In response to previous concerns over certain medical devices that failed testing, Malaysia’s Medical Device Authority (MDA) has released an update affirming that all implicated products have since been investigated, retested, and confirmed to meet regulatory standards.
This development follows a media statement released on 15 February 2025, which listed several devices sold online that initially failed safety and performance tests. Since then, MDA instructed the distributing establishments to conduct full investigations and implement corrective measures.
Corrective Actions & Retesting Outcome
MDA reports that all affected establishments have:
- Conducted comprehensive investigations into the test failures.
- Improved quality control systems.
- Retested the affected devices in accordance with Malaysian regulatory standards.
The outcome? All devices involved were found to be safe and effective for continued use after retesting, reaffirming their compliance with applicable standards.
Strong Industry Compliance with Post-Market Responsibilities
MDA acknowledged the high level of cooperation and responsibility shown by the establishments involved. These actions reflect their commitment to fulfilling post-market obligations under the Medical Device Act 2012 (Act 737), which requires establishments to ensure that devices supplied in Malaysia remain safe and effective throughout their lifecycle.
Efforts such as:
- Strengthening internal quality management systems,
- Adhering more closely to regulatory guidelines, and
- Enhancing transparency in addressing safety concerns have been crucial in restoring consumer trust.
Advice to the Public: Stay Vigilant When Buying Devices Online
MDA continues to urge the public to:
- Ensure any medical device purchased online is registered with MDA.
- Buy only from licensed establishments.
To support public safety, enforcement actions will continue against parties selling non-compliant medical devices. The authority remains firm in its stance: non-compliance will result in legal consequences.
For verification and complaints, visit MDA’s official website or call +603 8230 0300.
Published by MDA on 30 May 2025
