Registering a Device with the MDA in Malaysia
Questions? Request more information from our specialists
CONTACT USInterested in selling your medical device in Malaysia? General medical and IVD devices are regulated by the Medical Device Authority (MDA) of the Ministry of Health, and the regulatory process closely follows GHTF guidelines.
However, similar to other harmonized medical device markets, medical device manufacturers need to know about and comply with requirements that are unique to Malaysia. In this white paper, we provide an overview of the MDA registration process for medical devices.
You will learn:
- What are the Authorized Representative requirements for foreign manufacturers?
- How do we assess and classify our medical device according to MDA guidelines?
- What is the best regulatory pathway for our product?
- What are the steps in the registration process?
- How do we submit our registration documentation to the MDA?
We answer all these questions and more in this 6-page white paper.
About the Author:
Jetty van der Woude is a Senior Global Regulatory Specialist at Emergo. She has more than 10 years of experience in the medical device industry, and held positions at AEGON Health in The Netherlands, consulting firm ARCUSplus, and the US subsidiary of the Dutch medical device company Arion Group in Austin, TX before joining Emergo in 2010. Jetty holds a master’s degree in healthcare policy and management from Maastricht University and a minor in law from the University of Leiden.
Related
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Malaysia Regulatory Approval Process for Medical Devices
The chart shown illustrates Malaysia's approval process and is available for download in PDF format. However, if you would like to explain the step
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Malaysia Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Malaysia.
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