• 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.

• 2020-12-23 07:22:04

The Ministry of Health has issued Directive No. 20/CT-BYT dated October 1, 2020 on strengthening bidding to ensure competition, openness, transparency and efficiency in the health sector.

• 2020-12-23 07:07:34

The Vietnam Ministry of Health has issued Circular No. 14/2020/TT-BYT dated 10 July 2020 (“Circular No. 14“), which regulates various aspects of the bidding process of medical devices for public health establishments. This circular took effect on 1 September 2020.

• 2020-12-23 02:21:33

MDA has announced a new search database, Medical Device Authority Register (MDAR).

• 2020-12-23 02:15:03

MDA has come up with a new guidance document incorporating the 2019 published Medical Device Advertisement Regulation.

• 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.