Objective

 

The objective of this course is to provide an overview to technical professionals, particularly those in Research & Development and Regulatory Affairs, on the general legal requirements to bring a medical device product to market - whether it is the creation of a new product, or import/export of a product to a new market.

 

Description

 

This course will discuss medical devices in major international reference environments and select countries in Asia, medical device definitions and classifications.  The course will discuss the major pre-marketing regulatory challenges and potential strategical solutions in key Asian markets.

Advanced products such as combination products are interpreted differently by different agencies, and there tends to be more disparity among Asian countries compared to more mature Western agencies.  This course will discuss some of the challenges with such advanced products.

 

Course Outline

 

  • Introduction to RA – what is the role of RA

  • Introduction to major global reference regulations and harmonization:

    • US, Europe, Japan, Australia, Canada, IMDRF

  • Overview of regulatory environment in major Asian reference countries:

    • AHWP, ASEAN, ARPA

    • Singapore

    • China

    • Hong Kong

    • India

    • Future trends in regulatory development

  • Pre-market requirements and how to develop registration strategy for commercialization

    • Background

    • Classifications

    • GMP

    • Conformity assessment

  • Advanced products:

    • Combination products

 

Learning Outcome

 

Upon completion of this course the attendees will be able to:

  1. Understand major global reference regulations and harmonization efforts for medical devices

  2. Understand regulatory environment in key Asian markets for medical devices

  3. Understand general pre-market requirements and how to develop registration strategy for commercialization

  4. Understand the legal logics behind the definition and regulation of advanced products

In partnership with NUS

Academy of GxP Excellence since 2009

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