Record of Decisions - June 22, 2011, Canada's Medical Device Technology Companies (MEDEC)

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Contact: Office of Business Transformation

Health Canada - Health Products and Food Branch - Bilateral Meeting Program

Record of Decisions: Canada's Medical Device Technology Companies (MEDEC)

Location: 1600 Scott Street, Holland Cross, Tower B, 2^nd Floor, Boardroom 2048, Ottawa, Ontario

Date: June 22, 2011

Start Time: 1:00 p.m.

End Time: 4:30 p.m.

Participants

MEDEC Participants

• Stephen Dibert, MEDEC, Co-Chair
• Wayne Bryant, Medical Market Consultants (MMC), MEDEC
• Rochelle Gordon, Sorin Group
• Diana Johnson, Alcon Canada
• Young Kim, Johnson & Johnson
• Althea Lawrence, Philips Healthcare
• Greg Leblanc, Cook Medical Canada
• Linda Lindsay, GE Healthcare
• Monica Magidin, Siemens Healthcare Diagnostic
• Klaus Stitz, MEDEC

Health Canada Participants

• Supriya Sharma, Director General, Therapeutic Products Directorate (TPD), Co-Chair
• Sarah Chandler, Medical Devices Bureau (MDB), TPD
• Mandy Collier, Bureau of Policy, Science and International Programs (BPSIP), TPD
• Kevin Day, MDB, TPD
• Gail Gervais, Liaison Unit, Office of Business Transformation (OBT), TPD
• John Helmkay, MDB, TPD
• Dallyn Lynde, Marketed Health Products Directorate (MHPD)
• Genevieve Moore, Food and Drugs Act Liaison Office (FDALO)
• Philip Neufeld, MDB
• Denise Quesnel, Liaison Unit, OBT, TPD
• Mary Raphael, MHPD
• Carole Rivest, MHPD
• Roland Rotter, MDB, TPD
• Dobrila Todoric, MHPD (Teleconference)

Observers

• Monique Chaine, BPSIP, TPD
• Amanda Jones, Strategic Policy Branch (SPB)
• Sabah Khan, MDB, TPD
• Juan Ortiz, MDB, TPD
• Marc Poitras, MHPD

Regrets

• Nancy Shadeed, MDB, TPD, Health Products and Food Branch (HPFB)
• Christopher Rose, HPFB-Inspectorate
• Hieu Vu, Acting Senior Executive Director, TPD

1. Welcome and Introductions

Dr. Supriya Sharma, Director General, Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB), welcomed everyone and a roundtable of introductions followed.

1. Organizational Update
   Dr. Sharma mentioned that Meena Ballantyne, Assistant Deputy Minister (ADM) of HPFB has left for the Privy Council Office. Paul Glover has joined HPFB, as the new ADM, on February 7.

   Scott Sawler has joined the HPFB in December 2010, as Director General of the Natural Health Products Directorate (NHPD).

   Stephen Dibert, President, MEDEC, was pleased to report that Brendan Payne, MEDEC, has joined the Western Office in Vancouver.

   Mr. Dibert announced that he was planning to retire in the fall. The search is out for a replacement. The job has been posted on MEDEC's website.

2. Review of Agenda

The Agenda was approved.

3. Review / Update from the February 23, 2011

The minutes were approved. The actions were completed.

4. Cost Recovery

1. Cost Recovery (Funding Structure)
   John Helmkay, Manager, Office of Business Transformation (OBT), Medical Devices Bureau (MDB), TPD, provided the update on initiatives within Health Canada and MDB based on new funding structure.

   The new fee structure as it pertains to medical device activities has been in place since April 1, 2011. The Directorate is making strategic investments in Resources and Information Technology (IT) infrastructure to enable the Medical Devices Bureau to meet service standards under cost recovery. This includes, but is not limited to:

   • Enhanced Reviewer and Business Transformation Capacity - Targeted hiring and increased utilization of contractors;
   • Improved Workload Management - Development and testing of electronic tools for queue and workload management; and
   • Improved Planning and Application Quality - The Bureau is developing a formalized process to meet with selected manufacturers to discuss application pipelines, share application quality information, and develop strategies to reduce repeated application deficiencies.
2. MDB Performance Reporting
   John Helmkay, Manager, OBT, MDB, presented the performance metrics on both the pre-Cost Recovery and the new Cost Recovery service standards. The information included a detailed reporting of how the Bureau is managing these parallel lines of business.

   Mr. Helmkay explained the process for dealing with the workload for Class II, III and IV. Rochelle Gordon, Sorin Group, MEDEC, questioned the low numbers of submissions in backlog considering that several companies have backlog. Dr. Sharma confirmed that they were real numbers. She mentioned that reports and information more commonly available will be added to the Health Canada website. MDB is looking at strategy on how to handle the work flow. A team review approach is being adopted and resources are being shared with sections that are more behind.

5. Marketed Health Products Directorate (MHPD)

Mary Raphael, Associate Director, Marketed Health Products Safety and Effectiveness Information Bureau (MHPSEIB), MHPD, provided clarification on future strategies pertaining to medical devices.

The Canada Vigilance Program Initiatives and the Marketed Health Products and Safety Effectiveness Information Bureau (MHPSEIB) roles and responsibilities were discussed.

The Medical Devices Problem Reporting Transfer Project - Transferring the Activities of Medical Devices Problem Reporting from the Health Products and Food Branch-Inspectorate (HPFB-Inspectorate) to MHPD was discussed. Dallyn Lynde, Project Manager, MHPD, indicated that the transfer from the HPFB-Inspectorate to MHPD, was to consolidate with other products that are already with MHPD.

Medical device mandatory problem reporting is planned to be transferred to MHPD on October 3, 2011, adding another product line to the adverse reaction programs.

The integration of medical device problem reports data with the existing Canada Vigilance Adverse Reactions (AR) data management consolidates AR reporting in a horizontal approach consistent with each organization's mandate. The HPFB-Inspectorate delivers a national compliance and enforcement program. MHPD focuses on the Adverse Event data management and post market surveillance.

MHPD is developing some communications and web information that will provide updates to include the future program information. At this time, the only update is to include a change of contact information. Telephone and fax numbers may remain the same and simply be transferred to MHPD. The forms themselves may go through a format or design change to update their look, but the content will remain the same - Industry will be consulted on any content changes.

The involved Directorates and Bureaux, including Consumer and Clinical Radiation Protection Bureau (CCRPB), HPFB-Inspectorate, MHPD and TPD, have been working together on the transfer project to facilitate each others core business needs in regards to the new medical device problem reporting program.

As Health Canada is moving forward with this initiative, it will take advantage of the bilateral meetings to update stakeholders.

Linda Lindsay, GE Healthcare, MEDEC, mentioned that MEDEC would like to receive a heads-up on change and reporting activities from Mary Hill.

Dr. Sharma indicated that TPD was looking for more interaction with the provinces and territories. The recalls will remain with the HPFB-Inspectorate.

The HPFB-Inspectorate had also provided its statistics before the meeting. MEDEC had some questions, therefore will be contacting the Inspectorate directly.

Actions: MEDEC to contact Mary Hill, MHPD, for a copy of the report.

MEDEC to contact Christopher Rose, HPFB-Inspectorate.

6. International Electro-technical Committee (IEC) 60601-1, 3^rd Edition

Kevin Day, Head, Cardio-Vascular Section, Chair Standards Recognition Committee, MDB, addressed this item.

For the majority of the IEC 60601 standards where the particular standard exists, the transition date of June 2012 will be held. Health Canada is aware that in some cases, the IEC 60601 particular standards have not yet been published or have been published only recently, and this may make it difficult for some manufacturers to comply with the third edition of IEC 60601-1 by the transition date. Health Canada is working on developing an overarching approach to introducing transition periods for all recognized standards, and it is anticipated that this approach will ease some of the concerns associated with a limited transition period for certain particular standards of IEC 60601. Information on this new proposal will be provided in advance of June 2012.

It is worth noting that compliance to recognized standards in Canada is voluntary. In cases where an application for a new or amended medical device licence contains testing that is in compliance to a previous version of a standard, the manufacturer can provide a discussion on how and why the test data demonstrates the required safety and effectiveness of a proposed medical device.

Licences previously issued for devices compliant with Edition 2 of the IEC 60601 standards will continue to be valid, even after 2012. Also, if a licensed device complied with one or more collateral or particular standards aligned with Edition 2, the original licence will continue to be valid. That being said, as the Electrical Safety Code is regulated by Canadian Provinces, new equipment sold may have to meet Edition 3 of the IEC 60601 standards even if the manufacturer holds a valid medical device license based on Edition 2 testing.

After June 1, 2012, if a manufacturer applies for a significant change amendment to a licensed device that complied with Edition 2, Health Canada would request the modification to comply with Edition 3, unless the manufacturer can show that compliance with Edition 2 would not affect safety or effectiveness of the modified device.

Health Canada does encourage all manufacturers to transition to the third edition of IEC 60601-1 as quickly as possible, as this represents the most current thinking on the safety and essential performance of the technology covered by this family of standards.

A Notice or a Frequently Asked Questions (FAQ) document may be prepared by MDB informing companies that the 2^nd Edition will be accepted when the 3^rd Edition is not available.

7. Licensing Issues

Sarah Chandler, Acting Head, Regulatory and Scientific Section, MDB, addressed this item.

MEDEC would like that information be shared with MEDEC and stakeholders if changes are made as a result of new Standard Operating Procedures (SOPs) or policies within the Bureau. This will facilitate the proper filing of applications and subsequently their review and approval. Also, it was requested that MDB consults with the applicant on how devices are to be listed on Medical Devices Active Licence Listing (MDALL). Given that MDALL is visited by users and industry to check and to ensure devices being offered for sale are licensed, it is important to Industry that the licensed devices are listed on MDALL adequately (example- "assay" versus "reagents") and in a manner that is transparent to all. For Point 3, MEDEC members would like to hear how the voluntary use of e-Submissions for Class IV has been working and which experiences have been made.

1. Licence Type Classification / Licences Splitting
   Industry members have noted changes in the responses from the Device Licensing Services Division with regards to interpretation of Sections 28 to 31 of the Regulations (Licence Type), for example, the definition of what constitutes a device within an In Vitro Diagnostic Devices (IVDD) system. Whereas in the past, one assay would be one device (all elements required to perform an assay and fulfill its intended use: reagents, controls and calibrators whether sold together or separate), now the equivalent assay is being split into three devices within the system licence. MEDEC asked if this initiative is limited to IVDDs or were affecting other devices as well.

   There has been no change in the licensing of IVDD systems. In order to be a system, all of the components must possess a unique name AND the components of the system must be able to be used together to fulfill the intended use. A group of IVDDs without an analyzer cannot fulfill the device's intended use. Test kit licences do not contain analyzers, but system licences need to.

2. Administrative Changes
   Product codes constituting a "device group" were to be removed from a system licence and a new licence to be initiated for this existing "device group" via the administrative change process. It was noted that there is no mechanism for an administrative change to have a new licence not requiring any review. Health Canada has advised to submit form including a base licence fee per old form as there is no way to charge only an administrative fee for a Class III or IV licence due to the new fee structure. MEDEC is questioning the charge for another licence just to have a group licence for components that are already on a system licence.

   Since Health Canada no longer has the option of charging an administrative fee for Class III and IV medical device licence applications, the "group" catalogue numbers from "system" type licences will not be removed, as long as the group is just comprised of components of the system.

3. Mandatory use of the Summary Technical Document (STED) (Class III and IV) / Electronic Submissions
   MEDEC has received information (through involvement in the Group for Electronic Regulatory Applications (GERA) HPFB/Industry Group for Electronic Regulatory Applications) that Health Canada intends to introduce in the fall 2011:
   • The mandatory use of the STED format for Class III and IV applications submissions. It is MEDEC's impression that currently only STED for general Medical Devices (not IVDDs) have been endorsed by Health Canada (with Guidance) - IVDD STED still outstanding.
   • The movement to submission in eFormat for Class III and Class IV - although at this time not yet mandatory, but voluntary for Class IV.

   The use of the STED is strongly encouraged, however it is not mandatory. Electronic submission of Class IV applications is also strongly encouraged at this point, but not mandatory. However, it will facilitate the review. Health Canada will be posting an announcement to encourage MEDEC/stakeholders to use electronic submissions for Class III applications, as of September 1, 2011.

   Kevin Day added that he has noticed an increase in size of submissions. He encouraged MEDEC to submit a narrated final summary report and to avoid raw data.

8. MEDEC MedTech Conference 2011

Klaus Stitz mentioned that MEDEC will be holding a Canadian MedTech Conference, on November 1-2, 2011. This planned conference will have multiple streams over the two days in addition to a two day Regulatory Affairs stream. The Regulatory Affairs Conference offers an exceptional opportunity for Health Canada officials and Industry representatives to discuss current and future issues of the regulated products in Canada, impact of innovation, need for modernized regulation, to share and discuss each other's point of view in order to find equitable solutions or compliance to the benefit of patients.

The goal of the conference will be achieved by a mix of presenters from Health Canada (Medical Devices Programme) and industry plus discussion panels formed from representatives of both sides. Dr. Sharma mentioned that TPD will be identifying staff who could attend this conference.

9. Roundtable

1. Global Harmonization Task Force (GHTF) - Future Regulatory Harmonization and Removal of Red Tape
   Stephen Dibert, President, MEDEC, talked about the decision that was taken in March to remove the GHTF in the Spring of 2012. The Steering Committee met in May to plan on how to continue working in harmonization. There is an ongoing willingness for collaboration in the regulatory area. The next meeting will be held in the fall.
2. TPD Forward Planning Initiative
   Mandy Collier, Associate Director, Bureau of Policy, Science and International Programs (BPSIP), outlined three medical devices-related initiatives that are currently active in the Policy Division:

   The first is a proposal to amend the Medical Devices Regulations (Regulations) to require manufacturers of Class II devices to submit a copy of the device label as part of the device licence application. The Medical Devices Bureau currently requests manufacturers to voluntarily submit the label with the licence application, however, only 10% of manufacturers comply with this voluntary request. It is anticipated that this proposal will increase efficiencies by eliminating screening delays that result from requests for additional information following the filing of a Class II licence application.

   The second is a proposal to amend Part 3 of the Regulations - Medical Devices for Investigational Testing Involving Human Subjects - to address recommendations of the 2004 Auditor General Report. Among the proposed amendments being considered are:

   • the integration into the Regulations of several Good Clinical Practice (GCP) principles from GHTF and International Standards Organization (ISO) 14155 documents;
   • the addition and/or revision of definitions, including clinical investigation, qualified investigator, and investigator/research institution-sponsored trials; and
   • the addition of other requirements with respect to site information notification of trials discontinued or completed, a provision regarding amendments for significant protocol changes, and interim/final adverse event reporting for all devices authorized for investigational testing.

   A Cost-Benefit Analysis has also commenced to assess the resource and operational requirements of the proposed amendments. MEDEC members noted that they would like an exemption for in vitro diagnostic devices (IVDDs) from any new definition of clinical investigation and asked that any regulatory requirements respecting GCP principles not be prescriptive (GHTF versus United States GCP).

   The third initiative is the development of Notice on Health Canada's regulation of medical device reprocessing, refurbishing and reuse.  The Notice is intended to increase clarify and predictability for device stakeholders involved in these activities, and to facilitate compliance with the Regulations. The Notice is anticipated to be posted by Fall 2011.

10. Next Meeting

Wednesday, November 30, at 1:00 p.m.

11. Adjournment

Meeting adjourned at 4:30 p.m.

Original signed by

Dr. Supriya Sharma
Director General
Therapeutic Products Directorate