REGULATORY UPDATE | LAW ENFORCEMENT REGARDING MDA PARTICIPATION IN PANGEA XV 2022 OPERATIONS

On August 9, 2022, the Medical Device Authority (MDA) Malaysia has released an announcement containing Operation Pangea XV, a global collective movement to take out major power-strengthening activities against the sale of medications and medical items that do not comply with the law, has been accompanied by MDA. The International Criminal Police Organization (Interpol) is in charge of organizing this operation, which includes participation from international police, caste, and health officials.

This operation is being coordinated in Malaysia by the Ministry of Health Malaysia's (MOH) Pharmaceutical Enforcement Division (BPF), with assistance from a number of other organizations, including the National Central Bureau (NCB)/Interpol Malaysia, the Royal Malaysian Customs Department (RMCD), the Malaysian Communications and Multimedia Commission (MCMC), Pos Malaysia, and CyberSecurity Malaysia. In this operation, which ran from June 22 to July 5, 2022, MDA took part. ‎

The focus of this operation was on medical masks, gloves, oximeters, thermometers, COVID-19 test kits, glucometers, contact lenses, and blood pressure monitors, and it involved monitoring a total of five e-commerce sites and three social media sites, including facebook, instagram, and tiktok. A link removal order was issued to the concerned parties after it was determined that 792 linkages in total violated section 5 of the Medical Devices Act 2012 (the 737 Act). ‎

MDA has seized three different medical equipment during entrance inspections conducted at KLIA, Penang, and Johor during Operation Pangea XV because the import of these medical goods is believed to have breached Articles 5 and 15 of the 737 Law. 2,400 pieces of medical equipment were among the seized items. 428 pieces of medical gloves, 207 units of bandages, 250 units of condoms, and 150 units of syringes are included in the shipment of COVID-19 test kits. ‎

To make sure that medical devices marketed to the general public are registered under section 5 of Act 737, MDA has also carried out 130 checks at pharmacies and other retail locations. A total of 79 medical devices sold by 42 examined establishments were found to be in contravention of registration requirements because they were not registered under section 5 of the 737 Act during the course of Operation Pangea XV inspections. Medical gloves (30 units of various brands) were the most often discovered unregistered medical equipment in this operation, followed by medical masks (12), thermometers (11), professional COVID-19 test kits (5), and other items. ‎

A raid on a business in Value, Negeri Sembilan, was one of the additional law enforcement operations conducted out during Operation Pangea XV. The business is accused of marketing medical gloves that were not registered under section 5 of the 737 Act without a license that was in force under that provision. The business has also distributed COVID-19 test kits for sale. During the raid, 94 units of COVID-19 test kits and a total of 26,400 units of medical gloves were seized.

MDA has increased public awareness efforts in addition to the aforementioned law enforcement measures by posting 22 times on social media, hosting two Facebook Lives, and mailing flyers and booklets to 130 pharmacies and retail stores that sell medical equipment to the general public. ‎

You can read the original source at: KENYATAAN MEDIA : AKTIVITI PENGUATKUASAAN DI SEPANJANG PENYERTAAN MDA DALAM OPERASI PANGEA XV 2022 – Medical Device Authority (MDA)