Final Record of Decisions - October 20, 2014, 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

October 20, 2014 (1:00 p.m. to 3:50 p.m.)

MEDEC Participants

  • Brian Lewis, MEDEC
  • Klaus Stitz, MEDEC
  • Alan Coley, MEDEC
  • Diana Johnson, Alcon
  • Meghal Khakhar, Baylis Medical
  • Greg Leblanc, Cook Medical
  • Joseph Di Marzo, Covidien
  • Linda Lindsay, GE Healthcare
  • Sally Prawdzik, Lifescan
  • Noel Greaves, Medtronic
  • Althea Lawrence, Philips
  • Marie Louise Futter, Roche Diagnostics
  • Monica Magidin, Siemens Canada-Healthcare
  • Rochelle Gordon, Sorin Group
  • La-Toya Whittle, Stryker

Health Canada Participants

  • Barbara J. Sabourin, Director General, Therapeutic Products Directorate (TPD), Co-Chair
  • John Patrick Stewart, Executive Medical Director, TPD
  • Carey Agnew, Medical Devices Bureau (MDB), TPD
  • Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
  • Patricia Carruthers-Czyzewski, Marketed Health Products Directorate (MHPD)
  • Sarah Chandler, MDB, TPD
  • Cindy Evans, MDB, TPD
  • Colin Foster, MDB, TPD
  • Adam Gibson, Natural and Non-prescription Health Products Directorate (NNHPD)
  • Thomas Hazle, Health Products and Food Branch (HPFB) Inspectorate
  • John Helmkay, MDB, TPD
  • Nashwa Irfan, MHPD
  • Philip Neufeld, MDB,TPD
  • Mary Raphael, MHPD
  • Nancy Shadeed, Bureau of Policy, Science and International Programs (BPSIP), TPD
  • Donna Watt, OPPRS, TPD

Health Canada Observers

  • Marilena Bassi, OPPRS, TPD
  • Rebecca Bose, BPSIP, TPD
  • Nicole Charron, Strategic Policy Branch (SPB)
  • Mandy Collier, BPSIP, TPD
  • Genevieve Moore, Food and Drugs Act Liaison Office (FDALO)
  • Hugh Scheuerman, OPPRS, TPD
  • Hui Zheng, MHPD

1. Welcome and Introductions

John Patrick Stewart, Executive Medical Director, Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB) welcomed participants and a roundtable of introductions followed.

TPD is being challenged to show increased fiscal restraint, which includes actions such as limitations to TPD staff travel and conference attendance. A number of reductions in TPD staff have recently been made through attrition, and workload within the Directorate is being redistributed.

John Patrick Stewart mentioned a number of initiatives on which TPD has been working including the International Medical Device Regulators Forum (IMDRF), the Medical Device Single Audit Program, Bill C-17 and the Regulatory Cooperation Council (RCC).

Brian Lewis indicated that he and Klaus Stitz, MEDEC, met with HPFB's new Assistant Deputy Minister, Anil Arora, earlier that day.

2. Review of Agenda

No changes to the agenda.

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

The minutes of the March 3, 2014 meeting were approved. The following are the action items from that meeting:

Item 3b - Medical Devices Bureau (MDB) to provide more detail on changes required to reduce screening time. Update: MDB is finalizing a revised screening checklist and intends to share it with MEDEC once a final version has been approved.

Item 3c - MDB will provide a Webinar on Screening Deficiencies. Update: John Helmkay, MDB, and Klaus Stitz, MEDEC, are working together to schedule the proposed webinar.

All other action items have been completed.

4. Medical Device Bureau Performance Reporting; Marketed Health Products Directorate / HPFB Inspectorate Performance; HPFB Inspectorate Medical Device Establishment Licence Performance

John Helmkay, Senior Business Process Officer, Medical Devices Bureau (MDB), TPD, Thomas Hazle, A/Manager of the Medical Device Compliance Unit, Health Products and Food Branch (HPFB) Inspectorate and Mary Raphael, Associate Director of the Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate (MHPD), addressed this item. They provided a joint presentation on: 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; HPFB Inspectorate statistics; and MHPD statistics.

Action: John Helmkay, Medical Devices Bureau, and MEDEC to discuss the frequency of performance reporting and whether it will be done quarterly.

5. Medical Device Bureau Performance Reporting Format

The new slide deck format that was developed by the Medical Devices Bureau with input from MEDEC and the Marketed Health Products Directorate, and which includes added Inspectorate performance data, was presented in Item 4 above.

6. Consumer Health Products Framework

Adam Gibson, Director General of the Natural and Non-prescription Health Products Directorate (NNHPD), presented an update on the Consumer Health Product (CHP) Framework. In fall 2014, consultations will be launched on the new framework which is aimed at updating the current regulations for certain health products, such as cosmetics and hard surface disinfectants.

MEDEC noted that disinfectant products are classified by Health Canada as drugs, whereas the U.S. classifies them as medical devices.

Action: Adam Gibson, NNHPD, indicated that he would look at the submission that MEDEC made to the Regulatory Cooperation Council in relation to the classification and regulatory requirements for disinfectant products.

The Consumer Health Product Framework Consultation document can be found on the Health Canada website.

7. Implementation of IMDRF Work Item Results on SaMD and RPS/IHF

MEDEC requested an update on Health Canada's plans for implementation of the work products currently being undertaken within the International Medical Device Regulators Forum (IMDRF) regarding Standalone Medical Device Software Harmonization (SaMD) and Regulated Product Submissions (RPS)/Internationally Harmonized Format (IHF).

Nancy Shadeed, Special Advisor, Bureau of Policy, Science and International Programs, TPD responded that Health Canada sent an invitation letter on September 29, 2014 to medical device manufacturers to announce plans for an implementation pilot relating to the IMDRF Table of Contents. The invitation letter outlines the different phases and timelines associated with the pilot, which is planned to run from December 2014 to August 2015. Health Canada is working with the international regulatory community. Information about IMDRF and related work items and consultations can be found on their website.

8. Regulatory Cooperation Council (RCC) Joint Forward Plan

The Canada-United States Regulatory Cooperation Council Joint Forward plan was released on August 29, 2014. MEDEC submitted a letter to the Regulatory Cooperation Council (RCC) in October 2014 outlining eight distinct topics/areas for harmonization under the RCC work mandate. MEDEC requested a discussion with Health Canada on how a technical work plan could address the areas for regulatory alignment indicated in the letter.

Nancy Shadeed, Special Advisor, Bureau of Policy, Science and International Programs, TPD addressed this item. Health Canada assured MEDEC that the comments they sent to the RCC are being reviewed. However, some MEDEC points would require major changes in legislation. Also, since it is a joint initiative between two regulators, both sides have to agree to the work being advanced in this area. Health Canada and the U.S. Food and Drug Administration will continue to work closely together on regulatory convergence topics, including International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory harmonization.

9. E-Labelling

MEDEC requested an update on e-labelling capabilities for all Class devices provided for professional use. Sarah Chandler, A/Manager, Device Licensing Services Division, Medical Devices Bureau, TPD responded that the Medical Devices Bureau has incorporated e-labelling language in a revised draft labelling guidance document. On October 20th, Health Canada posted the following two draft guidance documents and two draft application forms for a 75-day comment period:

  1. Draft Guidance Document - Guidance for the Labelling of Medical Devices, Not Including In Vitro Diagnostic Devices - Appendices for the Labelling of Soft Contact Lenses, Decorative Contact Lenses, and Menstrual Tampons
  2. Draft Guidance Document - How to Complete the Application Form for a New Medical Device Licence
  3. Draft New Class II Medical Device Licence Application Form
  4. Draft Class II Medical Device Licence Amendment Application Form

The draft labelling guidance document expands the previous scope, which had only applied to Class IV devices, to include all Classes of devices that are not intended to be sold to the general public. Along with e-labelling, the draft guidance contains information on decorative contact lenses and Class II labelling requirements. These draft guidance documents are intended to: (1) assist manufacturers in complying with the labelling requirements under section 21-23 of the Medical Devices Regulations and (2) provide manufacturers with assistance on how to complete an application form for a new medical device licence.

10. New Reality for IT Device Types and Delivery Channels

MEDEC requested a discussion on Health Canada's regulatory approach to new concept devices, namely wearable devices, plug-in applications and mobile applications. The association indicated that many of these devices are sold through non-traditional channels such as downloads from a website or internet sales.

Colin Foster, A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau (MDB), TPD, provided clarification as to what types of wearable devices, standalone software and applications would qualify as medical devices. In relation to Health Canada's regulatory oversight on "non-traditional" marketing channels, MDB indicated that medical devices are only subject to the regulations if they qualify under section 2 of the Regulations. Examples of what would fall under the scope of the Regulations were also provided.

11. Requirement to Report DEHP and BPA in Medical Device Licence Applications

MEDEC requested a discussion regarding the Health Canada requirement to include information about Di (2-Ethyl hexyl) Phthalate (DEHP) and Bisphenol A (BPA) in licence applications. The association indicated that the presence of DEHP and BPA may have been over-reported by companies in order to facilitate the processing of their applications.

Sarah Chandler, A/Manager, Device Licensing Services Division, Medical Devices Bureau, TPD addressed this item. It is the expectation of Health Canada that manufacturers of medical devices know what materials are in their products. Both DEHP and BPA have been found to be toxic to the environment and to human health. The Canadian Chemical Management Plan (under the Canadian Environmental Protection Act) requires risk management. Environment Canada handles the environment but Health Canada does its own risk management for human health. Health Canada maintains that reporting the presence of BPA and DEHP in medical devices represents a minimum level of risk management and should not be onerous to manufacturers. The reporting required by Health Canada is not unique and is comparable, for example, to that required under the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

12. MEDEC MedTech Conference 2015

MEDEC shared information with Health Canada on the planning related to the MEDEC MedTech conference 2015. The association invited Health Canada to provide input that could assist with program development.

MEDEC appreciated the presentations that Health Canada provided at the 2014 conference. The association would like Health Canada to have a bigger profile at next year's conference. Health Canada reiterated that conference attendance is a challenge due to fiscal restraints but will discuss possibilities for the 2015 conference.

13. Roundtable

E-Submissions

Sarah Chandler, A/Manager, Device Licensing Services Division, Medical Devices Bureau, TPD, indicated that effective the day the notice was sent to manufacturers (September 26, 2014), the Medical Devices Bureau will be accepting electronic-only applications for Class III and IV devices, as long as they are in one of the formats described in the notice. As of December 1, 2014 any Class III or IV application that is submitted to the Medical Devices Bureau must be in one of the prescribed formats. These applications can be either paper or electronic, but e-submissions are strongly encouraged.

Risk Communication Template

Patricia Carruthers-Czyzewski, Manager, Risk Communication Section, Marketed Health Products Directorate, introduced this item. Health Canada has developed a single, streamlined, risk communication template to replace multiple current templates. Collapsible headings will be used to organize the information and increase readability. Health professionals and consumers will receive consistent information, with additional details tailored to each group. Rollout of this new template is anticipated in Winter 2014/15.

International Electrotechnical Commission (IEC) 60601 Standards

Linda Lindsay, GE Healthcare, indicated that the GE Global Design Team would like to be informed of any updates to the IEC 60601 standards. The team would also like the list to be updated more frequently.

Advisory Panel on Healthcare Innovation

Nicole Charron, Senior Policy Advisor, Office of Pharmaceuticals Management Strategies, Strategic Policy Branch, announced that the Advisory Panel on Healthcare Innovation, created by Minister Ambrose, has launched a Canada-wide consultation on healthcare.

Potential Medical Device Shortages

The request was made that MEDEC inform Health Canada if the association becomes aware of any medical device shortages.

3D Printing

MEDEC requested Health Canada input with respect to production of patient specific implants using 3D printing technology. The association inquired if these products would classify as "custom-made". Health Canada shares MEDEC concerns about the quality of material for these products but indicated that a number of innovative fronts are a challenge to regulate. MEDEC is welcome to share any information relating to this topic with Health Canada.

14. Adjournment

John Patrick Stewart thanked everyone for participating in the meeting.

Meeting adjourned at 3:50 p.m.

15. Next Meeting

Monday, March 2, 2015

Original signed by
Barbara J Sabourin
Director General
Therapeutic Products Directorate

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