Government considers regulation review for online medical device sales

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Health Deputy Minister Datuk Lukanisman Awang Sauni (centre) speaks at the Q&A session during the Medical Device Industry Players engagement session at BCCK. Photo: Mohd Alif Noni

KUCHING: The government is considering reviewing regulations regarding the sale of medical devices conducted through online business platforms.

Federal Deputy Health Minister Datuk Lukanisman Awang Sauni said selling medical devices online is a big issue at the moment.

“It will be unfair if our regulatory authority, through the Medical Device Authority (MDA), only takes action against sellers. Online selling platforms such as TikTok, Shopee, Lazada, and others should also take responsibility.

“They should be accountable, and some have suggested that these platforms should have a mechanism to remove all unapproved medical devices by MDA from their online sales,” he said during a press conference after officiating the Engagement Session with Sarawak Medical Device Industry Players 2024 at the Borneo Convention Centre Kuching here on Wednesday (Feb 14).

He added that these suggestions would require some adjustments to existing acts.

“This will involve Members of Parliament where the issue or proposal must be raised in Parliament for amendment.

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“For our part, we will study these views because this matter has been repeatedly raised during our engagement sessions.”

Earlier, Lukanisman said implementation of regulatory control under the medical device law is of great benefit to the public as all medical devices in the market must demonstrate compliance with safety and performance requirements as stipulated under Act 737.

“The regulatory control provides an appropriate framework for ensuring public health and safety by ensuring access to safe and effective medical devices while preventing sub-standard, unsafe and ineffective devices from reaching the market.”

He added that MDA as a government agency plays a crucial role in regulating and monitoring, ensuring all medical devices meet the requirements.

“On the other hand, the private sector is the lifeblood of innovation and product development, introducing the latest technologies that can improve patients’ quality of life.”

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