• 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 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.

• 2020-11-26 10:42:10

The German-based “Society for Promotion of East West Knowledge Transfer” had invited the experts of Qualtech to share their knowledge on the Taiwan registration processes for medical devices and pharmaceutical products to a number of high-ranking and selected attendees. Within a 90-minute session held on November 10th, Qualtech guided participants through the different Taiwan certification procedures and further elaborated on the clinical requirements in place for pharmaceuticals.

• 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

• 2020-11-26 10:42:10

Food and Drug Administration has arranged and announced a set of documentation required for Seller's License renewal that will expire on December 31st, 2020. Seller’s Licensee shall refer to this license renewal statement letter and prepare documents accordingly to prevent any mistakes while submitting leading to an efficient submission.

• 2020-11-26 10:42:10

The EUDAMED actor registration module will be available starting December 2020. All the economic operators should request single registration number (SRN) through this module, including manufacturers, authorized representatives, system/procedure pack producers, and importers.