News

Seminar by TFDA: China GCP Experience Sharing - July 2018

Seminar by TFDA: China GCP Experience Sharing - July 2018

  • 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.

More
 "Foreign Special Case Recognition Policy" Enables Foreign Medical Device Factory to Obtain Express Pass - June 2018

"Foreign Special Case Recognition Policy" Enables Foreign Medical Device Factory to Obtain Express Pass - June 2018

  • 2020-02-14 04:21:46

A research conducted by BMI Espicom showed that the scale of the global medical device market is expected to reach US$38.91 billion in 2019, of which Japan has the world’s second largest medical device market, second to United States. Global medical equipment manufacturers in addition to Europe and the United States well-known manufacturers (GE, Medtronic, Johnson & Johnson, etc.),

More
CHINA: Further Notice from the Hainan Government on “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area” – June 2018

CHINA: Further Notice from the Hainan Government on “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area” – June 2018

  • 2020-02-14 04:17:45

During the early week in May, the Hainan Government has issued a further notice for “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. This is applicable to medical devices that are urgently needed for clinical purposes (hereinafter referred to as "emergency devices").

More