Greetings from the Medical Device Authority (MDA)!

You're invited to our upcoming training session:

🖥️ Fundamentals of Software as a Medical Device (SaMD)

📅 Date: One-day course

📍 Registration Deadline: 10 July 2025

🔗 Register here: https://forms.gle/vhxAEDtaZpghQtAh6

 

What You’ll Learn:

What SaMD is and how it differs from SiMD

Malaysia’s regulatory requirements (Act 737)

Risk classification for SaMD, SiMD, and AI-based devices

Software validation, clinical evaluation & post-market surveillance

Global vs. local regulatory practices

 

Who Should Attend:

Regulatory affairs personnel

Medical device manufacturers/importers

Healthcare software developers

Clinical/technical evaluators

Conformity Assessment Bodies (CABs)

Anyone involved in medical device regulations

📩 Questions? Email: [email protected]

 

We hope to see you there!

 

To view in PDF format, please click here:  Fundamentals of Software as a Medical Device (SaMD)

 

 

 

 

 

 

Prepare by: MDA-CoRE Unit

Uploaded by: Corporate Communication Division

Date of update: 10 June 2025