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Unlocking the Malaysian Medical Device Market: A 2024 Regulatory Guide

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Manage episode 493308145 series 3667504
Content provided by Pure Global. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Pure Global or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
This episode provides a detailed guide to Malaysia's medical device registration process. We explore the role of the Medical Device Authority (MDA), the foundational Medical Device Act 2012, and the critical steps manufacturers must take, from risk classification and conformity assessments to submission via the MeDC@St online system, including recent 2024 updates. • What is the primary legislation governing medical devices in Malaysia? • How does the risk classification (A, B, C, D) impact your registration strategy? • Are all device classes required to undergo a Conformity Assessment? • What is the MeDC@St system and who needs to use it? • Why is a Local Authorized Representative essential for foreign manufacturers? • What is a Common Submission Dossier Template (CSDT)? • How long is a medical device registration valid in Malaysia? • What key guidance document was updated by the MDA in January 2024? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.
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47 episodes

Artwork
iconShare
 
Manage episode 493308145 series 3667504
Content provided by Pure Global. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Pure Global or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
This episode provides a detailed guide to Malaysia's medical device registration process. We explore the role of the Medical Device Authority (MDA), the foundational Medical Device Act 2012, and the critical steps manufacturers must take, from risk classification and conformity assessments to submission via the MeDC@St online system, including recent 2024 updates. • What is the primary legislation governing medical devices in Malaysia? • How does the risk classification (A, B, C, D) impact your registration strategy? • Are all device classes required to undergo a Conformity Assessment? • What is the MeDC@St system and who needs to use it? • Why is a Local Authorized Representative essential for foreign manufacturers? • What is a Common Submission Dossier Template (CSDT)? • How long is a medical device registration valid in Malaysia? • What key guidance document was updated by the MDA in January 2024? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.
  continue reading

47 episodes

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