Dr Muralitharan Paramasua. -Bernama filepic
CYBERJAYA: A total of RM9,093 worth of unregistered medical devices were confiscated by the Medical Device Authority (MDA) on Sept 13, bringing the total value of seized devices to more than RM500,000 this year.
MDA chief executive Dr Muralitharan Paramasua said the raid was carried out on a company at Jalan Ipoh after it was suspected of selling medical devices without a registered licence under the Medical Device Act 2012 (Act 737).
"The raid, led by Tengku Anis Shafinaz Tengku Ab Rahman, involved 15 MDA personnel and two officers from the Sentul police headquarters.
"MDA received complaints about the company on July 6, and initial investigations found that the company did have an MDA licence but was also selling unregistered medical devices," he said at a press conference.
Following this, Muralitharan said MDA suspended the company's licence and ordered it to stop selling the medical devices immediately.
"But we later found out on Aug 16 that the company failed to comply and continued selling the items.
"We then decided to raid their premises and confiscate unregistered medical devices worth RM9,093.
"This includes seven boxes of latex examination gloves, 33 boxes of syringes without needles, 90 boxes of blood lancets, 146 boxes of wooden tongue depressors, one unit of ultrasound gel, 1,098 units of spandex crepe bandage, three boxes of disposable needle and nine sets of documents," he said.
The case is being investigated under Section 25(1) of Act 737 for selling medical devices despite the company's suspended licence.
The company's licence was suspended after it violated Section 22 of the same Act, which involves selling unregistered medical devices.
If guilty, the company can be fined RM200,000 or face jail time not more than three years or both.
Muralitharan added that a total of RM500,000 worth of unregistered medical devices were confiscated this year in five raids.
"The most common unregistered medical devices confiscated were condoms, contact lenses, examination gloves, and blood pressure devices," he said.
This year alone, Muralitharan said two medical company licenses were revoked, 14 licenses were suspended, nine companies received their license back after complying with regulations, and one company is currently being charged in court.
"All health-related companies and public personnel are advised to check an establishment's registered license and their medical devices via MDA's website www.mda.gov.my, or its medical devices database at mdar.mda.gov.my," he said.
