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March 17, 2009 International Regulatory Overview 1
International Regulatory Overview Canada - USA - Europe - Australia - Asia
By : Roger Leclerc - Speaker
Title : Senior Director, Regulatory Affairs & Export
Date: March 17, 2009
March 17, 2009 International Regulatory Overview 2
Accept New Challenges
March 17, 2009 International Regulatory Overview 3
Overview
Medical Devices Regulatory Overview - Country
1. Canada - Therapeutic Products Directorate (TPD) 2. United States - Food & Drug Administration (FDA) 3. Europe - Competent Authority (TUV, BSI) - Member
States 4. Australia - Therapeutic Goods Administration (TGA)5. Asia - Ministry of Health (MHLW - SFDA)
March 17, 2009 International Regulatory Overview 4
Canada’s Challenges
Regulatory & Program Modernization of the Food & Drug Act
Enforcement Powers - Consequences Non-Compliance Life Cycle of a Medical Device - Develop Investigational
Testing Inspection Strategy & Program Proactive - Surveillance of Safety & Effectiveness &
Post Market Activities - Inspections Experienced Resource Planning - Knowledge Transfer Adequate Funding - Meet Requirements Admin. Governance - Performance Standards International Transparency & Stakeholder framework Performance Measurement Framework for Success &
Continuous Improvement - Regulatory Process
March 17, 2009 International Regulatory Overview 5
United States - Challenges
Disputes Concerning Payment or Refund of Medical Device User Fees
User Fees & Refunds for Premarket Notification Submissions
Guidance on Postmarket Issues Device Specific Guidance's Standards Related Guidance's Cross-Cutting & Process Guidance CDRH Enforcement Discretion 510(k) Paradigm Summary Technical Documentation for Demonstrating
Conformity to the Essential Principles of Safety & Performance
March 17, 2009 International Regulatory Overview 6
Europe’s - Challenges
Medical Devices Directive (90/385/EEC and 93/42/EEC2) Risk-Based Classification Non-Regulated Medical Devices Implantable / Invasive Devices for Aesthetic Purposes Revision of the "New Approach" Essential Requirements National Specific Requirements Notified Bodies Info exchange Notified Bodies & Competent Authorities Cooperation between Competent Authorities Safeguard clause & withdrawal of certificate Vigilance Market Surveillance
March 17, 2009 International Regulatory Overview 7
Australia’s - Challenges
Regulation of custom made medical devices Third Party Conformity Assessment Bodies for Medical
Devices Supplied in Australia Technical Review of the Code of Practice for the
Tamper-Evident Packaging (TEP) General requirements for labels for medicines Remedial actions for medical devices Review of TGA actions Conformity assessment overview Conformity assessment for manufacturers
March 17, 2009 International Regulatory Overview 8
Asia’s - Challenges
Japan Revises GCP for Medical Devices & Drugs Indonesia Orders Foreign Drug makers to Manufacture In-
Country Diabetes Increasing Rapidly in China - Glucose Monitors India Proposes Quality Certification for Medical Devices Japan Works to Cut Drug and Device Lag Taiwan To Create Food & Drug Administration For Food &
Drug Safety Singapore Tightens Regulation on Medical Device
Advertising India Cracks Down on Fake Drugs
March 17, 2009 International Regulatory Overview 9
Health Canada
March 17, 2009 International Regulatory Overview 10
Medical Devices Strategic Objective - 2012
1. Regulatory & Program Modernization
Strengthen safety oversight - Adopt of life cycle approaches - Risk Management Framework
Increase & Strengthen Regulatory Tools and Abilities - Learn & Share - Jurisdictions
Identify shared activities with other jurisdictions Develop programs to provide consequences for
Non-compliance with regulations Amend Investigational Testing Regulations Investigational Testing Inspection Strategy &
Program - Compliance to GCP - Reporting to HC Strengthen Post Market Activities, Surveillance &
Safety & Effectiveness monitoring - Risk basis
March 17, 2009 International Regulatory Overview 11
Medical Devices Strategic Objective - 2012
2. Human Resources
Knowledge transfer - talented staff HR Planning - skills, experience - future Training of staff due to science & technology Develop a culture of cross training Working together - Three different directorates Therapeutic Product Directorate (TPD), Health
Products and Food Branch Inspectorate (HPFBI), Marketed Health Products Directorate (MHPD)
March 17, 2009 International Regulatory Overview 12
Medical Devices Strategic Objective - 2012
3. Adequate Funding
Cost recovery – Charging framework to cover the regulation, licensing & post market surveillance of health products & medical devices
Branch - Comprehensive review of programs & resources to ensure adequate funding to deliver mandated activities
Identify gaps in its activities - for emerging issues & meet strategies - Cabinet & Treasury Board to finance programs not funded by Recovery Cost
March 17, 2009 International Regulatory Overview 13
Medical Devices Strategic Objective - 2012
4. Governance & Business Transformation
Manage better - current Structure - Collaboration of the Directorate & Inspectorate to discuss Medical Devices Issues i.e. funding for programs
Therapeutic Products Directorate (TPD), Marketed Health Products Directorate (MHPD), Health Products and Food Branch Inspectorate (HPFBI))
Review of Structural Options for Longer Term - Review organizational structures to handle device
issues as the industry grows, Develop service standards - i.e. MDEL issuance
- Develop Performance Measurements for all aspects of the Medical Devices Program - outlining sustainable activities
March 17, 2009 International Regulatory Overview 14
Medical Devices Strategic Objective - 2012
5. Work in Partnerships, Effective, Transparent Communication
Focus Approach to International Cooperation - Global Harmonization Task Force (GHTF) - Share activities with Food Drug Administration (FDA), Therapeutic Goods Administration (TGA) - Harmonization of Regulatory System - Medical Devices - provide expertise - International & National Standards
March 17, 2009 International Regulatory Overview 15
Medical Devices Strategic Objective - 2012
Strong & Positive Partnerships with Stakeholders - Develop joint activities - organization - associations
- Canadian Border Services Agency - Address Non-compliant
devices entering Canada
- Engage stakeholders and provincial regulatory authorities to discuss and plan end user training - high risk devices
Improve Communications with Stakeholders - Identify & improve timeless of communications
- Registration & disclosure of Clinical Trial Information
- Rely on - Expert Advisory Committee - Mechanisms improve stakeholder Communications
March 17, 2009 International Regulatory Overview 16
Learn New Things
March 17, 2009 International Regulatory Overview 17
Regulatory Issues & Outcome - 2008 - 2009
1. Standards Recognition
New list of Recognized Standards Updated Feb 2008
Proposal to Remove 2nd Edition Dec. 15, 2008 & Move forward with Third Edition of IEC 60601-1
Input from the Medical Devices Companies is forthcoming to discuss appropriate way to move forward with 3 rd edition of 60601-1 & its associated standards
March 17, 2009 International Regulatory Overview 18
Regulatory Issues & Outcome - 2008 - 2009
2. Special Access Program
Advisory Panel - Provide Options - Posted Review documentation by Health Canada, listen to
presentations at a public forum Make propose recommendations and various options
for modernizing the Special Access Program A Report will be prepared and will be posted to the HC
website. Industry - invited to provide input
March 17, 2009 International Regulatory Overview 19
Regulatory Issues & Outcome - 2008 - 2009
3. Significant Changes
MDB increasing significant changes following recalls - safety & effectiveness
Industry is stating other jurisdiction is non significant MDB has instructed industry to discontinue sale of the
device MDB will expedite significant change amendments
related to a recall Industry is stating - Corrective & Preventative Actions
part of a recall must be clear and harmonized with other jurisdictions
MDB has invited industry to provide input - before revision of the guidance document
March 17, 2009 International Regulatory Overview 20
4. Sale of Unlicensed Devices
Industry - Hospitals, Buying Groups, Dealers, receiving quotes - new devices coming to Canada & unlicensed
MDB - A purchase process - based on promotion could be viewed as an activity vs. regulations
HC- No Intention to sell a device Not used on an individual Label the device not licensed in accordance with
Canadian Law Return device out of Canada if at a tradeshow The device to be under direct control of the company at
all times
Regulatory Issues & Outcome - 2008 - 2009
March 17, 2009 International Regulatory Overview 21
5. Device Establishment Licence
Section 44(1) No person shall import or sell a medical device unless - Establishment License
Importers wish to sell product - new manufacturer or new class from current manufacturer - applicant cannot import or sell these products until receipt of amended MDEL
Currently the one form - Requires 15 day notification - for administrative changes on the current MDEL i.e. corporate name changes, contact person
Regulatory Issues & Outcome - 2008 - 2009
March 17, 2009 International Regulatory Overview 22
6. New Food & Drug Act Liaison Office (FDALO)
Aimed at preventing & resolving disputes with Stakeholders
Mandate - Receive complaints, concerns or inquires - alleged acts, omissions, matters related to Food & Drugs Act, listen, offer options, facilitate, investigate
FDALO has no statutory powers to investigate- not give legal advice - change policies -
Ms Serena Siqueira Director of the Food and Drugs Act Liaison Office - Handle concerns from manufacturers - license delays - lack of consistency
Regulatory Issues & Outcome - 2008 - 2009
March 17, 2009 International Regulatory Overview 23
7. Modernization of the Food and Drug Act
Minister Clement Introduced Bill C-51 - April 2008 Proposes the modernization of how HC regulates
therapeutic products Supports the implementation of a life cycle approach
(Progressive Licensing) to the regulations of medical devices & pharmaceuticals
Industry requested that the term Recall be explored to Progressive Licensing - www.healthcanada.gc.ca/progressive_licensing Bill C-51 - http://www.parl.gc.ca/legisinfo/index.asp?
Language=E&Session=15&query=5420&List=toc
Regulatory Issues & Outcome - 2008 - 2009
March 17, 2009 International Regulatory Overview 24
Conclusion
Thank you
Medical Devices & Biosciences Int’l (MDBIO Int’l)
Website WWW.Mdbioregulatory.ca
March 17, 2009 International Regulatory Overview 25
March 17, 2009 International Regulatory Overview 26
Be Curious & Show Some Initiative