• 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.

• 2020-11-27 02:07:10

This announcement applies to all registrants of foreign Class II and Class III medical devices that have been registered in China, through foreign manufacturers established in China.

• 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.

• 2020-11-26 10:29:19

PFDA launched a verification portal where interested parties and prospective clients can check list of registered products and firms.

• 2020-11-26 10:19:14

Japan has introduced a set of changes, aiming to market innovative products as fast as possible to help patients in Japan with deadly diseases. One of the changes implemented is Fast-Track Approval Scheme.