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Malaysia Medical Device and IVD Regulatory Strategy Report

The Medical Device Authority (MDA) of the Ministry of Health in Malaysia regulates the Malaysian medical device and IVD market. All medical devices must be registered. Although medical device applications are ultimately approved by the MDA, all Class B, C, and D devices require initial review by a Conformity Assessment Body (CAB). CABs are third party reviewers accredited by the MDA.

Products with approval in a reference market—USA, Canada, Europe, Australia or Japan—are eligible for an abbreviated CAB review, which is called a "verification."

We can help you 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

Get more information about our regulatory strategy overview report service for Malaysia