Ultrasound Machine
A medical device that uses high frequency sound waves to create real-time images of the inside of the body, helping doctors diagnose and monitor various conditions safely and painlessly
DW-P5
The P5 with 4D D-Live technology offers a complete solution that helps you with diagnostic confidence, efficiency and standardization in various diagnostic challenges in women’s health practice.
start from RM55,000
DW-T5
The rea-skin rendering is more intuitive, more three-dimensional, and more realistic. Can record every move of the fetus into a video, and present it on the monitor for real-time viewing and sharing.
start from RM95,000
Frequently Asked Questions (FAQ)
1. MDA Registration Explained
In Malaysia, all medical devices — including ultrasound machines — are regulated under the Medical Device Act 2012 (Act 737) and overseen by the Medical Device Authority (MDA).
2. What does MDA registration mean?
MDA registration confirms that a medical device has been approved for placement on the Malaysian market and complies with essential requirements for safety, performance, and quality, as mandated under Act 737.
3. Why is MDA registration important when purchasing an ultrasound machine?
Purchasing an MDA-registered ultrasound system ensures that:
- The device is legally permitted for sale and use in Malaysia
- Regulatory requirements for safety, performance, and traceability are met
- Proper after-sales support, servicing, and vigilance reporting are in place
- Clinics and healthcare facilities remain compliant during audits or inspections
- Use of non-registered devices may result in regulatory non-compliance and potential enforcement action.
- Sonobee as a Qualified Authorised Representative (AR)
- Sonobee is a qualified and registered Authorised Representative (AR) under the Medical Device Authority (MDA) framework.
As an AR, Sonobee is responsible for:
- Facilitating MDA registration of ultrasound devices
- Ensuring compliance with Act 737 and applicable regulations
- Maintaining technical documentation and post-market surveillance
- Supporting regulatory compliance for distributors and end users
- Devices supplied through Sonobee are placed on the Malaysian market in accordance with MDA requirements, subject to approved registration status.
4. What should buyers verify before purchase?
Buyers are encouraged to:
- Confirm that the ultrasound machine is MDA-registered
- Purchase only from Sonobee or authorised channels appointed by Sonobee
- Retain MDA-related documentation for compliance and audit purposes
5. Does MDA registration allow unrestricted use of the device?
No. MDA registration confirms device compliance, but actual use remains subject to:
- User qualification and training
- Facility licensing and internal SOPs
- Professional and clinical guidelines
- MDA registration does not replace professional responsibility or clinical governance requirements.
6. Compliance Statement
Sonobee, Ultrasound as a qualified Authorised Representative (AR), supports the responsible placement and use of ultrasound medical devices in Malaysia in compliance with Medical Device Act 2012 (Act 737) and MDA regulations.