The Medical Device Authority (MDA) has conducted laboratory testing on six (6) types of medical devices as part of its market surveillance activities.
ECRI Berhad was appointed as the testing laboratory to carry out technical and performance evaluations of the identified medical devices based on the descriptions of complaints received.
A total of six (6) types of medical devices were tested due to high complaint frequency.
Read the full announcement here:
https://portal.mda.gov.my/index.php/announcement/1808-mda-perkukuh-pemantauan-keselamatan-peranti-perubatan-di-pasaran
Purpose of the Announcement
To inform stakeholders of MDA’s market surveillance activities involving laboratory testing of selected medical devices.
To strengthen monitoring of medical device safety, performance, and compliance in the Malaysian market.
Scope of Application
This announcement is relevant to establishments, manufacturers, importers, distributors, and stakeholders involved with medical devices in the Malaysian market, particularly products subject to complaints or post-market surveillance review.
Medical Devices Tested
The six (6) types of medical devices tested due to high complaint frequency are:
- Transfer Set
- Hemodialysis Catheter
- Hypromellose Eye Drop
- Surgical Glove
- Scalpel Blade
- Hemodialysis Fluid Filter
Table 1 – ECRI Summary Report provides the summarized laboratory testing results for the medical devices assessed as part of MDA’s market surveillance activity.
Read the supporting report here: Table 1 – ECRI Summary Report.pdf
Key Highlights
- Laboratory testing has been completed and results summarized for relevant stakeholders shown in Table 1.
- Results have been communicated to all involved establishments.
- MDA has instructed implementation of Corrective and Preventive Actions (CAPA) for affected medical devices.
- The purpose of CAPA is to ensure medical devices remain safe, effective, and compliant for use in healthcare facilities.
- MDA continues to strengthen post-market surveillance activities.
- The overall objective is to ensure only safe and effective medical devices are available in the Malaysian market.
Implications to Stakeholders
Clients are encouraged to proactively monitor product performance and ensure continued compliance with Malaysian regulatory requirements.
Clients may face increased regulatory scrutiny on product safety, performance, and complaint trends.
MDA may request additional technical clarification, testing data, or supporting evidence where required.
Establishments should ensure that complaint handling, post-market surveillance, CAPA documentation, and product performance monitoring systems are properly maintained and readily available for regulatory review.
Effective Date
4 June 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.