PEMBARUAN REGULASI | Penegakan Hukum Terkait Partisipasi MDA dalam Operasi Pangea XV 2022

On August 9, 2022, the Medical Device Authority (MDA) of Malaysia announced its involvement in Operation Pangea XV, a global initiative aimed at combating the sale of illegal medications and medical devices. This operation, organized by the International Criminal Police Organization (Interpol), involves collaboration from international police, health officials, and various agencies.

In Malaysia, the operation is coordinated by the Pharmaceutical Enforcement Division (BPF) of the Ministry of Health, with assistance from several 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. MDA actively participated in this operation, which took place from June 22 to July 5, 2022.

The focus of Operation Pangea XV was on monitoring and regulating medical items such as masks, gloves, oximeters, thermometers, COVID-19 test kits, glucometers, contact lenses, and blood pressure monitors. The operation monitored five e-commerce sites and three social media platforms, including Facebook, Instagram, and TikTok. A total of 792 links were identified as violating Section 5 of the Medical Devices Act 2012 (Act 737), leading to the issuance of link removal orders to the respective parties.

During entrance inspections at KLIA, Penang, and Johor, MDA seized three types of medical equipment believed to have violated Articles 5 and 15 of Act 737. Among the seized items were 2,400 pieces of medical equipment, including 428 medical gloves, 207 bandages, 250 condoms, and 150 syringes from COVID-19 test kits.

To ensure compliance with registration requirements, MDA conducted 130 inspections at pharmacies and retail locations, finding that 79 medical devices sold by 42 establishments did not meet the registration criteria under Section 5 of Act 737. Medical gloves were the most commonly unregistered items discovered, followed by medical masks, thermometers, professional COVID-19 test kits, and other products.

Additionally, a raid at a business in Value, Negeri Sembilan, was conducted during Operation Pangea XV. The establishment was found to be selling medical gloves that were not registered under Section 5 of Act 737, as well as distributing COVID-19 test kits. During the raid, 94 COVID-19 test kits and 26,400 medical gloves were confiscated.

Beyond these enforcement actions, MDA has increased public awareness efforts by posting on social media, hosting Facebook Live sessions, and distributing flyers and booklets to 130 pharmacies and retail stores selling medical devices to the public.

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