PETALING JAYA: Long after the Covid-19 threat has been contained, unregistered medical devices such as facemasks, test kits, examination gloves and oximeters continue to be openly sold in the market.
Also found sold in the market – both at walk-in shops as well as online platforms – are digital infrared thermometers, plano (coloured contact lenses), condoms, first-aid kits and blood lancets.
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The Health Ministry’s Medical Device Authority (MDA) has found some 200 unregistered medical devices in recent raids.
MDA says there will be more raids coming up.
As of June, the MDA has already conducted three raids on the distribution of unregistered medical devices.
“All cases will be charged in court, possibly by this year,” the MDA noted in a statement to The Star.
According to the statement, devices such as ankle support, compression socks and kinesiology tape were also being sold to unsuspecting consumers.
“Most of these items have been imported from countries such as China, Thailand, Korea. These items are distributed by the local suppliers and some of the devices were imported directly by the users who purchase the medical devices via online platforms,” the MDA said.
The Medical Device Act requires all such items to be registered with the MDA before they are placed on the market, and establishments such as manufacturers, authorised representatives, distributors and exporters are required to be licensed.
All medical devices will also be subjected to assessment by a conformity assessment body to ensure they meet the essential requirements prior to registration.
Those who are found to have breached the laws will be subjected to warnings, suspension of their licences, seizure of the unregistered devices or even charges under the law.
Concurring with the MDA, Association of Malaysian Medical Industries (AMMI) executive director Ching Choon Siong said unregistered and counterfeit medical devices were being widely sold via social media and e-commerce platforms.
“The most common items are contact lenses, N95 respirators, surgical masks, Covid-19 test kits and other In-vitro diagnostic (IVD) test kits,” he said.
These devices could be imported via false declaration, he added.
“The sale of unregistered and counterfeit medical devices creates confusion and is dangerous to the public with its low quality, ineffectiveness, and unsafe track record,” he said.
To protect public health and safety, AMMI members and industry players are working closely with MDA to ensure medical devices sold in Malaysia are of high quality, effective and safe to use by the public, Ching said.
On June 13, the MDA raided a company in Batu Pahat, Johor, for selling unregistered medical devices to pharmacies and private clinics. Items worth more than RM300,000 were seized in the raid.
Earlier in March, another company in Puchong, Selangor, was raided, with 1,285 units of blood pressure monitoring devices and nine units of infrared thermometers worth RM111,233 being seized.
