WebNov 24, 2024 · 3) Licensed Medical Device Import Permit: 20,000. 4) Notified Medical Device Manufacturing License: 5,000. 5) Notified Medical Device Import Permit: 10,000. 5. Duration and place to apply for renewal. The renewals can be made from 1 October 2024 – 31 December 2024 via Skynet. The late Renewal application shall not exceed 30 … 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 ...
TFDA Updates Review Timelines for Medical Device Applications
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 ... WebMay 17, 2024 · Medical devices in Thailand are generally regulated under the Medical Devices Act B.E. 2551 (2008) (the " Medical Devices Act "). The Medical Devices Act includes 3 broad categories of medical ... new start cat rescue gloucestershire
Medical Device Registration in Thailand - CMS MedTech
WebFeb 11, 2024 · Upcoming changes to the above medical device regulations. The new regulations will be promulgated in the near future (expected publication date in mid-February 2024) in order to align with the ASEAN … 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 … WebThailand Life Sciences; Thai Clinical Trials Registry (TCTR) CSDT e-Learning. CSDT e-Learning; Database of Essential Principle (Eps) and National Quality Infrastructure (NQI) for Medical Devices ; E-Document … new start cat rescue facebook