Final Record of Decisions - April 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

April 20, 2015 (1:00 p.m. to 3:30 p.m.)

MEDEC Participants

• Brian Lewis, MEDEC, Co-Chair
• Klaus Stitz, MEDEC
• Linda Lindsay, GE Healthcare
• Greg Leblanc, Cook Medical
• Young Kim, J&J Medical
• Sally Prawdzik, LifeScan Canada
• Meghal Khakhar, Baylis Medical
• Rochelle Gordon, Sorin Group
• La-Toya Whittle, Stryker
• Diana Johnson, Alcon
• Althea Lawrence, Philips Healthcare
• Danna Zylka, ConMed Linvatec
• Kofi Obeng, Siemens Canada (Observer)

Health Canada Participants

• Barbara J. Sabourin, Director General, Therapeutic Products Directorate (TPD), Co-Chair
• Cindy Evans, Senior Executive Director, TPD
• Carey Agnew, Medical Devices Bureau (MDB), TPD
• Marilena Bassi, Office of Planning, Performance and Review Services (OPPRS), TPD
• Janet Brunette, OPPRS, TPD
• Sarah Chandler, MDB, TPD
• Elana Cherry, MDB, TPD
• Mandy Collier, Bureau of Policy, Planning and International Programs (BPSIP), TPD
• Colin Foster, MDB, TPD
• Thomas Hazle, HPFB Inspectorate
• John Helmkay, MDB, TPD
• Laura Johnson, OPPRS, TPD
• Daphne Jurgens, Marketed Health Products Directorate (MHPD)
• Robert Leitch, MHPD
• Sara O'Connor, HPFB Inspectorate
• Etienne Ouimette, HPFB Inspectorate
• Jason Pearman, MDB, TPD
• Hugh Scheuerman, OPPRS, TPD
• Nancy Shadeed, BPSIP, TPD
• Colleen Turpin, MHPD
• Donna Watt, OPPRS, TPD
• Hui Zheng, MHPD

Health Canada Observers

• Nicole Charron, Strategic Policy Branch (SPB)
• 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.

There have been some organizational changes within TPD: John Patrick Stewart is now Director General of the Marketed Health Products Directorate; Cindy Evans is currently on assignment with the Director General's office in TPD as Senior Executive Director; Philip Neufeld and Fred Lapner of the Medical Devices Bureau have retired; and Bisi Lawuyi has been confirmed as section head for the Investigational Testing and Special Access Section, Device Evaluation Division, Medical Devices Bureau.

Brian Lewis, MEDEC Co-Chair, indicated that while there have not been many recent organizational changes at MEDEC, mergers and acquisitions continue to occur so there are likely to be changes in the future.

Barbara J. Sabourin, Director General of TPD, noted that the Government of Canada is making more data and information available to Canadians. As part of the Regulatory Framework, more documents will be posted on the Health Canada website. Summary Safety Reviews are currently being posted for pharmaceuticals and it is expected that in the future they will be posted for medical devices as well. Moving forward, a rationale will likely be posted for every regulatory decision. Under the openness and transparency initiative, TPD is posting a list of drug Submissions Under Review. This initiative will likely include posting of medical device applications under review in the future.

Under the new Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), there have been a number of regulations under development. Revisions to guidance documents are moving forward. Health Canada documents are expected to be finalized in shorter timeframes so consultation time will need to be balanced with providing Canadians with timely information.

Action: Carey Agnew, Medical Devices Bureau (MDB), to provide MEDEC with the name of the new quality systems analyst in MDB.

2. Review of Agenda

No changes to the agenda.

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

The minutes of the October 20, 2014 meeting were approved. The action items were either completed or added to this agenda.

4. MEDEC Strategy Review 2014/15

Brian Lewis, MEDEC Co-chair, presented highlights of the Association's strategic review for 2014-15. MEDEC is interested in engaging in a conversation about opportunities the strategy presents for the collaboration with Health Canada. MEDEC outlined various initiatives such as single use devices, vendor credentialing, GDSN bar code for procurement, and procurement and contracting. The Department of Foreign Affairs, Trade and Development will be placing an officer in MEDEC for three years with a view to learning more about medical device industry, experiencing the issues faced by the industry, and providing a trade development link with other countries.

5. Performance

Performance Metrics for TPD/MHPD/HPFBI

John Helmkay, Senior Business Process Officer, Medical Devices Bureau (MDB), TPD, Thomas Hazle, Medical Device Specialist, Medical Device Compliance Unit, Health Products and Food Branch (HPFB) Inspectorate and Robert Leitch, Associate Director of the Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate (MHPD), provided a joint presentation. The new performance reporting slide deck format was developed by MDB with input from MEDEC and includes Marketed Health Products Directorate and Inspectorate performance data. Information covered in the 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.

In response to MEDEC's question about posting the MDB quarterly reports on the website, Health Canada responded that due to common look and feel and accessibility requirements, it is difficult to post complicated diagrams and charts on the Health Canada Website. What will be posted on the Health Canada Website is that the document is available by request.

Action: John Helmkay, Medical Devices Bureau to look into MEDEC's offer to post the MDB quarterly reports on the publicly accessible section of the MEDEC website.

Update on the Canadian Medical Devices Sentinel Network(CMDSNet) Project

Colleen Turpin, Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate (MHPD) and Robert Leitch, Associate Director of the Marketed Health Products Safety and Effectiveness Information Bureau, MHPD presented an update about the Canadian Medical Devices Sentinel Network (CMDSNet) Project. A PowerPoint presentation was provided to the participants before the meeting for their review describing the year's accomplishments and future plans.

6. Performance Improvements on Applications

Screening Checklist

In an effort to reduce screening times for Class III and IV medical device applications and to move all requests for technical information to the review phase, the Medical Devices Bureau started piloting a new screening model on April 7, 2015. The Medical Devices Bureau is confident that the new model will allow review resources to be used more effectively. MEDEC was provided with a copy of the pilot screening checklist.

Action: MEDEC requested that this item be added to the Fall meeting agenda and that an update be provided.

Good Review Practices (GRP) Update: Report Card on Quality of Licensing Applications

Jason Pearman, Senior Evaluator, Device Evaluation Division, Medical Device Bureau (MDB) presented information on a pilot that MDB has initiated to collect data and to provide feedback to medical device companies on the quality of their applications. It is designed to help manufacturers ensure that future applications are of the best quality thereby improving the timeliness of MDB's review process. A draft quality feedback report card was circulated. Next steps for the pilot include undertaking a 12-month review, scoping a Phase II, and providing an update at a future bilateral meeting.

7. Update on the Status of Unique Identifier (UDI) Implementation in Canada

MEDEC requested an update on the status of UDI implementation in Canada. Nancy Shadeed, Special Advisor, International Programs Division, Bureau of Policy, Science and International Programs, TPD provided the update that Health Canada is currently analyzing the issues, options and considerations for a UDI system in Canada. It is anticipated that this analysis will be completed by the end of 2015. Health Canada is not contemplating any Canadian-specific requirements at this time. Health Canada indicated that once the analysis is complete, there will be opportunity for consultation before a guidance document is developed.

8. Transparency and Openness

Update: Post-market Health Product Transparency Initiatives

Daphne Jurgens, Senior Policy Advisor, Marketed Health Products Directorate updated that the Health Products and Food Branch has been publishing summaries of completed drug safety reviews since April 2014. This was one of the first commitments made under the Health Canada Regulatory Transparency and Openness Framework. There have been more than 25 Summary Safety Reviews (SSRs) published to date. The Branch will be adding medical device safety reviews to the scope of this initiative by the end of FY 2015-16.

The Branch also publishes a list of the safety reviews that have been initiated for drugs and natural health products so that Canadians can see which potential risk issues are being evaluated. This list is updated quarterly. Medical device safety reviews will be included in this list by the end of FY 2015-16.

In addition to the information that is now made available about post-market health product safety reviews, HPFB has also implemented other initiatives to increase transparency about health product safety:

Launch of the Health Product InfoWatch - this monthly publication expands on and replaces the Canadian Adverse Reaction Newsletter (CARN). It continues the CARN tradition of providing credible information on potential safety issues detected through the review of case reports submitted to Health Canada, but it will be published more frequently and will have an improved format.

Launch of the Drug and Health Product Register (DHPR) - This online database brings together and organizes health product information drawn from various areas and databases on Health Canada's website. Consumers and health professionals can access practical health product safety information including what a drug is used for, safety warnings and common side effects. They can also see what adverse reactions have been reported to Health Canada, and report a side effect quickly and securely using the online application. In this initial phase, the DHPR includes entries for about 350 prescription medications, including the top 100 prescribed drugs and biologics in Canada. The new site is mobile-friendly. Canadians are invited to provide feedback on their experience using the new register and on ways to improve it.

Regulatory Decision Summaries & Submissions Under Review

Laura Johnson, Good Review Practices Project Officer, Office of Planning, Performance and Review Services, TPD provided the reminder that on March 13, 2015, a Notice to Stakeholders was sent to DIN holders, medical device licence holders and major trade associations to announce new transparency initiatives being implemented under the Department's Regulatory Transparency and Openness Framework. As described in the Notice, Health Canada will begin to publish a list of Submissions Under Review (this applies to prescription pharmaceuticals and biologics, for human use), and Regulatory Decision Summaries (applies to Class IV medical devices, prescription pharmaceuticals and biologics, for human use), in a phased approach. A Regulatory Decision Summary Template for Devices handout was provided to MEDEC.

By April 2016, it is anticipated that the Submissions Under Review list will be expanded to include all new submissions. MEDEC should expect an invitation to a teleconference on the topic in the near future. Health Canada is planning to include information about the review decision in the form of Regulatory Decision Summaries for new class IV medical device applications. MEDEC noted that the process for pharmaceuticals is not automatically transferrable to medical devices. Health Canada is interested in receiving MEDEC feedback on the new transparency initiatives. Also, if MEDEC knows of any international organizations that are generating these types of summaries for devices, inform Health Canada.

HPFBI Transparency Initiatives

Etienne Ouimette, the new Executive Director of the Licensing and Inspection Bureau, HPFB Inspectorate noted that there are several transparency initiatives underway relating to inspections. While the present focus is Good Manufacturing Practices (GMP) for Drugs, the intention is to expand this initiative to other inspection types including medical device inspections conducted by Health Canada. It is expected that this information relating to medical device inspections will be posted in the future.

Since December 2014, Health Canada has published lists of inspections for Drug GMP as well as Inspection Report Cards for Non-Compliant inspections. This transparency initiative is being expanded to include Inspection Report Cards for all Drug GMP inspections, regardless of rating.

Sara O'Connor, Advisor, Licensing and Inspection Bureau, Health Products and Food Branch (HPFB) Inspectorate noted that most recent development is that the new Drug and Health Product Inspections Database was launched on April 13, 2105. Once the inspection of a facility is completed, within three days Health Canada will be posting high level findings of the inspection in the database. Within 30 days, a more detailed report card is entered into the searchable database. Results of retroactive inspections will not be posted unless a non-compliant finding was issued.

The Inspection Tracker, launched in February 2015, provides a snapshot of the potential health and safety issues Health Canada is tracking with companies that fabricate, package/label, test, wholesale, distribute or import drugs or health products for sale in Canada. This tracker is updated daily or as frequently as needed. The HPFB Inspectorate is open to any questions about these systems.

Action: MEDEC to provide feedback to HPFB Inspectorate on the company perspective in regard to the new transparency initiatives.

9. Roundtable

Special Access Program (SAP)

Carey Agnew, A/Director, Medical Devices Bureau (MDB) noted that in early April 2015, MDB sent out a SAP guidance to the SAP user group for comment. Klaus Stitz indicated that this information would be presented at the MedTech Conference that will take place on April 29-30, 2015.

Nancy Shadeed, Special Advisor, International Programs Division, Bureau of Policy, Science and International Programs, TPD noted that the Regulatory Cooperation Council (RCC) Work plans will be web-posted shortly. The development of Medical Device Single Audit Program (MDSAP) Guidance Documents are included as part of the Work plan. Health Canada noted that it has heard the RCC comments that MEDEC provided and that there is a stream for Canada-specific issues.

Updates on Policies and Guidances

Nancy Shadeed, Special Advisor, International Programs Division, Bureau of Policy, Science and International Programs, TPD noted that Health Canada's consultation period for decorative contact lenses closed on January 15, 2015. Final guidance documents will be web-posted with publication of final regulations.

There is an initiative to finalize guidance documents that are currently in draft form on the Health Canada website.

Tyvek Medical Packaging Transition Project

Klaus Stitz requested information on the status of Dupont's Tyvek project. MDB indicated that Dupont's information will be reviewed when it is received. Industry is concerned about amendment time for applications. Discussions with MDB will be ongoing on this topic.

10. Adjournment

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

Meeting adjourned at 3:30 p.m.

Next Meeting

Fall 2015

Original signed by
Barbara J Sabourin
Director General
Therapeutic Products Directorate