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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.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

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

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Previous customers include...

  • Baxter Innovations GmbH
  • Biogen Idec Ltd
  • Cardinal Health
  • DEL MAR REYNOLDS MEDICAL LTD
  • ELA MEDICAL SAS
  • Fresenius HemoCare Netherlands BV
  • Fresenius Medical Care
  • Gyrus ACMI
  • JRI (Manufacturing) Ltd
  • KYPHON EUROPE
  • MEDITEC CONSULTING LTD
  • Medix Biochemica
  • Molnlycke Healthcare AB
  • N.V. Organon
  • Nice-Pak International Ltd
  • Nobel Biocare AB
  • Novo Nordisk A/S
  • OBS Medical Ltd
  • Orthofix Srl
  • Owen Mumford Ltd
  • Premier Research Group
  • Research Instruments Ltd
  • Septodont
  • Sinclair Pharma SRL
  • Summit Medical Ltd
  • Systagenix Ltd
  • Systagenix Wound Management
  • Tissue Science Laboratories plc
  • Tornier
  • Wellspect Healthcare