Regulatory Strategy in Asia

Choosing the right Asian regulatory strategy is often a complex issue. Key factors in determining your regulatory strategy include:

  • What is the most cost-effective way to get your medical product registered?
  • What is the best strategy to obtain product reimbursement?
  • Are there local clinical trials required or can they be avoided?
  • Whose name can a foreign medical company register their medical product under?

In some of the Asian countries, it is difficult to separate your regulatory strategy from your business strategy. If your international sales and marketing executive sets up distributor contracts with local Asian distributors who do not have good in-house regulatory people, your medical products may have problems getting registered and sold. If you need to do local clinical trials for product registration and the cost of such clinical trials is prohibitive, your local partner may be willing to help with these costs.

Click on the countries below for more information on regulatory strategy in each Asian country and/or contact us to discuss your specific needs.

China Hong Kong Hong Kong India Indonesia Indonesia Japan Japan South Korea South Korea East Malaysia West Malaysia Malaysia Philippines Philippines Singapore Singapore Taiwan Taiwan Thailand Thailand Vietnam Vietnam


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