Webinar: Medical device compliance in Malaysia

About the webinar

Placing medical devices on the Malaysian market requires manufacturers and distributors to navigate the regulatory requirements established under the Medical Device Act 2012 set by the Medical Device Authority (MDA). Medical devices are subject to registration requirements and applicable conformity assessment procedures based on their classification and regulatory pathway.

This webinar provides an overview of Malaysia’s medical device conformity assessment and registration framework. It will introduce key considerations across medical device classifications and explain the role of conformity assessment within the registration process. The session will also look at how approvals from recognised overseas regulatory authorities may be used as part of the verification process for medical device registration in Malaysia, where applicable.

Why attend this webinar

This session provides medical device industry participants with a general overview of the regulatory framework and applicable processes for placing medical devices on the Malaysian market.

What you’ll learn

Conformity assessment 
Understand the roles and responsibilities of registered conformity assessment bodies when assessing technical documentation and quality management systems. 

Risk classifications 
Learn how medical devices are classified from Class A, the lowest risk, to Class D, the highest risk, within the Malaysian framework. 

Regulatory reliance 
Explore how prior approvals from recognised overseas regulatory authorities may be considered within the applicable Malaysian verification pathway. 

Documentation standards 
Get a general introduction to the Common Submission Dossier Template (CSDT) used for medical device registration.

Who should attend

This webinar is relevant for: 

• Medical device industry professionals 
• Local authorised representatives in Malaysia 
• Regulatory affairs professionals