Indonesia’s government has officially issued Government Regulation No. 28 of 2024 concerning Implementing Regulation for Law No. 17 of 2023 concerning Health has been officially signed by Indonesia President, Joko Widodo on 26 July 2024. In order to increase health capacity and resilience within the framework of Health transformation to
On July 26, 2024, the Indonesia Ministry of Health (MoH) issued a letter numbered FR.01.01/E.V/1652/2024 regarding the Appeal for Filling in Pharmacy and Medical Device Dictionary Data (KFA). The Satu Sehat Logistik Platform (National Digital Inventory) is a platform for stock monitoring national drugs and Medical Consumable (BMHP: Barang Medis
On July 16, 2024, the Indonesia Ministry of Health (MoH) issued an announcement letter No. FR.01.01/E.V/1537/2024 regarding the Appeal for Filling in Medical Device Dictionary Data. The MoH has again requisitioned all companies holding active product licenses for medical devices to fill in the Pharmacy and Medical Devices Dictionary (KFA)
On June 7th, MDA launched the first phase of the pilot survey for the implementation of Unique Device Identification (UDI) in Malaysia. The survey will be conducted in two phases, involving the following establishments and timelines (dates updated July 30 2024): Phase 1: Class D Medical Device Establishments – June
On July 9, Thai FDA shared the following draft guidelines regarding license transfer and brand name amendment: The guidelines are set up for the applications that are eligible for referencing existing documents or document transfer from approval license which do not require an expert review of the documents. It covers
On July 10, Thai FDA shared an infographic regarding signage requirement for affected stakeholders: The registrants of an establishment for manufacturing or importing/licensed sellers of medical devices must arrange for signage display. The Signage must be displayed for the following: Medical device manufacturing facility Medical device selling facility Medical device
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