• 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.

• 2020-02-21 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.

• 2020-02-13 06:12:14

Taiwan Food and Drug Administration(TFDA) is organizing an upcoming seminar in end of July (July 20th, 2018) in Taoyuan (Taiwan), and Qualtech has been invited to share our GCP experience in China. This seminar will discuss the GCP inspection of medical devices in various oversea countries and how to conduct a multicenter clinical trial in various countries.

• 2020-02-14 04:23:23

TFDA Department of Medical Device and Cosmetics is set to move to a new office starting on April 30, 2018. The new office will be located at the Alley 12, 2nd Section of Yan Jiu Yuan Road, Nangang District, Taipei City.

• 2020-02-15 06:16:53

n order to ensure that the 3D printing production of medical equipment is scientific, safe and effective, and to uphold consumer protection, the Taiwanese Food and Drug Administration (TFDA) commissioned the national Cheng Kung University to develop a draft of "the product management guideline for 3D printing medical device,” which is applicable to medical devices which use 3D printing technology in their manufacturing process.

• 2020-02-15 07:38:53

With a solid business foundation dating back to 1968, TÜV SÜD Japan was established in 1993 to meet the increasing demand for enhanced quality and safety testing and certification in the Japanese market.

• 2020-02-15 07:51:32

The Asia Regulatory Professional Association (ARPA) is an organization of Healthcare Regulatory Affairs professionals in Asia. ARPA aims to raise the standard and social recognition of Regulatory Professionals as part of Healthcare team. QT has the honor to invite ARPA to the conference in Taipei Technology University every year.

• 2020-02-15 09:10:35

Qualtech TFDA manager is invited to be the speaker in Singapore seminar "Understanding Taiwan's Regulatory Framework for Medical Devices" organized by Singapore Manufacturing Federation and DH RegSys Pte Ltd.

• 2020-02-15 08:44:50

On 25 June & 26 June, 2013, Qualtech TFDA manager, Juliana Chang, was invited by  Singapore Manufacturing Federation and DH RegSys Pte Ltd to give the TFDA training in Singapore.