Medical Device Regulations in Asia-Pacific Markets

In this In-house course gain a practical advice on how regulations are being applied to enable you to maximise on this rapidly growing market.

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 Your Team Should Do The Course

Your team will:

  • 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

What Team Would Benefit

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.

Sample Programme Day 1

09.00 Registration and coffee
09.30 Course starts

Overview by Chairman

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

Sample Programme Day 2

09.00 Course starts

Review of Day 1

*
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