Medical Device Strategies for Success in China, Japan, and India Presentation

With the U.S. and European business climates in a downturn, the world is leaning toward Asia for growth. Tremendous opportunities abound in the China, Japanese, and Indian medical markets. Understanding how to enter, expand or deal with key regulatory issues in these markets is key to surviving in the competitive global market. From setting up your own branch in Japan to conducting clinical trials in India, this presentation will delve into the key business and regulatory issues in China, Japan, and India. Real case studies will be used to support main points.

 

To view these presentation slides, please click onĀ Medical Device Strategies For Success in China, Japan, and India Presentation

 

Table of Contents:

  • Asian Markets
    • Demographics
    • Health statistics
    • Size of drug, device markets
  • Market Research
    • Why do it
    • What’s the best approach
    • Potential pitfalls
    • How will such information affect your business and regulatory strategy
  • Distributor search and agreements
    • What types of distributors are available
    • How do you find the right distributor groups
    • What are key issues in the distributor agreements
    • Registration in your own name or the distributor’s name
  • Setting up your own office
    • Representative, Branch, Subsidiary, etc
    • What are some of the advantages/disadvantages of the above structures
    • What types of candidates are available and how do you find them
    • What types of regulatory people will you want in your Asian offices
  • Setting up Joint Ventures
    • What types of JV structures are there
    • How do you find the right partner
    • What pitfalls to avoid when setting up a JV
  • Research and Development in Asia
    • Which foreign medical companies are doing R&D in Asia
    • What strategies are they using
    • How do you protect your confidential information
  • Clinical trials in Asia
    • Advantages/Disadvantages
    • Picking the right CRO
    • Issues of Concern
  • Sourcing from Asia
    • Trends and benefits
    • Key steps
    • Regulatory issues
    • Key issues
  • Japan
    • Key business issues
    • Key regulatory issues
    • Best ways to deal with MHLW and PMDA
  • China
    • Key business issues
    • Key regulatory issues
    • Best ways to deal with SFDA
  • India
    • Key business issues
    • Key regulatory issues
    • Best ways to deal with CDSCO
  • Intellectual property issues
    • Enforcement of IP
    • Camouflaging your own documents
  • Cultural issues
    • Japan
    • China
    • India