CYBERJAYA, Oct 5 — The Health Ministry’s Medical Device Authority seized various unregistered medical devices worth more than RM500,000 in five operations conducted in the Klang Valley, Johor, and Kedah this year.
MDA chief executive P Muralitharan said the four most seized medical devices were disposable gloves, blood pressure monitors, condoms, and contact lenses.
In addition, 16 companies had their licence suspended, the licence of two companies revoked, and nine companies had their licence returned after they were found to comply with the law.
He said in an operation carried out on September 13, a company operating in Sentul, Kuala Lumpur, was found to have repeatedly committed an offence of distributing unregistered medical devices.
“The company had its licence suspended in July after it was found to be distributing unregistered medical devices in the Malaysian market. But based on intelligence report, it was found that the company failed to comply with the instructions,” Muralitharan said at a press conference today.
Also seized from the premises were seven boxes of disposable gloves, 33 boxes of syringes without needles, 90 boxes of blood lancets, 146 boxes of wooden tongue depressors, 1,098 spandex crepe bandages, disposable needles waste and nine sets of sales documents worth about RM10,000.
The case was investigated under Section 25 (1) of the Medical Devices Act 2012 (Act 737), which provides a fine of not more than RM200,000 or imprisonment for three years or both upon conviction.
MDA is responsible for managing registration, sales license applications and evaluating medical device products before they are guaranteed safe for use in health facilities or for sale to consumers.
— Bernama
