Medical Device Authority - MDA

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Medical Device Authority - MDA Medical device regulations under Act 737 is aimed at ensuring safety and performance of medical devices in Malaysia

MDA is a government agency under the Ministry of Health Malaysia who is entrusted to implement medical device regulations under the Medical Device Act 2012 (Act 737).

Congratulations to Ybrs. Ts. Idamazura Binti Idris@Harun on being recognized as a Professional Technologist (Health & Me...
06/10/2026

Congratulations to Ybrs. Ts. Idamazura Binti Idris@Harun on being recognized as a Professional Technologist (Health & Medical Technology) by the Malaysia Board of Technologists (MBOT).

May this well deserved recognition inspire continued excellence, professionalism, and meaningful contributions to the advancement of health and medical technology in Malaysia.

Congratulations from the Management and Staff of the Medical Device Authority (MDA), Ministry of Health Malaysia.

🚨 The Regulatory Training: Post Market RequirementsFix your incident. Find the REAL root cause.Join us for a hands-on tr...
06/10/2026

🚨 The Regulatory Training: Post Market Requirements

Fix your incident. Find the REAL root cause.

Join us for a hands-on training session covering Root Cause Analysis (RCA) and Corrective & Preventive Action (CAPA) in a real regulatory environment.

📅 21 October 2026 (Wednesday)
⏰ 8:30 AM – 5:00 PM
📍 Cyberjaya/Putrajaya (TBC)
💰 RM1,000 per participant

Learn how to identify the real root cause, prevent recurrence, develop effective CAPA, and strengthen regulatory compliance and patient safety.

👥 Suitable for medical device manufacturers, authorized representatives, distributors, regulatory affairs, quality & safety officers, CABs, and quality & compliance professionals.

📌 Registration closes: 12 October 2026

📞 +03-8230 0300 (ext: 0211 / 0200)
📧 [email protected]

Driving Excellence in Medical Devices Ensuring safe, effective, and high-quality medical devices for public well-being.T...
06/10/2026

Driving Excellence in Medical Devices

Ensuring safe, effective, and high-quality medical devices for public well-being.

Together, we continue to strengthen excellence, innovation, and trust in Malaysia’s medical device industry.

🌐 www.mda.gov.my

🎙️ SEMBANG SANTAI MDA TIKTOK LIVEDropship & Reseller: Whose Responsibility Is It?Who is responsible when issues arise in...
05/10/2026

🎙️ SEMBANG SANTAI MDA TIKTOK LIVE

Dropship & Reseller: Whose Responsibility Is It?

Who is responsible when issues arise involving medical devices sold through dropshipping or reselling? 🤔

Join our Sembang Santai Peranti Perubatan session with:

Mrs. Khairunnisa Anati Binti Zahid
Assistant Director, Enforcement Division

📅 7 October 2026 (Wednesday)
🕙 10.00 AM
📱 TikTok Live:

Gain valuable insights and clarification on the responsibilities of dropshippers and resellers in ensuring that medical devices being marketed comply with regulatory requirements.

Ask, Listen & Learn!

Choose wisely. Choose registered medical devices.When purchasing a medical device, always make sure it is registered and...
05/10/2026

Choose wisely. Choose registered medical devices.

When purchasing a medical device, always make sure it is registered and complies with the required standards and regulations. A registered medical device helps ensure safety, quality and effectiveness for you and your family.

Make an informed choice. Check, verify and trust.

Learning to have faith in the process, even when I don’t understand where it’s leading me. 🤍Some seasons are about waiti...
02/10/2026

Learning to have faith in the process, even when I don’t understand where it’s leading me. 🤍

Some seasons are about waiting, some are about growing, and some are about letting go. But through it all, I’m choosing to trust that everything will unfold in its own time. What feels uncertain today may make perfect sense tomorrow.

Keep the faith. Keep praying. Keep going.

MSAS/-

01/10/2026

Understanding the Definition of a
Medical Device

What exactly qualifies as a medical device? Discover the key definition under the

Medical Device Act 2012 (Act 737) and how it distinguishes medical devices from medicinal products.

Source: MDA/GD/0006, Second Edition, 30 March 2026

MSAS/-

30/09/2026

Our Recap for MDA’s TikTok Sembang Santai Session is here!!!!!!

Don’t worry, we’ve got you covered!

Let’s recap our interesting topic on “The Role Of MDA In Supporting The Medical Device Industry ”.

Moderator:
Mrs. Norhafizah Binti Mohd Saleh,
Principal Assistant Director,
International & Industry Relations Division.

Don’t forget to watch!

MSAS/-

Visit MDAR MDAR is your gateway to Medical Device Registration.Access the Medical Device Authority Registration (MDAR) p...
30/09/2026

Visit MDAR

MDAR is your gateway to Medical Device Registration.

Access the Medical Device Authority Registration (MDAR) portal for reliable information and registration services.

🌐 mdar.mda.gov.my

Navigate Medical Device Compliance with Confidence In the fast-evolving healthcare landscape, staying ahead of regulator...
29/09/2026

Navigate Medical Device Compliance with Confidence

In the fast-evolving healthcare landscape, staying ahead of regulatory changes is crucial for business growth and patient safety.

Introducing MDA RIS (Regulatory Information Subscription). Your direct line for timely, accurate and relevant medical device updates from the Medical Device Authority (MDA) Malaysia.

MSAS/-

Address

Aras 6, Prima 9, Prima Avenue II, Block 3547, Persiaran APEC
Cyberjaya
62100

Opening Hours

Monday 09:00 - 13:00
14:00 - 15:00
Tuesday 09:00 - 13:00
14:00 - 15:00
Wednesday 09:00 - 13:00
14:00 - 15:00
Thursday 09:00 - 13:00
14:00 - 15:00
Friday 09:00 - 13:00
14:00 - 15:00

Telephone

+60382300300

Website

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