• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations of the Medical Device Quality Management System. This article provides a comparison between the current and the upcoming regulation.

• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations on Good Clinical Practice for Medical Devices”. This article provides a comparison between the current specification and the upcoming regulation.

• 2020-06-16 05:48:04

This is a specific pre-clinical testing guidance for products classified under Soft (hydrophilic) contact lens in Taiwan. The guidance provided a clear standard of (1) product description and specification, and (2) safety and performance data.

• 2020-06-16 05:36:31

This is a specific pre-clinical testing guidance for products classified under Powered wheelchair in Taiwan. The guidance provided a clear standard of (1) product description and specification, and (2) safety and performance data. The overall pre-clinical test data should include inspection specifications, methods, original records, and results.

• 2020-06-16 05:19:05

To ensure the safety and efficiency of adopting human factors/usability engineering evaluation while manufacturer developing medical devices, this guidance provided an overall concept and guide, including product design, development, registration, and post-market related matters.

• 2020-05-14 09:43:07

The online event represents the second webinar in our 2020 series and will be held on June 17th, 2020 (Wednesday) at 11am (GMT+8). Shall this Webinar be of interest to you or one of your colleagues, please be sure to register under the following link (limited seats available).

• 2020-02-21 07:27:21

January 8th, 2020 has marked the day of Qualtech’s extensive workshop on the new European Medical Device Regulations (MDR) for its Taiwanese clients. The event provided its attendees with the latest updates on the MDR implementation before the end of the transition period on May 26, 2020.

• 2020-02-21 07:24:35

Qualtech’s Taipei Office was awarded with the Certificate of Excellence for its Good Distribution Practice in Taiwan by the TFDA.

• 2020-02-21 07:09:30

The Taiwan Council passed the draft of the " Regulations of Medical Devices" (hereafter simply referred to as the “Regulation”) in December 2019. The regulation has medical devices to be legislated independently and thus no longer fall under the Pharmaceutical Affairs Act.

• 2020-02-12 13:54:20

On December 7th 2018, TFDA has formally announced that Japanese manufacturers may take a QSD simplified route of application.