The medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks. Especially, medical devices manufacturers willing to launch their products in the ASEAN geographies have to walk through stringent regulations, as different markets portray different Regulatory requirements.

In such a case, implementing an effective country or region-specific Regulatory strategy is the driving force to achieve compliance and avoid high Regulatory costs, far stretched timelines, unexpected product changes and operational challenges. But prior to devising the right Regulatory strategy, medical device manufacturers must have a clear understanding on the following:

  • Why Regulatory strategy must be part of corporate strategy?
  • ASEAN Medtech Market and Regulatory scenario
  • Factors influencing ASEAN Regulatory strategy
  • Importance of country-specific Regulatory connect
  • Merging compliance with cost-effective strategic approach (includes, clinical, testing and QMS components)

To help you understand the ASEAN Regulatory strategy, Freyr brings you a comprehensive webinar on, “ASEAN Regulatory Strategy: Medical Devices”, scheduled on March 10, 2021 for AMR, EU and RoW regions. Register now for comprehensive insights.



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