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