Presented by
Management Forum

Medical Device Regulations in Asia-Pacific Markets

Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market.

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  • Format: Bespoke training
  • CPD: 12 hours for your records (depending on your requirements)
  • Certificate of completion

Course overview

Now that the European medical device market is well established, the next growth area is Asia-Pacific. China, together with other countries in this region, have all implemented, or are in the process of implementing, their own medical device regulations. This seminar will provide a comprehensive overview of the medical device regulations and developments in China together with other newly regulated markets such as India, Hong Kong and Singapore. Practical guidance on how to comply with the requirements and gain access to these growing markets will be given.

Discover how these requirements are being interpreted and applied and how to maximise on this rapidly growing market.

Why you should attend

Benefits in Attending:

  • Gain an understanding of medical device markets in Asia
  • Hear an update on the Asia Harmonization Working Party (AHWP) & ASEAN
  • Be updated on the new medical device regulations in China
  • Comply with the requirements of the Japanese legislation
  • Gain an insight as to future developments in Hong Kong, Singapore, Malaysia, Korea, Taiwan, Indonesia and Thailand
  • Receive key advice on gaining access to these markets
  • An opportunity to share the wealth of experience with key experts in this region

Who should attend?

This seminar will be relevant to personnel from the medical device industry in the following departments:
  • Business development
  • Regulatory affairs
  • Registration
  • Quality assurance
  • Marketing
  • Manufacturing
  • R&D and technical affairs who would like to gain an understanding of the regulations in this region to gain access to these newly regulated markets

Programme – day one

09.00 Registration and coffee
09.30 Course starts

Overview by Chair

Overview of medical device markets in Asia
  • Changes in global regulations for devices
  • Market access – the big trends
  • Update on Australian regulations

Update on the Asia Harmonization Working Party (AHWP) & ASEAN

  • How are regulatory requirements being harmonised?
  • Benefits for industry and regulators

New medical device regulations in China

  • The key changes
  • Regulatory submission process
  • Product classification
  • Type testing
  • Key documents required
  • General timeframe/costs
  • Hints and tips for success

Current medical device clinical trial requirements in China

Medical device law (PMDL) in Japan

  • Regulatory submission process
  • Product classification
  • Key documents required
  • Clinical trial requirements

17.00 Course finishes

Programme – day two

09.00 Course starts

Review of day one

*
Newly Regulated Markets: Korea and Taiwan*

  • Regulatory overview
  • The application process
  • Authority reviews
  • Case studies

Newly Regulated Markets: Hong Kong

  • Regulatory overview
  • The application process
  • Authority reviews

Newly Regulated Markets: Malaysia and Singapore

  • Regulatory overview
  • The application process
  • Authority reviews
  • Case studies and interactive session

Newly Regulated Markets: Indonesia and Thailand

  • Regulatory overview
  • The application process
  • Authority reviews

Adverse Event Reporting Systems in Asia

  • Review of current adverse event reporting systems in key Asian countries
  • Harmonisatin perspectives
  • Future expectations

Delegates Questions and Answers Session

15.45 Course finishes

David Jefferys

Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices.

He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.

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David Pieratos

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Sumati Randeo

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Jack Wong

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We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss yor requirements.

UK

  • BD Diagnostics
  • Biogen Idec Ltd
  • Cardinal Health
  • Clinica
  • DEL MAR REYNOLDS MEDICAL LTD
  • Depuy CMW
  • Ethicon Products
  • Gyrus Medical Ltd (Cyrus ACMI)
  • Huntleigh Technology Limited
  • Informa Healthcare Limited
  • Johnson & Johnson Medical Ltd
  • JRI (Manufacturing) Ltd
  • Lifescan Scotland Ltd
  • Nice-Pak International Ltd
  • OBS Medical Ltd
  • Ortho-Clinical Diagnostics
  • Owen Mumford Ltd
  • PPD
  • Qiagen Manchester
  • Research Instruments Ltd
  • Sinclair IS Pharma
  • SSL INTERNATIONAL
  • Summit Medical Ltd
  • Systagenix Ltd
  • Systagenix Wound Management
  • Thoratec Europe Limited
  • Tissue Science Laboratories plc

France

  • ELA MEDICAL SAS
  • Ipsen Pharma SAS
  • Septodont
  • Tornier

Netherlands

  • Fresenius HemoCare Netherlands BV
  • Mentor Medical Systems B.V.
  • Merck Sharp & Dohme
  • N.V. Organon

United States of America

  • BD
  • CODMAN, J&J COMPANY
  • Fresenius Medical Care
  • Gyrus ACMI

Denmark

  • Coloplast A/S
  • Novo Nordisk A/S
  • Radiometer Medical ApS

Sweden

  • Molnlycke Healthcare AB
  • Nobel Biocare AB
  • Wellspect Healthcare

Switzerland

  • Institut Straumann AG
  • MEDITEC CONSULTING LTD
  • Premier Research Group

Italy

  • Orthofix Srl
  • Sinclair Pharma SRL

Australia

  • Leica Biosystems Melbourne Pty Ltd

Austria

  • Baxter Innovations GmbH

Belgium

  • KYPHON EUROPE

Finland

  • Medix Biochemica

Germany

  • CERAMTEC AG

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy