Malaysia Medical Device Market Country Report

The Medical Device Control Division (MDCD) of Ministry of Health Malaysia regulates the Malaysian medical device market. Although no formal requirements currently exist for medical devices in Malaysia, regulators are expected to roll out mandatory rules in the near future.

Let Emergo Group assist you in evaluating 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 Group provides in-depth coverage of multiple medical device markets, including Malaysia. If you would like to see what these reports include, you may download a sample Regulatory Overview Report.

Our Global Regulatory Overview reporting service for Malaysia includes:

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

Please contact us for more information or a free proposal about our Regulatory Overview Report for Malaysia.