Record of Decisions - November 19, 2009, 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: Thursday, November 19th, 2009

Start Time: 1:00 p.m.

End Time: 3:10 p.m.

Participants

MEDEC Participants

Stephen Dibert, MEDEC, Co-Chair

Klaus Stitz, MEDEC

Margaret Chong, Abbott care of (c/o) MEDEC

Laila Gurney, GE Healthcare c/o MEDEC

Arthur Kawasaki, BD Canada c/o MEDEC

Greg Leblanc, Cook c/o MEDEC

Linda Lindsay, St. Jude c/o MEDEC

Patricia Norman, BD Canada c/o MEDEC

Health Canada Participants

Supriya Sharma, Director General, Therapeutic Products Directorate (TPD), Co-Chair

Barbara J. Sabourin, Senior Executive Director, TPD

Roland Rotter, Medical Devices Bureau (MDB), TPD

Carey Agnew, MDB, TPD

Sarah Chandler, MDB, TPD

Gail Gervais, Liaison Unit, TPD

John Helmkay, MDB, TPD

David K. Lee, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD)

Philip Neufeld, MDB, TPD

Denise Quesnel, Liaison Unit, TPD

Christopher Rose, Health Products and Food Branch - Inspectorate (HPFBI)

Observers

David Y. Chen, OLRM, PPIAD

Mandy Collier, Bureau of Policy, Science and International Programs (BPSIP), TPD

Colin Foster-Hunt, MDB, TPD

Patrick Morin, Strategic Policy Branch

Fannie St-Gelais, Marketed Health Products Directorate (MHPD)

Douglas Watson, BPSIP, TPD

Brigitte Zirger, BPSIP, TPD

1. Welcome and Introductions

Dr. Supriya Sharma welcomed everyone and thanked people for taking the time to attend the meeting. Stephen Dibert, MEDEC, thanked Health Canada for the opportunity to meet. A roundtable of introductions followed.

Stephen Dibert, MEDEC, thanked Dr. Roland Rotter, Director, MDB, and his staff for their support at the Global Harmonization Task Force Steering Committee meeting held in Vancouver, British Columbia, the previous week; MEDEC received very positive comments; it was a successful meeting.

2. Review of Agenda

Some items were moved in order to allocate efficient time to address them. The Agenda was then approved.

3. Review / Update from the June 3^rd, 2009 Meeting

(Item 3 a) Definition of Sale in connection with Request for Proposals (RFPs)
Christopher Rose, Acting Manager, Medical Device Compliance Unit, HPFBI, sent the letter to TPD.  Sarah Chandler, Acting Head, Regulatory and Scientific Section, MDB, mentioned that the letter has been approved and sent to translation.  It will then be sent for posting.  If there are delays in posting, the letter will be sent to stakeholders.

(Item 3 b) Export Certificates
The HPFBI is looking at all the certificates, not only the medical device exports certificates.  It is anticipated that they will be harmonized in areas where possible.

(Item 6) Electrical Safety Authority (ESA) over Electrical Medical Devices
Christopher Rose to contact Province of Ontario.
Status: Completed / Another follow-up meeting with the Province of Ontario and the ESA was held on the 1st of November.

(Item 4) List of recommended or required changes for proposed integration into Health Canada's Progressive Licensing Project
David K. Lee, Director, Office of Legislative and Regulatory Modernization (OLRM), enjoyed attending the MEDEC conference. He confirmed that Health Canada is ready to re-table the bill for the revision of the Food and Drugs Act. Timing depends on the government. MEDEC's proposals for required changes have been considered.

(Item 4) BPSIP to Update MEDEC on the status of Clinical Trials/Investigational Testing (CT/IT) Consultations
Status: Completed / Roland Rotter gave an update at the MEDEC - Regulatory and Legal Conference, October 27^th, 2009.

(Item 12) Medical Device Establishment License (MDEL) Inspection Program Changes / MEDEC to send feedback from companies to the Liaison Unit (will then be forwarded to Christopher Rose-Inspectorate).
Status: Completed / Names of companies were received from MEDEC on July 23rd, 2009 and sent to the HPFBI on July 24^th, 2009. The plan is to post on the Health Canada Web site.

(Item 13) Roundtable / Draft of Hospital Letter
Mr. Dibert asked that Sarah Chandler, Acting Head, Regulatory and Scientific Section, MDB, to send him a copy of this letter.

4. Medical Devices Processed by a Third Party

Stephen Dibert, MEDEC raised the concern that some products claiming to be new devices, but have been reprocessed are being sold to hospitals. Mr. Dibert will have more details once the committee meets in December.

This item will be addressed again at the next meeting.

5. Draft Guidance on Significant Change

Sarah Chandler, Acting Head, Regulatory and Scientific Section, MDB, mentioned that the MDB is working on compiling the industry comments regarding the revised significant change guidance document.  This will probably not be completed until the new year.

Depending on the nature of the comments, it may be helpful to discuss a further revision with the already established Health Canada / MEDEC working group.

How MDB will deal with the increase in number of amendment applications is still something that needs to be resolved.  Mr. Kawasaki explained the reasoning behind the 30-40 % increase in applications.  This is the ratio that was deemed feasible by membership.

Arthur Kawasaki, BD Canada c/o MEDEC, encouraged participants to continue the high level of collaboration between MEDEC and MDB.

6. Change to Manufacturer's Address

Sarah Chandler, Acting Head, Regulatory and Scientific Section, MDB, provided clarification on the rationale for an attestation to be supplied for Class III manufacturing facilities.  MEDEC would like Health Canada to continue to allow address changes for manufacturers to be handled via a fax-back.

Ms. Chandler explained the situation where an amendment application is required.  If the manufacturer provides an attestation that the device specifications, performance specifications, materials, manufacturing process, quality control activities and labelling of the product except for the change in manufacturing facility address would be identical to that of the approved manufacturing facility, then the amendment would be approved without further evidence.  The attestation cannot be forward-looking.  Evidence must be submitted for review demonstrating that the device specifications are identical if there were any changes in the process, equipment, etc.

If a manufacturer of Class III/IV medical devices is only changing the legal manufacturer's name/address, this can be amended using the Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only.

7. Drug/Device Combination Submissions - Review Process and Timelines

Philip Neufeld, Acting Manager, Device Evaluation Division, MDB, addressed this item. He mentioned that TPD agrees that review times for combination products, especially drug eluting stents (DESs) exceed target times.  The increase in review time is in part due to the complexity of the submissions and additional review requirements for combination products.

Dr. Neufeld added that there was no immediate prospect of obtaining additional resources to review combination products.  MDB utilizes reviewers from the drug bureaux to review the drug components of DES.  An additional clinical reviewer was trained in 2008.

The reviews of the drug components for DESs are prioritized according to procedures in place for other drug products.

MEDEC enquired about the feasibility of disseminating Additional Information requests to manufacturers as each bureau completes their review.  Dr. Neufeld mentioned that questions from each review bureau have been emailed informally to the manufacturer before both device and drug reviews have been completed.  The purpose is to give the manufacturer additional time to prepare responses while the review of the remainder of the file continues.  In addition, questions have been issued by clarifax during the review instead of issuing an AI letter at review completion.

Dr. Roland Rotter mentioned that the Global Harmonization Task Force (GHTF) has prepared a document which outlines how the GHTF member countries deal with combination products.

Each file is assigned a regulatory lead based on the Primary Mode of Action (PMOA) of the product.  The primary contact of the regulatory lead is responsible for monitoring the process including communicating with the primary contact of each consulting bureau.  In some cases, emails have been sent requesting information.  There is ongoing discussion between MDB and the drug bureau.

Dr. Sharma recognized that it was a challenge, but until harmonization occurs, reviewers have to review both sides. Health Canada is working with the current process and is trying to streamline it.

Klaus Stitz, MEDEC, would like the combination devices added to the next performance presentation.

8. Medical Devices Bureau Backlog

The TPD received MEDEC's letter dated October 1, 2009, which proposed several suggestions to alleviate the Medical Devices Bureau's current backlog situation. The Bureau continues to consider and implement possible solutions and MEDEC's input is appreciated. MDB has formed a working group involving the Device Evaluation and Licensing Services Divisions to look at options to improve performance.

9. Medical Devices Bureau Performance

John Helmkay, Business Transformation Coordinator, MDB, provided the update on Metric and Performance for 2009.

Dr. Roland Rotter mentioned that employees in the MDB are proud of the work they do.  The backlog is due to the current environment, but improvements have been implemented.  There has been a tremendous drop across the board in the last quarter.  Dr. Rotter did not commit to any timelines for reducing the backlog.

Dr. Sharma addressed the current financial situation.  She mentioned that the Branch was in a deficit situation.  TPD is expecting no new money until at least 2012.  There has been an increase of 3 to 5% new submissions received.  TPD is looking at new ways to do business, and core review activities.  TPD is also looking at how it can incorporate the use of international reviews.

Dr. Sharma added that improving the quality of submissions would help reducing the backlog.

Stephen Dibert, MEDEC, encourages TPD to communicate any good news with MEDEC and offered its assistance in any areas that MEDEC can collaborate.

10. Clarification on Patient Management Software Notice

Sarah Chandler, Acting Head, Regulatory and Scientific Section, MDB, thanked MEDEC for providing comments on the patient management software notice. MDB is aiming to post a revised notice by the end of November for consultation. Many of MEDEC's suggestions will be able to be incorporated into the revised notice.

11. HPFBI Incident (Quarterly Statistics)

Christopher Rose, Acting Manager, Medical Device Compliance Unit, HPFBI, provided the slide presentation to the attendees before the meeting.

In terms of Trade Complaints, Klaus Stitz, MEDEC, would like to see the information on the status of a file, for example when it is open and closed.  Mr. Rose will see if it can be done for the next meeting.  Mr. Rose addressed the Inspections by activities.  He mentioned that Health Canada does not currently conduct foreign inspections, only on site inspections in Canada.

MEDEC to determine if a presentation regarding these statistics is required, or if a submission of the presentation deck to MEDEC will be sufficient.

12. Roundtable

1. E-Labelling and E-Prescribing

   Klaus Stitz, MEDEC, asked if e-labelling and e-prescribing would soon be available in Canada.  Could a compact disk (CD) be used instead of a hard copy?  Dr. Sharma mentioned that according to the minutes of the last meeting, it was agreed that it would not.  Medical Devices Bureau has stated that compact disks (CDs) that contains instructions for use with respect to training manuals, other types of training materials can be distributed to user, however a paper copy must be available should the user request it in paper form.

   Updates to certain portions of the instructions for use can be sent to the User either by CD or reference to their website.  This can only be done when the user has received the original instructions for use in paper form.

   Brigitte Zirger, Director, BPSIP, mentioned that it was on her Bureau's priority list.  Barbara J. Sabourin, Senior Executive Director, reminded the attendees of the Branch's financial situation.

2. Good News Story

   Dr. Roland Rotter mentioned that MDB will be achieving big numbers soon. It is expected that MDB will reach 3000 manufacturers and 30,000 licenses in late December or early January.

3. Dr. Rotter also thanked MEDEC for the GHTF meeting in Vancouver last week, to which it acted as co-chair.

13. Next Meetings:

• Wednesday, February 10th, 2010 at 1:00 p.m.
• Wednesday, June 23rd, 2010 at 1:00 p.m.
• Wednesday, November 17th, 2010 at 1:00 p.m.

14. Adjournment

Meeting adjourned at 3:10 p.m.

Original signed by
Dr. Supriya Sharma
Director General
Therapeutic Products Directorate