international regulatory overview 2009 rev linkedln

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


Accept New Challenges


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)


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


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


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


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


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


Health Canada


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



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)



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



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



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



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


Learn New Things


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



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



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


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



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



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



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



Conclusion

Thank you

Medical Devices & Biosciences Int’l (MDBIO Int’l)

Website WWW.Mdbioregulatory.ca


Be Curious & Show Some Initiative

international regulatory overview 2009 rev linkedln

Health & Medicine

medical devices japan

regulatory tools andabilities

regulatory affairs exportdate

food drug safety singapore

new challenges

shared activities

health canada

mandated activities