WebJan 24, 2024 · At this time, approvals using CSDT documentation from the following competent authorities will receive an expedited review: Singapore’s Health Science Authority (HSA), Thailand Food and Drug Administration (TFDA) approved under the new regulations implemented in February 2024, Malaysia Medical Device Authority (MDA), Indonesia’s … WebSep 6, 2024 · While local laws of Singapore, Malaysia and Indonesia have fully complied with the ASEAN Medical Device Directive, it is encouraging to see more developments of various Member States in ASEAN this year. From the report of the 8th ASEAN Medical Device Committee Meeting and Related Activities – Industry Training Sessions and …

Thailand Implements New Medical Device Regulations

WebUnder Thai law, the definition of a medical device is largely harmonised with international standards. ... (CSDT) as outlined in the Association of Southeast Asian Nations (ASEAN) Medical Device Directive (AMDD)5, needs to be submitted along with the government fee of THB 20,100 (approximately US$ 670) or THB 10,100 (approximately US$ 337) for ... WebJun 9, 2024 · On June 20, 2024, the TFDA released an updated announcement outlining the expansion of the Singapore Reliance Route program. This program, initially piloted with only Class D/Class 4 products, is now open to all Class B, C, and D medical devices. To qualify, the product must be approved and actively listed on the Singapore Medical Device ... how contagious is poison oak

Thailand IVD Device Registration and Approval Asia Actual, LLC

WebFeb 26, 2024 · This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2024) (Issue 2) with the ASEAN Medical Devices Directive. ... Class 2, 3, and 4 application will need to … WebAll devices registered in Thailand after February 15, 2024, shall comply with the new medical device regulations and shall have their technical files compiled in the CSDT format. The devices currently approved under the old regulations shall be renewed as per the new Thai medical device regulations. WebThailand’s medical device registration is managed by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (FDA). The regulatory process is based on the Medical Device Act B.E. 2551 (2008) and updated by the Medical Device Act/Ordinance B.E. 2562 (2024) (Issue 2). New regulations recently went into effect on ... how many powerlifting federations are there