Malaysia Medical Device Registration

Qserve is your regulatory consultancy partner for medical device registration services in Malaysia.

Regulatory Compliance Medical Device Act (Act 737, 2012)

Malaysia Medical Device Registration

Qserve has in-house knowledge to assist you with entering the Malaysia medical device market. You can leverage CE marking and FDA approval, and our experts know exactly the next steps that need to be taken and guide you through the process of Malaysia Medical Device Registration. Market Access/Medical Device Registration in Malaysia.jpg?preset=content

Regulatory Compliance in Malaysia

How Qserve supports Malaysia Medical Device Registration

If you need a full Conformity Assessment Body (CAB) assessment for your medical device, Qserve can analyze your existing technical documentation to find possible gaps. We can also set up a market access strategy for you and assist you with device registration in MeDC@St. The market access strategy is useful when you are targeting multiple markets in Asia. Our team can also assist with clinical evaluation and Post-Market Surveillance. 

If you want more information on how we can assist you with the Malaysian medical Device Registration process, feel free to contact us.

Benefits of Qserve engagement

Worldwide medical device and IVD registration

  • Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
  • We specialize in helping clients achieve and maintain market access around the world.
  • Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
  • Qserve uses a practical approach to support you every step of the way. 


Do you need assistance with Malaysia Medical Device Registration or a go-to-market strategy?

Qserve is your trusted partner for market access in Malaysia.

Contact us

Market access to Malaysia

Do you want to learn more about the Malaysian market access regulation?

We help you with a quick overview of:

  • The Malaysia medical device registration process
  • Classification requirements
  • Regulatory requirements
  • Licenses
  • Important guidance links

Market access Malaysia

How Qserve can help

  • Regulatory market access strategy
  • Registration support in Malaysia
  • Technical documentation gap analysis
  • Classification assessment
  • Local independent license holding Malaysia
  • Translation of labels and IFUs based on requirements
  • Risk management
  • Clinical evaluation
  • Post-market surveillance
  • Vigilance reporting

Contact us

News and events

Latest blogs, upcoming events or on-demand webinars