• 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.

• 2020-12-23 01:29:16

Certificate of Medical Device Notification (CMDN) is now required to process the customs release of PPEs in addition to the LTO of the importer.

• 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.

• 2020-11-26 10:42:10

AI based SaMD is getting more traction in ASEAN counties, owing to their huge potential to transform healthcare industry. At the same time, local regulatory bodies are getting stricter in the evaluation of these AI based SaMD, for added safety and ensuring smooth performance. In this issue of QT Analysis, we are looking into the requirements for registering and marketing these AI based SaMD in selected ASEAN countries.

• 2020-11-27 02:19:08

Compared to domestic and foreign listed products, novel medical devices with new designs, materials or processes, or scope of application and pose a high risk to humans should be approved for clinical trials before the trials can be conducted in China.

• 2020-11-27 02:14:19

From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices.