Off the market: Dr Muralitharan (centre) taking a closer look at one of the seized items during the press conference in Cyberjaya. With him are MDA Intelligence and Operations unit head, Dery Akmal Abdul Rahman and Jevitra. — AZMAN GHANI/The Star
CYBERJAYA: Over 20,000 unregistered medical devices, including pregnancy test kits, gauze swabs and condoms have been seized by the authorities after a six-month operation following a public tip-off.
The Health Ministry’s Medical Device Authority (MDA) post-market and enforcement division conducted the operation against a company based in Sungai Besar, Selangor, which was selling unregistered condoms, pregnancy test kits, as well as fertility test kits imported from China.
MDA chief executive Dr Muralitharan Paramasua said the company had been selling these imported items for three years, under the radar of authorities, as the sale was done from a home located in a rural area.
“The medical devices were imported through agents from China unlawfully. There is a standard operating procedure where those importing medical devices must get prior approval and registration from MDA before importing and selling the products here.
“The company had sold the medical devices online via shopping platforms, and we were alerted by netizens.
“This shows that the public is aware and acknowledge the importance of obtaining only registered and valid medical devices,” he said in a press conference at the MDA headquarters here yesterday.
Dr Muralitharan said as part of the operation, investigating officers purchased the medical devices, which were found to be unregistered and untested by the MDA.
“The raid was led by Jevitra Tangarajoo involving 18 MDA enforcement officers. The team was also assisted by three police officers on Nov 28.
“Following the raid, the MDA successfully seized a total of 21,001 units of various types of medical devices, such as wound dressing products in various sizes, fertility test kits, pregnancy test kits, condoms and gauze swabs, estimated to be worth RM45,061,” he added.
Dr Muralitharan said the company was also found to be operating without a valid licence to distribute and sell medical devices.
He said the case would be investigated under the Medical Devices Act 737, Section 5(1), which involves the import, export, or placement of medical devices in the market before registration, and Section 15(1) of Act 737, on the import, export, or placement of registered medical devices in the market without holding an establishment licence.
“Violations of both sections may result in a fine of up to RM200,000 or imprisonment for up to three years, or both if convicted for each offence,” he added.
The case will also be referred to the Malaysian Anti-Corruption Commission (MACC) as the company had used agents to import the unregistered medical devices.
Dr Muralitharan advised all retailers, healthcare providers and members of the public to check the establishment licence and the registration certificate of medical devices before making any purchase.
The checks can be done through the medical device search system at https://mdar.mda.gov.my/and.
To obtain further information about legal requirements, visit 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.
Dr Muralitharan said the authorities received good cooperation from online shopping platforms to detect unregistered or unauthorised medical devices sold at their respective sites.
“We have discussed with the online shopping platforms to follow a guideline when selling medical devices online. We hope to issue the guideline soon,” he added.
