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Malaysia Medical Device Regulatory Strategy Report

The Medical Device Authority (MDA) of the Ministry of Health in Malaysia regulates the Malaysian medical device market. New medical device regulations came into force in July 2013; prior to that time there was a voluntary registration system in place.

All medical devices must be registered, except certain Class A devices.

Evaluate the Malaysian medical device regulatory framework as it applies to your device(s)

Through our global network of in-house consultants, industry contacts and regulatory sources, Emergo provides in-depth coverage of multiple medical device markets, including Malaysia.

Our Global Regulatory Overview reporting service for Malaysia includes:

  • MDA Regulatory Background
  • Product Assessment
  • Authorized Representation in Malaysia
  • Medical Device Registration Requirements
  • Costs and Timeframes
  • Labeling and Language Requirements
  • Malaysia Regulatory Roadmap

Please contact us for more information about our Regulatory Overview Report for Malaysia.

Ask us for detailed information about Malaysia regulatory strategy services.

Learn about the process, costs and timelines.

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