey to companies who will then have approximately three weeks to respond.

MEDEC requested information as to whether there would be enough auditors available. TPD responded that there should be enough auditors as long as all the companies do not request their audits at the same time. Brian Lewis, MEDEC, offered to notify association members that companies should schedule their audits early.

8. Reclassification of high level disinfectants

MEDEC requested an update regarding the activities identified on the proposed timeline for the reclassification of disinfectant devices that was presented at the last bilateral meeting on May 18, 2017. Douglas Watson and Nancy Shadeed of the Bureau of Policy, Science and International Programs, TPD addressed this item. TPD is still targeting Fall 2017 to publish the final notice on the reclassification of device disinfectants and sterilants. After these products are reclassified as medical devices, TPD will seek a regulatory amendment to reclassify them from Class II to Class III devices so that the time and effort required to assess new products is better captured. This would require an amendment to the Medical Devices Regulations. MEDEC expressed concern that products would be reclassified from Class II to Class III devices. Health Canada noted that it is trying to align with international regulators and that there will be a transition period to allow manufacturers to obtain new device licences.

Action: Carey Agnew, MDB, TPD, to share transition plan on the reclassification of high level disinfectants with MEDEC at the end of November 2017.

9. Update/debrief on the Ottawa International Medical Device Regulators Forum (IMDRF) meeting

MEDEC congratulated Health Canada on its involvement in the IMDRF meeting that was held in Ottawa the week of September 18, 2017 and indicated that it believes that it was a success.

Nancy Shadeed, Manager, International Programs Division, Bureau of Policy, Science and International Programs, TPD addressed this item. The Outcome Statement from the IMDRF Meeting in Ottawa has been published on the IMDRF website. The Management Committee approved the new work items on the Unique Device Identification (UDI) Application Guide and the Patient Specific Devices. The Management Committee also announced the closure of two working groups - National Competent Authority Reporting (NCAR) and Software as a Medical Device (SaMD) as the work items have been completed. MEDEC's continued participation in the Regulated Products Submission Working Group and the Standards Working Group will be helpful in moving these work items forward. TPD thanked Sally Prawdik and Dinar Suleman, MEDEC, for helping to find panel speakers for the meeting.

TPD indicated that it is having difficulty with the uptake by companies to apply the Table of Contents (TOC) structure and is requesting assistance from MEDEC in this regard. Health Canada is accepting applications in TOC format as part of a pilot project. TPD has indicated that it will go forward with the revised TOC and is asking for industry's support by using the TOC format.

10. MEDEC 2018 Regulatory Affairs Conference

MEDEC is in the planning stages of the 2018 Regulatory Affairs Conference to be held in Ottawa at the Westin Ottawa on May 15-16, 2018. Carey Agnew, A/Director, Medical Devices Bureau, TPD indicated that the Medical Devices Bureau is supportive of this Conference and will be able to provide speakers to address many of the topics presented. The topics that have been proposed to date appear to be relevant and timely. TPD will continue to work with MEDEC to refine the agenda. TPD is interested in having a panel that follows the lifecycle of a device.

11. Regulatory Enrolment Process (REP) introduction

Katerina Paschakis, Resource Management and Operations Directorate (RMOD) and Sindy Fernando, Office of Submissions and Intellectual Property, TPD presented this item. This Regulatory Enrolment Process (REP) is currently being piloted by Health Canada for product types such as pharmaceuticals and biologics in eCTD format. The intent of the REP is to expand the scope of the Common Electronic Submission Gateway (CESG) to accept non-eCTD electronic-only transactions, including medical devices.

Health Canada is considering Spring 2018 to pilot the REP using the CESG for medical device licence applications. The license application will move to e-format but the actual submission PDF will not change. Under the REP, stakeholders will be able to update their own information. The concept of REP is to automate as much information as possible. Reviewers would therefore receive submissions in a more timely manner. Health Canada will post a Notice about the REP pilot on its website in the near future.

MEDEC indicated its support for this initiative. The association noted that while there are large medical device manufacturers, there are many more small companies. There is a need to give the small companies the same ease of access as for the large manufacturers. Health Canada indicated that it has considered that aspect and is in the process of developing templates.

RMOD indicated that the CESG has released an update designed to improve the user interface and suggested that MEDEC members take a look at the Gateway. Any questions can be sent to the Gateway team's e-review account. MEDEC indicated that it would be willing to assist with finding a small group of companies to pilot the project and provide feedback.

12. Regulatory Review of Drugs and Devices (R2D2) update

Carey Agnew, A/Director, Bisi Lawuyi, Manager, Investigational Testing and Special Access Division, Colin Foster, A/Manager, Device Licensing Services Division, and Marc Lamoureux, Senior Evaluator, General and Restorative Device Evaluation Division, Medical Devices Bureau, TPD, presented an update on the R2D2 initiative. Fifteen projects are underway under four key areas of work (pillars) for this initiative:

1. Expanded Collaboration with Health Partners
2. More Timely Access to Drugs and Devices
3. Enhanced Use of Real-World Evidence
4. Modern and Flexible Operations

The Medical Devices Bureau is leading two projects under pillar 2, "More Timely Access to Drugs and Devices".

Project 1: Building Better Access to Digital Health Technologies

This initiative aims to enhance Health Canada's current regulatory system enabling it to be more responsive to health care system needs such as home care and access to innovation. Specifically, it is anticipated to allow patients and clinicians better access to digital health technologies like wireless medical devices, mobile medical apps, home use health monitoring devices, and medical device software applications which are cutting-edge, have fast innovation cycles, and facilitate remote patient care. A new Radiation Emitting and Digital Health Division has been created within the Medical Devices Bureau, efforts are underway to establish an external Digital Health Scientific Advisory Committee and communications with stakeholders have begun. TPD is looking to MEDEC for any guidance on what is needed so it can support the new technology.

Project 2: Early Pre-Submission Scientific Advice for Medical Devices

The first goal of this project to develop an official meeting process that will allow medical device manufacturers to discuss evidence requirements and clinical trial designs with Health Canada early in the device development process (e.g. during the pre-clinical testing phase) in order to increase submission quality. The second goal of this project is to use tools such as Webinars to convey regulatory educational material to medical device manufacturers and other stakeholders.

TPD is also working on a Special Access Programme (SAP) Renewal project which supports more timely access to drugs and medical devices by addressing current SAP challenges and regulatory gaps. The Directorate is looking at ways to modernize the SAP systems that are used for sending in requests and communicating with clients. More advanced systems will help to increase efficiency internally and facilitate timely responses. John Patrick Stewart, TPD indicated that MEDEC would be added to the list of stakeholders for outreach related to the R2D2 projects.

13. 2017 Health Canada cost recovery changes

MEDEC requested an update on a number of topics relating to Health Canada's proposed changes to cost recovery. MEDEC members generally are in support of increasing Health Canada Medical Device regulatory fees under Cost Recovery provided proportional and defined Health Canada improvement commitments are enabled by the increased fees. Trish Larwill, Manager, Strategic Planning and Accountability Division, Resource Management and Operations Directorate, addressed this item. Health Canada's Fee Proposal for Drugs and Medical Devices (Fee Proposal) is posted on the Health Canada Website and comments can be submitted until January 4, 2018. The Department is aiming to have new fees in place at the beginning of 2019.

Health Canada indicated that there will be a WebEx information session on November 16, 2017. So far, over 500 people have registered for the session. The week of November 6, 2017, Health Canada will hold a sector-specific stakeholder session, to which MEDEC is invited. MEDEC commended Health Canada on its openness and transparency, the breadth of the notices and the fact that Health Canada is willing to have a dialogue on the topic. MEDEC added that it is discussing how to prepare its organization for the new fees.

14. Roundtable

Group on Electronic Regulatory Activities (GERA)

MEDEC requested an update on the list of proposed projects that the Resource Management and Operations Directorate (RMOD) provided at the GERA meeting in September 2017.

Action: Carey Agnew, MDB, TPD, to ask Vikesh Srivastava of RMOD to provide MEDEC with an update on the GERA projects.

15. Adjournment

John Patrick Stewart, TPD, and Brian Lewis, MEDEC, thanked the meeting participants.

The meeting was adjourned at 4:00 p.m.

Next Meeting

May 24, 2018

Original Signed by:

John Patrick Stewart
Director General
Therapeutic Products Directorate