• 2020-11-26 01:31:52

Thailand is currently gearing up a step closer toward the transition of Thailand future regulation from Policy – based Classification to Risk-based Classification as Thailand’s Food and Drug Administration announced that it is mandatory for importer to prepare Technical Documents (CDST Dossier) upon importation by the period as follows : 1) Class 1, 2 and 3: 13 June 2021. 2) Class 4: 11 September 2021. Licensee who fails to comply with ThaiFDA must be sentence to penalty condition is as follows:
1. Licensed and Notified Medical Device: Shall be liable to imprisonment for a term not exceeding 1 year or fine not exceeding 100,000 THB or both.
2. General Medical Device: Shall be liable to imprisonment for a term not exceeding 6 months or fine not exceeding 50,000 THB or both.

• 2020-10-30 09:18:20

隨著科技的日新月異，改善醫療品質及解決臨床問題儼然成為人們追求健康的一項目標。

• 2020-10-28 02:13:28

With Overseas Medical Equipment Technical Assistants (OMETA), Qualteh has held an online seminar about regulatory updates in ASEAN on 27th October, where we covered major updates in the Philippines, Thailand, and Malaysia.

• 2020-10-28 02:13:28

於2020/11/11(三)至2020/11/12 (四) 09:00-17:30 (GMT+8)期間，我們很榮幸邀請到台北醫學大學牙醫學系的張維仁教授為我們分享數位牙科植體的資訊與課程。

• 2020-11-09 10:51:43

Post-market surveillance has become an inexorable trend around the globe.
Therefore, proactively collect and track the following information of your products is essential and crucial.
-Relative post-market incidents reported (e.g. alerts, AEs, recalls)
-Relevant clinical literatures

• 2020-10-27 06:10:24

很高興跟大家分享理工科技受邀Europe-Taiwan Biotech Association 和 Society for Promotion of East West Knowledge Transfer，將於2020年11月10日在國際上的線上會議分享醫療器材的註冊要點。

• 2020-10-29 05:46:11

Qualtech已開始為瞄準日本市場的醫療設備製造商提供監管服務。 藉此機會，我們將簡要介紹日本法規對外國製造商在其市場上銷售其產品的要求。

• 2020-10-21 02:06:33

CDSCO已發布了針對以前未通知的通用和IVD醫療設備的新的基於風險的分類列表草案，以闡明監管途徑和要求。

• 2020-10-21 01:59:48

馬來西亞醫療器械管理局（MDA）發布了有關醫療器械翻新政策實施和執行的新通函，並立即生效。 確保翻新醫療設備本身的安全性和有效性的政策決定。

• 2020-10-21 01:42:37

美國食品藥品監督管理局緊急宣布了針對手術用粉末手套的某些控制措施，這些措施涉及製造過程中所用粉末的技術問題，可能會對最終用戶或患者造成嚴重不利影響。