KUALA LUMPUR, Dec 30 — The Health Ministry today ordered a company distributing ‘headphones’ that allegedly reduce and control blood sugar levels to stop sales of the device immediately.
Health director-general Datuk Dr Noor Hisham Abdullah said the safety and efficacy of the device could not be verified as a review by the Medical Device Authority found it was not registered under the Medical Device Act 2012 (Act 737).
As such, he said the sales and distribution of the device should be stopped immediately until it was approved under Section 5 of Act 737 and the company obtained a valid establishment licence under Section 15 of the same act.
“According to legal requirements, a medical device to be imported, exported and placed in the market must first be registered under Section 5 of Act 737.
“In the process of registering, the level of safety and its effectiveness will be evaluated and verified. Any medical claim made must be supported by scientific and clinical evidence, than the device must meet the principles of safety and effectiveness,” he said in a statement today.
This was in response to an article titled “Headphones help lower diabetes patients’ sugar levels” reported in a portal dated December 20, prompting a number of public reactions that raised concerns about the safety and effectiveness of the device.
Dr Noor Hisham said the sale and distribution of unregistered medical devices or without a valid establishment licence was an offence and was liable to a fine not exceeding RM200,000 or imprisonment for a term not exceeding three years or both.
At the same time, he said any form of medical claims related to a medical device being aired for advertising purposes must comply with the advertising requirements laid down under Section 44 of the same Act and the Medical Device (Advertising) Regulations 2019.
According to him, any person who makes a false or misleading claim about a medical device in the advertisement is guilty and, upon conviction, could be fined not more than RM300,000 or imprisonment for not more than three years or both.
The public, especially patients receiving medical treatment for chronic diseases are urged to seek the advice of a registered health professional before using any device, in addition to checking the registration status by going to the official Medical Device Authority portal at https://portal.mda.gov.my/. — Bernama
