• 2021-02-22 02:35:59

Taiwan FDA has announced a Product Registration Guidance for Artificial Intelligent/Machine Learning based Software Medical Device, or so-called AI/ML-Based SaMD. The guidance provides overall requirements and forethoughts for manufacturers to consider and describe when designing and establishing the products.

• 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 10:54:11

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.

• 2020-12-23 02:01:32

TFDA has recently announced a 3-stage schedule of implementing UDI system on labels of medical devices. Starting from June 1st, 2021, class 3 implantable medical devices are the first round of products that are required to comply with this regulation; followed by class 3 non-implantable medical devices starting from June 1st, 2022, and finally, class 2 medical devices starting from June 1st, 2023.

• 2020-12-23 01:53:56

To further develop a more practical and effective safety surveillance system, TFDA has set up regulations of serious adverse event reporting especially for medical devices. This article leads you into the main differences of the current and upcoming regulations.

• 2020-10-19 09:48:24

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

• 2020-09-15 08:58:35

Thailand’s Ministry of Public Health has announced the medical devices that are exempted form compliance with certain control measures under Section 6 (18) of the Medical Device Act B.E. 2551.

• 2020-09-15 08:54:58

Ministry of Public Health has made an announcement regarding the Declaration Form for Importer to declare when import all the listed medical device that comply with the standards in 2020.