Greetings from the Medical Device Authority (MDA)!

We are pleased to announce that MDA will be conducting In-depth Training on General Medical Devices.

This comprehensive training session is designed to provide participants, comprising new establishments, conformity assessment bodies, and stakeholders, with an in-depth understanding of the essential topics related to general medical devices under the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012.

It will focus on risk classification, device grouping, the Common Submission Dossier Template (CSDT), Essential Principles of Safety and Performance (EPSP), clinical evidence requirements, and specific considerations for Software as a Medical Device (SaMD), particularly those incorporating AI/ML technologies.

Through interactive case studies, quizzes, and practical examples, participants will gain a hands-on understanding of how to meet regulatory requirements for medical device registration in Malaysia.

📅 Registration is now open until 5 May 2025.

🔗 Register here: https://forms.gle/EU7MxcXtPrMsy8cD6 or scan the QR code from the poster.

 

For further inquiries, feel free to reach out to us at trainingpackage@mda.gov.my.

We look forward to your participation!

Thank you.

Please click the link to view full information: In-Depth Training on General Medical Devices

Date updated: 22nd of April 2025