June Newsletter 2024 – Simplified Chinese
我们期待在六月时事通讯中分享最新的更新和见解。里面是什么！ ！有关医疗器械法规和合规性的最新信息化妆品安全标准及行业趋势深入了解药品审批和市场新闻请阅读下面的更多信息。June Newsletter Chinese (Simplified)...
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June Newsletter 2024 – Chinese (Traditional)
我們期待在六月時事通訊中分享最新的更新和見解。裡面是什麼！ ！有關醫療器械法規和合規性的最新信息化妝品安全標準及產業趨勢深入了解藥品審批和市場新聞請閱讀下面的更多資訊。June Newsletter Chinese (Traditional)...
June Newsletter 2024
We’re excited to share the latest updates and insights in our June newsletter! What’s Inside!! Read detailed information below: https://omcmedical.com/wp-content/uploads/2024/07/June-Newsletter-2024-English.pdf...
Symbols used in Labelling
There are multiple symbols used in labelling, but what are the harmonised standards that are internationally accredited. ISO 15223-1: 2021 – Medical Device Symbols released in July 2021 provides standardised symbols recognised by the international community. European union has harmonised this under the MDR and has allowed a transition period of March 2022. However, FDA still hasn’t approved this but the previous version ISO 15223-1:2016 is approved by FDA. Some symbols that are not standardi...
Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
TFDA Requirements for Summary Product Characteristic (SPC) Thailand, governed by the Drug Act B.E.2510. The key points are as follows 1. Legal Basis and Scope Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA). Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical infor...
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