PETALING JAYA: Pulse oximeters, glucose and blood pressure monitors are among the devices that should be prioritised under the Hologram Security Label (HSL), says the Malaysian Pharmacists Society (MPS).
Its president Amrahi Buang said this was because such products could be easily sold to consumers through retail stores and e-commerce platforms.
“Fake or uncalibrated diagnostic kits can lead to misdiagnosis or delayed emergency care,” he said.
Besides such devices, which are readily available in retail stores and e-commerce platforms, Amrahi noted that high-risk and critical life-sustaining devices should also be prioritised for hologram labelling.
Among them, he said, were pacemakers, heart valves, implantable defibrillators, coronary stents and active implantable devices.
“Counterfeit or defective devices can lead to immediate fatality or severe disability.
“In the event of a defective device or counterfeit batch entering hospitals, precise batch-level tracking is crucial for initiating targeted recalls,” he cautioned.
Amrahi was asked to comment on a recent statement by the Medical Device Authority (MDA) on the phased rollout of the HSL for registered medical devices.
The announcement on the implementation of the HSL is scheduled to be made by the Health Ministry at the International Medical Device Exhibition and Conference on Aug 26.
Amrahi said having the HSL would prevent unregistered or substandard devices from entering hospital networks or procurement channels.
He said consumers could also cross-reference devices’ registration numbers with relevant sites such as the Malaysia Medical Device Register.
“Publicly accessible registries mean buyers do not need to rely on vendor trust, as they will be able to verify certificates independently,” he said, adding that the HSL would also align with international frameworks to ensure foreign-made devices meet international quality standards before being sold here.
Federation of Malaysian Consumers Associations (Fomca) secretary-general T. Saravanan said the HSL must serve as a practical verification tool to enable consumers to make swift checks before purchasing or using such devices.
“It should not simply be another sticker on a product.
“Most importantly, the verification result must be simple. Consumers should see a clear message indicating whether the product is verified or registered instead of having to interpret complicated regulatory information,” he said.
Meanwhile, MDA chief executive Dr Muralitharan Paramasua said the HSL would be implemented in phases as a strategic measure to strengthen post-market regulatory controls, enhance supply chain integrity and protect consumers.
He said the move was a new initiative akin to the Farmatag hologram safety label for pharmaceutical products introduced by the ministry in 2005.
“The success of the Farmatag hologram in helping identify registered products and combating counterfeit products has paved the way for the expansion of the initiative to the medical device sector,” he said in a statement.
He said the latest move would strengthen post-market controls and the supply chain in line with the nation’s aspiration of becoming a regional medical device industry hub by 2030, while promoting research, development and innovation in the sector.
