February 14, 2020
The Ministry of Health (MoH) was recently notified by the MDA on a 'headphone' device that allegedly reduces and controls blood sugar levels, published through a local newspaper. This headphone device claims to help lower blood sugar levels among diabetes users and has received multiple public concerns about its safety and efficacy. When checked with MDA, the device was found to have not been registered under the Medical Devices Act 2012 (Act 737) and therefore the safety and effectiveness of the device could not be verified.
As such, the Director General (D-G) of MoH has issued a stern warning to the company distributing the device to immediately stop the sales and distribution of the aforementioned device until it has been registered under section 5 of Act 737 and the company has obtained a valid establishment license under section 15 of the same Act.
MoH takes serious of such propagation of misleading medical claims, especially when they involve unregistered medical devices. In accordance with 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 a medical device, its safety and efficacy will be evaluated and verified. Any medical claim made must be supported by scientific and clinical evidence and the device must meet the principles of safety and efficacy as set out in section 4 of Act 737 and Third Schedule of the Medical Devices Regulations 2012 to prove it is safe to use and can achieve the intended use.
The law also stipulates that any person intending to import, export or place medical devices in the market must obtain an establishment license under section 15 of Act 737. Sale and distribution of unregistered medical devices or without a valid establishment license which, upon conviction, could be subject to a fine not exceeding RM200,000 or to imprisonment for a term not exceeding 3 years or to both.
In addition, any form of medical claim concerning a medical device that is aired for advertising purposes shall comply with the advertising requirements set out in Section 44 of the same Act and the Medical Devices (Advertising) Regulations 2019. Any person who makes a false or misleading claim a medical device in the advertisement is guilty of an offense and shall be liable to a fine not exceeding RM300,000 or to imprisonment for a term not exceeding 3 years or to both.
Press Statement by DG of Health, December 30, 2019 - Misleading Medical Claims and Unregistered Medical Device Distribution
Malaysia; MDA; Misleading medical claims; Unregistered medical device