KUALA LUMPUR: A company in Puchong, Selangor was raided today by enforcement officers from the Medical Device Authority (MDA) from the Health Ministry (MoH) for not having a valid establishment licence.
MDA chief executive, Dr Muralitharan Paramasua said that the company was also distributing medical devices not registered with the MDA.
The raid was carried out as a result of intelligence gathering and complaints received involving the company.
"The raid was a success as 1,285 units of blood pressure monitoring devices and nine units of infrared thermometers were seized, with an estimated value of RM111,233.
"Most of the medical devices were sold to companies, clinics and individuals through e-commerce platforms or through direct sales. The company is believed to have been involved in the import of medical devices since October 2019," he said in a statement today.
The case is being investigated under Section 5(1) of the Medical Devices Act 2012 (Act 737), for importing, exporting or placing medical devices on the market without having an establishment licence.
Apart from this, the company is also being investigated under Section 44 (1) of the Medical Devices Act 2012 (Act 737), for advertising medical devices that are not registered under Act 737 which can lead to the company being fined not more than RM300,000 or face imprisonment of not more than three years or both if found guilty.
Muralitharan added that retailers, medical service providers and members of the public are advised to refer and double check on the establishment licence status of companies supplying medical devices and on the registration status of the medical devices via the MDA website at www.mda.gov.my or through the medical devices search system mdar.mda.gov.my.
Any complaints regarding medical devices and companies without valid licence
can be channelled via the MDA's response management system (MDAFEMES) at https://femes.mda.gov.my. - BERNAMA