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
Starting 01 July 2024, Payment via over-the-counter using LBP Oncoll Deposit Slip will be temporarily suspended until further notice. During this period, FDA encourages all concerned parties to utilize the following payment channels: LBP LinkBiz Portal DBP BancNet Bills Payment Over the Counter (for applications included in the Annexes of FDA
On 28 June 2024, the Vietnam Ministry of Finance issued Circular No. 43/2024/TT-BTC prescribing fees and charges to remove further difficulties for enterprises and support production and business activities. This circular reduces the fees and charges for some procedures from those regulated in previous guidelines. Accordingly, all fees and charges
In an announcement last June 26, 2024, TFDA released an additional list of experts, expert organizations, government agencies, or private organizations, both domestic and international, to perform the evaluation of academic documents on medical devices. This is according to Section 35/2, paragraph 1 of the Medical Devices Act B.E. 2551,
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