In My Crystal Ball I See

1
In My Crystal Ball I See

• Dr. R.G. Rotter
• Director, Medical Devices Bureau
• and Chair of GHTF

2
Overview

• Health Canadas Medical Devices Program
• Influences on work and activities
• Challenges
• Future Trends

3
Health Products Food Branch
Assistant Deputy Minister
Therapeutic Products Directorate
Biologics Genetic Therapies Directorate
Natural Health Products Directorate
Inspectorate
Office of Consumer Affairs Public Involvement
Food Directorate
Marketed Health Products Directorate
Policy, Planning and International Affairs
Directorate
Office of Nutrition Policy Promotion
Regional Offices
4
Medical Devices Bureau Structure
Director
Administration
Associate Director
Device Licensing Services Division
Quality Systems Unit
Device Evaluation Division
Device Surveillance Division
5
Medical Devices Bureau Responsibilities

• Provide regulatory interpretation and device
  classification decision
• Develop policy, guidance documents and regulatory
  amendments
• Issue licences (Classes II, III and IV)
• Manage Quality Systems Provisions of the
  Regulations
• Manage recognition of the Third Party Auditors
• Evaluate licence applications (Classes III and
  IV)
• Issue Investigational Testing (Clinical testing)
  Authorizations
• Administer the Special Access Program

6
Medical Devices Bureau Responsibilities
(continued)

• Perform laboratory evaluation of devices
  involved in incidents
• Conduct post-market surveillance
• Conduct research pertaining to medical device
  issues
• Establish and maintain international relations
  and activities
• Participate in global harmonization activities
• Participate on national and international
  standards development committees
• Provide technical expertise on litigation files
• Conduct health risk assessments
• Issue risk communications

7
Performance Standards

• Licences
• Class II - 15 days
• Class III - 75 days
• Class IV - 90 days
• Priority reviews 45 days
• Clinical Testing 30 days
• Special Access 3 days

Target is to process 90 of applications within
performance standard times
8
Licence Statistics

• In 2007
• 11,914 new and amendment applications processed
• 25,374 licences renewed
• 553 licences cancelled by the manufacturers
• 33 licences cancelled by the Bureau for non
  compliance with the regulations
• 159 clinical trial applications approved

As of July 2008 there were 27,000 active
licences accounting for gt 800,000 devices held
by 2700 manufacturers
9
Licence Holders
10
Activities Influencing Our Work Higher Level

• Departmental Level
• Strategic Review - Federal Government wide
• Bill C51 Modernization of the Food and Drugs
  Act
• Chemical Management Plan
• Branch Level
• Cost Recovery initiative

11
Activities Influencing Our Work Medical Devices
Program

• Auditor General of Canadas Report on the Medical
  Devices Program
• Timely access to new technologies
• Clinical testing
• Single-use devices
• Compliance and enforcement
• Program resourcing and design
• Human and financial resources
• Workload
• Litigation

12
Activities Influencing Our Work Medical Devices
Bureau

• Regulatory amendment for Clinical testing
• New licence application forms
• Includes request for information if product
  contains DEHP, bisphenol A and drug
  identification number requirement
• ISO 60601 phase-in
• New GHTF STED format
• Efforts to improve application quality

13
Challenges

• Reuse of single-use / reusable devices
• International collaboration and harmonization
• Quality management systems
• GHTF
• International relations
• Regulatory challenges
• Private Members Bills in Parliament and the
  Senate
• Combination products / Nanotechnology

14
Reuse of SUDs

• Health Canada does not regulate reprocessing by
  hospitals or third-party reprocessors.
• Health Canadas review of its regulatory
  authority indicates that the Food and Drugs Act
  does not grant authority to regulate reprocessing
  of devices.
• Regulation would require new legislation.

15
Quality Systems

• PILOT MULTI-PURPOSE AUDIT PROGRAM (pMAP)
• Joint FDA-HC effort to evaluate the effectiveness
  of using a single third party audit/inspection of
  medical device manufacturers to meet the
  regulatory quality system requirements of both US
  and Canada
• Reduction in audit/inspection related
  interruptions in the workplace leads to resource
  savings and a decrease in regulatory burden for
  manufacturers
• To date, 5 audits/inspections have taken place
  under the pMAP and an additional 3 are
  anticipated by the end of 2008.
• Recruitment of manfacturers and promotion of pMAP
  is on-going

16
Quality Systems

• Health Canada Therapeutic Goods Administration
  MoU
• To become operational, both the TGA and HC must
  complete the confidence building portion of the
  MoU.
• Final phase of confidence building exercise
  includes observed audits of medical device
  manufacturers
• Acceptance of a QMS certificate by either HC or
  the TGA should not be done unilaterally
• Current status
• Looking for a suitable candidate(s) for observed
  audit
• Need to perform successful observed audits

17
Quality Systems - Registrars

• Constant changing of registrars name, due to
  acquisition or other reasons, requires HC to
  update database of acceptable registrars.
• HC monitors and manages a registrars plan to
  transition a clients certificate from the old
  certificate to the new one.

18
Private Members Bills

• In the last Parliament there were 4 Private
  Members Bills before Parliament/Senate relating
  to medical devices
• Bill C-222 National Registry for Implantable
  Medical Devices
• mandated registry to be run by Health Canada
• Bill C-307- Phthalate Control Act
• medical devices that contain phthalate will be
  required to have labelling that states that the
  product contains this substance
• M-409 Cosmetic Contact Lenses
• motion to have cosmetic contact lenses regulated
  as medical devices in the same manner as
  corrective contact lenses
• New Bill on Bisphenol A

19
Regulatory Challenges

• Alternative medicine devices
• e.g. Biofeedback devices, magnetic therapy
  machines
• Biotechnology devices
• Drug/Device/Biologic/etc. Combination Products
• e.g. Drug coated stents
• What standards need to be met?
• How to handle new chemical entities that are
  being used for the coating of stents?

20
Regulatory Challenges

• IVDDs for home-use
• e.g. HIV test kits, Hepatitis C test kits
• Ethical concerns
• Nanotechnology devices
• Pharmacogenomics
• In-House Testing of IVDDs
• Do not have authority to regulate under the
  Medical Devices Regulations and Food and Drugs Act

21
Improving Application Quality

• Top 3 Screening Deficiency Reasons
• Safety Effectiveness Studies
• e.g. List of Standards/ Shelf-life/Stability/
  Biocompatibility/ Physical and Mechanical Bench
  Testing/ Clinical Studies/ Software Validation
• Background Information
• e.g. Marketing History/Regulatory
  Status/Incident Reports/ Device Description
• Licensing
• e.g. Licence Application Type/ Labelling and
  Packaging/ Fees

22
Improving Application Quality

• Top 3 Additional Information Requests
• Safety Effectiveness Studies
• e.g. List of Standards/ Shelf-life/Stability/
  Biocompatibility/ Physical and Mechanical Bench
  Testing/ Clinical Studies/ Software Validation/
  Analytical Performance/ Near Patient Clinical
  Testing/ Sterilization/ Validation/Re-sterilizatio
  n
• Manufacturing Quality Controls
• e.g. Sterilization/Validation/Re-sterilization/Bi
  oburden/ Devices Containing Biological Material/
  Manufacturing Process
• Background Information Marketing
  History/Regulatory Status Incident Reports
• e.g. Implant Registration System/ Indications
  and contraindications for use/ Device
  Description/ Design Philosophy

23
Future Trends

• Technological
• New technologies and challenges including
  nanotechnology, robotics, telemedicine, software
• Device linkage with information technology
  systems
• Greater sophistication of implantable devices
• Expanded use of imaging machines combined with
  non-invasive treatment techniques e.g. ultrasound
• Increase variety and complexity of combination
  products (device/drugs/biologics/other?)

24
Future Trends

• Workload and Regulatory
• Significant increases in number and complexity of
  applications
• Greater international harmonization and
  collaboration
• Changes in investigational testing requirements
• Unique device identifiers
• International
• Harmonization
• Development of common guidance documents
• Training of regulators from other jurisdictions