Ensuring regional and global regulatory compliance whilst keeping abreast with the changing regulatory landscape of Asia



About the Event:

Asia faces formidable healthcare challenges with an ageing population combined with longer life expectancy, as well as changing diets and lifestyles. These challenges are dramatically altering the region’s health profile. With growing prosperity and increase in the Public & Private healthcare spending, the demand of Medical and diagnostic devices is also growing in the region.

Each Asian country has its own unique set of challenges and regulatory requirements, which often proves to be a daunting task for a global organisation to not only comply
to the different set of regulations but also keep themselves updated about the changing global healthcare regulatory scenario. Hence understanding the regulatory requirements and complying to the required safety, quality and efficiency standard is of importance for the medical device and diagnostic manufacturers.

The 2018 Asian Medical Device and Diagnostic Regulatory & Quality Affairs Meeting will provide a comprehensive overview of the medical device regulations and developments in Asia with focus on the 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.

The key highlights of the event are:

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  • ​​​​​​​Networking with the best minds from Medical Device and Diagnostic Regulations

  • Gaining insights on the medical device regulations in Asia

  • Regional Government updates on initiatives, reducing backlogs, new guidelines

  • Product Registration, Submission & Approval - Masterclass focusing on the region

  • Adverse event reporting system in Asia

  • Interpretation of new healthcare regulations in China, Singapore, Japan, Korea & ASEAN countries


Who Should Attend:

Executives that will find this program of greatest relevance are those currently working to implement regulatory

  • 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.