• 2021-01-08 02:18:25

2021/1/13 (三) 16:00 (GMT+8)，我們很榮幸邀請到Mr. Arkan Zwick (Regulatory Affairs Director of Croma) 與Ms. Alexandra Baer-Zwick (Head of RA-GCD, deputy QPPV of Croma) 為我們分享歐盟醫療器材法規概要與發展。

• 2020-12-24 11:05:44

TFDA has announced a new draft about Good Distribution Practice (GDP). This practice requires distributors who import and/or sell medical devices or who hold medical device registration licenses (license holders) to set up a good distribution system. This is to ensure their quality and integrity are constantly maintained. In this article we have listed important points for distributors to comply with the GDP guideline, throughout the process of importation, transportation, storage, sale and post-market services competent authority and obtaining a distribution license.

• 2020-12-24 11:09:03

Health Sciences Authority (HSA) – Medical Devices Branch had organized a webinar regarding an introduction to Medical Device Unique Device Identification (UDI) System last October 19, 2020. In addition, the webinar includes the phased implementation plan for UDI in Singapore.

• 2020-12-24 11:02:25

Thai FDA is committed to ensuring utmost standard, quality and safety of medical devices marketed in Thailand is consistently kept. Hence, they have announced a new medical device complaint channel, complaint record and management system for inspection. This decree is beneficial in providing assurance to consumer regarding safety and prevention of comparable adverse event in the future.

• 2020-12-24 10:59:21

In the past Thai FDA had perpetually notified manufacturers / importer / distributors regarding the acute adverse effect of powdered surgical gloves to end-users or patients. Now, the Thai FDA has officially announced the prohibition of manufacturing, importation or sale of powdered surgical gloves, to ensure safety control to end-users or patients and prevention of adverse effect from the use of powdered surgical gloves.

• 2020-12-24 10:54:11

Thai FDA has recently announced a list of standards to be complied by disposable surgical masks, upon making a set of COVID-19 related medical devices announcement.

• 2020-12-24 02:53:02

A person who wishes to advertise a medical device in Thailand must obtain a medical device advertising license upon any medical devices marketing activity. Thai FDA had published further advertising announcement regarding the advertising specifications of medical devices that are exempted to proceed advertising license registration to conveniently advertise medical devices.

• 2020-12-24 01:55:33

Ministry of Public Health has introduced a new guidance document regarding labelling of medical devices to be registered and sold in Thailand. This is to ensure consumers safety, as well as distributing accurate and sufficient medical device information.

• 2020-12-24 01:44:02

Ministry of Public Health has announced that direct advertising to medical and public health practitioner are exempted from applying for advertising license,  for the convenience in advertising medical devices.

• 2020-12-23 07:24:48

The Ministry of Health has been issued a decree No. 117/2020/ND-CP dated September 28, 2020 on prescribing penalties for administrative violations in medical sector, effective from November 15, 2020.