Final Record of Decisions - November 20, 2015, 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 20, 2015 (1:00 p.m. to 3:30 p.m.)

MEDEC Participants

• Brian Lewis, MEDEC, Co-Chair
• Klaus Stitz, MEDEC
• Monica Magidin, Siemens Canada
• Danna Zylka, ConMed
• La-Toya Salmon, Stryker Canada
• Greg Leblanc, Cook Canada
• Sally Prawdzik, J&J Lifescan
• Meghal Khakhar, Baylis medical
• Young Kim, J&J Medical Canada
• Diana Johnson, Alcon Canada
• Isabelle Gerges, Medtronic/Covidien
• Jessica Danti, Toshiba
• Kelly Makimoto, SciCan
• Marisa Petrielli, Biotronik Canada

Health Canada Participants

• Barbara J. Sabourin, Director General, Therapeutic Products Directorate (TPD), Co-Chair
• Kimby Barton, Senior Executive Director, TPD
• Carey Agnew, Office of Planning, Performance and Review Services (OPPRS), TPD
• Matthew Bown, Marketed Health Products Directorate (MHPD)
• Janet Brunette, OPPRS, TPD
• Mandy Collier, Bureau of Policy, Planning and International Programs (BPSIP), TPD
• Cindy Evans, MDB, TPD
• Patrick Fandja, MHPD
• Colin Foster, MDB, TPD
• Frédéric Hamelin, MDB, TPD
• John Helmkay, MDB, TPD
• Laura Johnson, OPPRS, TPD
• Barry Jones, Office of Pharmaceuticals Management Strategies, Strategic Policy Branch
• Bisi Lawuyi, MDB, TPD
• Rafael Moles, HPFB Inspectorate
• Collin Pinto, HPFBI
• Mary Raphael, MHPD
• Hugh Scheuerman, OPPRS, TPD
• Nancy Shadeed, BPSIP, TPD
• Lisa Wardell, MDB, TPD
• Donna Watt, OPPRS, TPD
• Adam Ziolkowski, MDB, TPD

Health Canada Observers

• Rebecca Bose, BPSIP
• Genevieve Moore, Food and Drugs Act Liaison Office (FDALO)

1. Welcome and Introductions

Barbara J. Sabourin, Director General, Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB) welcomed participants and a roundtable of introductions followed.

Various organizational changes will be taking place within TPD. Barbara J. Sabourin thanked Cindy Evans for having taken on the role of Senior Executive Director, TPD. Cindy Evans will be moving to the Public Health Agency of Canada as Director General, Center for Biosecurity. Kimby Barton is now Senior Executive Director, TPD. Carey Agnew will become Director of the Medical Device Bureau and Lisa Wardell is now Associate Director. Marilena Bassi, who has been on assignment with the Marketed Health Products Directorate will return to her position as Director of the Office of Planning, Performance and Review Services, TPD.

Barbara J. Sabourin will be stepping down as Director General, TPD, and Marion Law will be taking on the role in February 2016. Marion Law is currently Chief Registrar and Director General of the Pest Management Regulatory Agency. Steven Schwendt will become A/Director General of the HPFB Inspectorate.

Barbara J. Sabourin briefly outlined various projects that are underway in TPD and indicated that engagement is likely to continue to be a priority of the new government. If MEDEC has any suggestions of groups that would be beneficial for TPD to reach out to, please send their information to the Director General's Office.

The e-mail system for the Medical Devices Bureau has been converted from Lotus Notes to Microsoft Outlook. As there have been significant issues with obtaining stable e-mail service, MEDEC is encouraged to telephone for any urgent requests. All government e-mail addresses will be changing to a "firstname.lastname@canada.ca" format. Many employees will also be transitioning from telephone landlines to cell phones so they will have new telephone numbers.

Brian Lewis, MEDEC Co-chair, thanked TPD for having the bilateral meeting. He indicated that MEDEC will be working closely with a number of IT and communications companies in order to improve systems and enable better sustainability. Brian Lewis, MEDEC Co-chair, also noted that Alan Edwards, a DFAIT trade commissioner, is working at MEDEC.

2. Review of Agenda

No changes to the agenda.

3. Approval of Meeting Notes / Action Items of the April 20, 2014 Meeting

The minutes of the April 20, 2014 meeting were approved. The action items were either completed or will be added to the agenda for the June 2016 bilateral meeting.

4. MDB/MHPD/HPFBI Performance

John Helmkay, Senior Business Process Officer, Medical Devices Bureau (MDB), TPD, Collin Pinto, Manager, Medical Device Compliance Unit, HPFB Inspectorate and Mary Raphael, Director of the Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate (MHPD), provided a joint presentation. Information covered in the performance reporting presentation included MDB Medical Devices Bureau licences and authorizations; screening times; volume of screening deficiencies; time to first and second decisions; volume of additional information requests; and market authorization time.

Health Canada indicated that when MEDEC company submissions have screening deficiencies, it labour intensive for the Department and for MEDEC member companies. Health Canada noted that only 20% of MEDEC member company submissions go through 'clean', and challenged MEDEC to obtain a rate of 30% 'clean' submissions. MEDEC responded that since companies are competitors, it is difficult to share best practices. However, MEDEC is having a team of member representatives review the situation of screening deficiencies (SDs) and additional information (AI) requests in order to come up with proposals for improvements. The association is considering bringing in a consultant in order to raise the standard.

The Medical Devices Bureau, currently located in Qualicum Towers, will be moving to Tunney's Pasture in Spring 2016. During this time, the Medical Devices Bureau will be unavailable for a couple of days.

5. Transition from Canadian Medical Devices Conformity Assessment System (CMDCAS) to Medical Device Single Audit Program (MDSAP) and Transition to ISO 13485-2016

MEDEC requested information on Health Canada's plans for implementation of the MDSAP program to replace the CMDCAS program. Frédéric Hamelin, Quality Systems Section, Medical Devices Bureau, TPD and Nancy Shadeed, Manager, Bureau of Policy, Science and International Programs, TPD addressed this item. The MDSAP Pilot is scheduled to run until December 31st, 2016. Pending a successful outcome to the pilot, Health Canada intends to implement the MDSAP and transition away from CMDCAS. A date for final implementation of MDSAP will then be established.

During the MDSAP Pilot, recognition is open to all CMDCAS recognized registrars. Manufacturers making use of registrars that are not yet approved by MDSAP should contact their registrar and inquire about their intentions regarding the MDSAP. Manufacturers are encouraged to secure the services of a registrar that can provide services in accordance with their long-term plans. Under MDSAP, manufacturers are required to comply with the regulatory requirements only in participating jurisdictions in which they market their products.

Under MDSAP, Canadian manufacturers that only market their products in Canada will not be required to comply with regulatory requirements beyond the Canadian Medical Devices Regulations. They will however need to replace their Quality Management System (QMS) certificate issued under CMDCAS with one issued under MDSAP by the end of the transition period; this may require that they obtain services from a different registrar.

MEDEC indicated that industry is interested in moving into the MDSAP program. The association would also like to fulfill a promise it made to the FDA to engage more companies in the pilot. MEDEC also requested that small companies be notified about the pilot and the transition to the new system.

Health Canada indicated that the pilot is going well. MEDEC was encouraged to bring more manufacturers into the pilot. Once the transition period is over, they will already be set up in the new system. Health Canada indicated that all CMDCAS Registrars have signaled their intent to apply to be part of the MDSAP pilot and expects that most will be accepted. After the pilot ends, there will be a two-year transition period.

One MEDEC member company indicated that under CMDCAS, companies are audited every year. MEDEC wanted to know how other regulatory authorities in the pilot such as Brazil, United States, Australia and Japan would use the MDSAP audits and the validity of these audits with respect to any Good Manufacturing (GMP) certificates. Health Canada intends to publish a notice addressing the transition from CMDCAS to MDSAP after internal consultations.

6. System Licences

MEDEC requested clarification on the processing of system licences within the Medical Devices Bureau. Colin Foster, A/Head of the Regulatory and Scientific Information Section, Medical Devices Bureau, TPD addressed this item. According to Health Canada's Guidance for the Interpretation of Sections 28 to 31: Licence Application Type document, a medical device system is defined as "a medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device's intended functions and that is sold under a single name". The system itself is regarded as a medical device and section 2.1 of the guidance states that "components of the system must be listed on the licence application by medical device name and identifiers. The application must provide documentation and information on all components of a system."

The Medical Devices Bureau indicated that licensing Class II devices separately from their Class III/IV system poses several challenges to Health Canada. The most efficient way to licence Class III and Class IV devices is to have all products on the same licence. In this way, manufacturers would have fewer licences to renew.

MEDEC asked to be informed when there are small changes in approach in order to avoid receiving screening deficiencies.

Action: Health Canada to provide further clarification about the processing of system licences. Update: System type licences to be addressed at the MEDEC Regulatory Workshop on May 9-11, 2016.

7. 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. This means that commercial reprocessors must meet requirements for licensing, quality system management, labelling, investigating and handling of complaints, maintaining distribution records, conducting recalls, reporting incidents, and informing Health Canada of any changes to the information in their licence application.

By September 1, 2016, all commercially reprocessed devices are expected to be in compliance with the Regulations. MEDEC requested an update on the progress of the transition. Mandy Collier, Associate Director, Bureau of Policy, Science and International Programs, TPD indicated that not many questions have been received on the topic and that Health Canada is willing to keep the lines of communication open.

Health Canada requested information from MEDEC on the level of responsibility of a company to notify hospitals if it knows its devices are being reprocessed. Health Canada has not yet received many applications and expressed concern that there may be a flood of low-quality applications at the end of the period. Health Canada is interested in working towards shared goals with MEDEC. If MEDEC members plan to submit any applications, inform the Medical Devices Bureau.

8. Investigational Testing Authorization (ITA) and ITA Amendment Review

MEDEC requested that Health Canada present performance metrics (average time to authorization) for ITAs and ITA modifications/amendments, if possible with specific view on time to authorize requests to add trial sites to an authorized ITA. Bisi Lawuyi, Manager, Investigational Testing and Special Access, Device Evaluation Division, Medical Devices Bureau, TPD responded that the target timeframes for new ITAs and revised ITAs have not changed. Health Canada is working towards a target of 15 days to complete processing and issuing of a revised ITA for the addition of new investigational sites, provided that all necessary documentation has been submitted.

MEDEC also requested information on the feasibility of adopting a process for the addition of clinical sites similar to Drugs or Natural Health Products for the Clinical Trial Site Information (CTSI) process. Health Canada responded that for Clinical Trials involving Drugs, the Food and Drug Regulations is specifically written with provisions that allow some minor changes to be made to already authorized trials as long a notification is provided within 15 days of the change. The Medical Devices Regulations do not have this provision and specify that the medical device can only be sold to investigators listed on the ITA. To change the process to allow the device to be sold to an additional investigator prior to the issuance of a new ITA would be contrary to the Regulations.

Some other ITA modifications that Health Canada receives, such as device modifications or technical /scientific revisions to the protocol, may need to undergo scientific review, and instead will fall within the anticipated 30 day target timeframe.

Recently, review times for the new ITA applications have increased. This is due to the fact that many are for novel and complex cardiovascular devices that require significant time to complete review, such as drug coated balloons or stents, life-sustaining devices, or devices for which there are no licensed comparators.

9. Electronic Forms for Medical Device Reporting

Mary Raphael, Associate Director, Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate and Collin Pinto, A/Manager, Medical Device Compliance Unit, HPFB Inspectorate provided a joint presentation. In order to streamline the submission and intake of reports, Health Canada will be publishing online forms to facilitate Voluntary, Mandatory/ CMDSNet and Recall reporting. Information in the reports submitted electronically using the forms will be automatically entered in Health Canada's information management system. Along with the new forms, XML schemas will be available so that companies can output and submit reports directly from their proprietary systems.

Companies will be onboarded individually and the target is to have implementation in Spring 2016. Any comments relating to online forms can be provided to Collin Pinto, HPFB Inspectorate. Feedback relating to mandatory reporting and CMDSNet can be sent to Mary Raphael, Marketed Health Product Directorate.

10. Mandatory Problem Reporting

MEDEC requested information on whether Health Canada would consider implementing a pilot program similar to that of the US FDA for reporting medical device malfunctions. In the program, companies will submit a summary report on a quarterly basis for malfunction events related to a particular device model number and/or catalog number.

Mary Raphael, A/Director of the Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate (MHPD) indicated that in the past, Health Canada conducted a pilot study on summary reporting of mandatory problem reports with one industry stakeholder under two specific reporting scenarios. Currently, Health Canada is not considering summary reporting, as the current focus is on upgrading IT infrastructure, electronic form submissions, database renewal and improved reporting tools. For the longer term, Health Canada is interested in monitoring the results of the FDA's pilot program of summary reporting and may consider revisiting the topic.

11. Unique Device Identification (UDI)

MEDEC requested an update on the possibility of implementing a Unique Device Identification (UDI) System for Medical Devices in Canada. Nancy Shadeed, Special Advisor, International Programs Division, Bureau of Policy, Science and International Programs, TPD indicated that Health Canada is currently considering the specifics of how a UDI system may be implemented in Canada. At this time, Health Canada is not contemplating additional Canadian-specific requirements. TPD intends to share a draft implementation plan by summer 2016 for consultation with all interested stakeholders and looks forward to receiving MEDEC's feedback. Implementation of any UDI-specific requirements would only be considered after stakeholders have had an opportunity to comment on the draft implementation plan.

12. HPFB Transparency and Openness

Matthew Bown, Associate Director, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate; Collin Pinto, A/Manager, Medical Device Compliance Unit, HPFB Inspectorate; and Laura Johnson, Office of Planning, Performance and Review Services, TPD provided a joint presentation on this topic. Health Canada continues to move forward with the implementation of the Regulatory Transparency and Openness Framework (RTOF), which includes Summary Safety Reviews. HPFB is looking for feedback from MEDEC on what has gone well, what could be improved, and to seek feedback on potential new areas for transparency and any concerns the association has with the framework.

Additionally, HPFB will be exploring the expansion of the use of Summary Safety Reviews to medical devices. If there is a safety signal, the sponsor should be contacted by pre-market well in advance of the Summary Safety Review. The sponsor will then receive a 48-hour notification that a Summary Safety Review has been completed and will be published.

As part of the work under RTOF, TPD and BGTD launched two new transparency initiatives in 2015: the Submissions Under Review list and Regulatory Decision Summaries. TPD provided a presentation on the two initiatives and discussed next steps.

All health product inspections will be transparent and online by March 31, 2016. Medical Device inspections are expected to be posted in December 2015. The new government in Canada continues to move forward with openness and transparency initiatives.

MEDEC expressed concerns about the posting of negative decisions on the Health Canada website. Health Canada responded that negative decisions will only be posted for a specific subset. One more stakeholder forum will be held before moving ahead with the posting of these decisions. Patient groups have indicated that they appreciate the transparency.

Action: Collin Pinto, HPFB Inspectorate to pass on to colleagues MEDEC concerns about media interest in relation to the posting of initial inspection observations within three days of inspection.

Update: This information was passed on to colleagues responsible for project managing the transparency initiative and postings.

13. Roundtable

Updates on Policies and Guidances

Nancy Shadeed, Special Advisor, International Programs Division, Bureau of Policy, Science and International Programs, TPD provided the following updates:

• The consultation period for the Draft Guidance Document - Preparation of Premarket Medical Device Licence and Licence Amendment Applications for Dermal Fillers closed on October 27, 2015.
• The Guidance Document on the Risk-Based Classification System for In-Vitro Diagnostic Devices (IVDs) is expected to be finalized by the end of December 2015 and is expected to be posted on the Health Canada website for comments in January to March 2016.
• The Guidance for the Labelling of In Vitro Diagnostic Devices will be updated to include a notice on e-labelling and is expected to be posted as a Final Document on the Health Canada website in January to March 2016.

MedTech Conference

Klaus Stitz, MEDEC, updated that the MedTech Conference will be held April 26-27, 2016. MEDEC intends to hold a regulatory workshop around May 10-11, 2016 but will confirm the date and location.

14. Adjournment

Barbara J. Sabourin and Brian Lewis thanked everyone for participating in the meeting.

Meeting adjourned at 3:30 p.m.

15. Next Meeting

June 9, 2016

The meeting was chaired by Barbara J. Sabourin. The Record of Decisions is approved by Kimby Barton on behalf of Barbara J. Sabourin.

Original signed by:
Kimby Barton
Senior Executive Director
Therapeutic Products Directorate