The Medical Device Authority (MDA) of Malaysia is planning to introduce a hologram-based product authentication measure for selected medical device categories.
Based on the latest information shared following discussions between the Malaysia Medical Device Association (MMDA) and MDA, several aspects of the proposed implementation are still being developed and remain subject to MDA’s final confirmation.
No official implementation timeline has been announced. Implementation is currently not expected before 2027.
Purpose of the Initiative
The proposed hologram security label is intended to introduce an additional product authentication measure for selected medical devices in Malaysia.
Further details on the applicable device categories, implementation process, labeling requirements, and timeline are still under development.
Scope of Application
The hologram requirement is expected to apply only to selected medical device categories.
Current indications suggest that sterile products, including implants, are likely to be excluded. However, this remains subject to formal confirmation by MDA.
Manufacturers, Authorized Representatives, importers, distributors, and other stakeholders should therefore wait for the final requirements before making changes to existing labeling or packaging processes.
Key Updates
1. Hologram Requirement Expected for Selected Medical Devices
MDA remains committed to introducing a hologram-based product authentication measure, but it is currently expected to apply only to selected medical device categories.
The final list of affected products has not yet been confirmed.
2. Sterile Products and Implants May Be Excluded
Sterile medical devices, including implants, are currently expected to be excluded from the hologram requirement.
This remains subject to MDA’s final confirmation.
3. Implementation Timeline Has Not Been Confirmed
MDA has not announced an official implementation date.
Implementation is currently not expected before 2027.
A tentative pilot phase around February 2027 and possible mandatory implementation around July 2027 have been mentioned during discussions. However, these dates remain under consideration and should not be treated as confirmed implementation timelines.
4. Labeling and Operational Requirements Are Still Being Developed
Detailed requirements for hologram placement, labeling processes, implementation responsibilities, and other operational matters are still under development.
Industry concerns have been raised regarding:
- Over-labeling at manufacturing sites
- Operational complexity
- Potential impact on manufacturing and packaging processes
- Possible supply-chain implications
These concerns have been acknowledged by MDA.
5. Proposed Hologram Format
The hologram sticker is currently expected to be similar to the security label used for pharmaceutical products in Malaysia, subject to MDA’s final confirmation.
If the final hologram includes both the product registration number and Authorized Representative information, a separate AR label is expected to no longer be required.
This arrangement has not yet been formally confirmed.
6. Relationship Between Hologram and UDI Requirements
Based on the current indication:
- Products subject to the hologram requirement would not also require UDI.
- UDI would instead apply to products that are not subject to the hologram requirement.
Manufacturers should await MDA’s final clarification on how the hologram and UDI requirements will apply across different medical device categories.
Implications to Clients
Clients may continue with their ongoing Malaysia medical device registration and regulatory activities as usual at this stage.
No immediate changes to existing product packaging or labeling are required until MDA formally confirms the applicable hologram requirements.
Manufacturers should nevertheless be prepared to review existing labeling and packaging processes if their products are ultimately included within the scope of the hologram requirement.
Companies with overseas manufacturing or packaging sites may also need to assess potential operational and supply-chain impacts once the final implementation requirements are issued.
For sterile products and implants, the current indication is that these products may be excluded, but manufacturers should wait for formal confirmation before relying on this position.
Clients should also continue to monitor MDA updates regarding the relationship between the proposed hologram security label and future UDI requirements.
Key Actions for Companies
Manufacturers and other stakeholders should consider:
- Monitoring further MDA announcements on the hologram security label.
- Avoiding premature changes to existing packaging or labeling processes.
- Identifying products that may potentially fall within the selected categories.
- Assessing whether future hologram application could affect manufacturing, packaging, or supply-chain operations.
- Reviewing current AR labeling arrangements once the final hologram content requirements are confirmed.
- Awaiting MDA’s final clarification on the respective applicability of hologram and UDI requirements.
Effective Date
To be confirmed by MDA.
Implementation is currently not expected before 2027.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.