The Ministry of Health Malaysia (MOH) will gradually introduce and implement a Hologram Security Label for registered medical devices. This initiative builds on the existing hologram security label system, known as Farmatag, which has been used for pharmaceutical products under the MOH regulatory framework. The successful implementation of Farmatag in identifying registered products and combating counterfeit products has paved the way for this initiative to expand into the medical device sector. The Hologram Security Label will help consumers easily identify medical devices that are registered with the Medical Device Authority (MDA).

The introduction of the Hologram Security Label is expected to strengthen post-market surveillance in Malaysia by improving product traceability, facilitating the verification of medical device authenticity, and supporting enforcement against non-compliant medical devices. This initiative aims to reinforce Malaysia's post-market regulatory controls and improve the medical device supply chain. Additionally, it supports the country's objective of becoming a regional medical device industry hub by 2030. At the same time, it is expected to encourage further research, development, and innovation in the medical device sector.

The implementation of Hologram Security Label for registered medical devices is part of Malaysia’s ongoing efforts to strengthen regulatory oversight, ensuring that medical devices available in the market are safe, authentic, and properly registered. The initiative will be carried out through close collaboration between the MOH, MDA, and industry stakeholders to promote public access to safe and high-quality medical devices. The official announcement on its implementation will be made by the Minister of Health during IMDEC 2026 on 26 August 2026.

Preparing for Malaysia’s new Hologram Security Label requirements? With an onsite team at our Selangor office, Qualtech can support companies in reviewing medical device registration and labelling compliance, assessing potential impacts on existing products, and preparing for upcoming implementation requirements announced by the MOH and MDA.

Contact us to stay prepared for Malaysia's evolving medical device labelling requirements and maintain compliant market access.
 

References

PRESS RELEASE: IMPLEMENTATION OF THE HOLOGRAM SECURITY LABEL FOR MEDICAL DEVICES