CYBERJAYA: More than 20,000 unregistered medical devices such as fertility test kits, pregnancy test kits and condoms were seized during an operation by the Medical Authority Devices (MDA), says Dr Muralitharan Paramasua.
The MDA chief executive said the MDA’s post-market and enforcement division had conducted a raid on a medical device supplier company in the Sungai Besar area in Selangor.
“The raid was led by Jevitra Tangarajoo and consisted of 18 MDA enforcement officers, the team were also assisted by three police officers on Nov 28.
“The company is suspected of distributing and selling unregistered medical devices online.
“Following the raid, the MDA successfully seized a total of 21,001 units of various types of medical devices, such as wound dressings in various sizes, fertility test kits, pregnancy test kits, condoms, and gauze swabs, estimated to be worth RM45,061,” he said in a press conference at the MDA headquarters here, on Friday (Dec 6).
Dr Muralitharan added that the company was also found to be operating without a valid license to distribute and sell medical devices.
He said the case will be investigated under the Medical Devices Act 737, Section 5(1), which concerns the import, export, or placement of medical devices in the market before registration, and Section 15(1) of Act 737, which concerns the import, export, or placement of registered medical devices in the market without holding an establishment license.
“Violations of both sections may result in a fine of up to RM 200,000 or imprisonment for up to three years, or both, if convicted of each offence,” he added.
It was also understood that the MDA was able to conduct the operation for more than six months following a tip-off from the public.
The authorities also found the company had been able to continue its business of selling medical devices imported from China, without being detected by the authorities, as it was operated from a home.
Following the matter, Dr Muralithran advised all retailers, healthcare providers and members of the public to check the status of an establishment’s licenses and the registration certificate of medical devices.
This can be done through the medical device search system at https://mdar.mda.gov.my/and and to obtain further information about legal requirements through the MDA portal at www.mda.gov.my.
“Any complaints regarding unregistered medical devices or companies operating without an establishment license can be submitted to the MDA via the MDA Feedback Management System (FEMES) for prompt action,” he said.
