• 2020-02-14 15:22:02

The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.

• 2020-02-15 06:22:45

According to the “Regulations for the Supervision and Administration of Medical Devices,” "Provisions for Medical Device Registration,” “Provisions for In-vitro Diagnostic Reagent Registration,” and “Provisions for Instructions and Labels of Medical Devices,” when applying for medical device listing in China, the applicant name shall be in Chinese.

• 2020-02-14 15:26:51

• 2020-02-15 06:39:56

China Food and Drug Administration (CFDA) is planning to require foreign registrants to provide its company information in Chinese, such as company name and addresses.

• 2020-02-15 06:38:07

he conference began with Qualtech's Global Manager Irene Lu explaining the regulation changes in ASEAN countries and shared Qualtech's registration experiences in the local countries. Then, MedNet CEO, Mr. David Thaler, shared the responsibilities and obligations of EU representatives under the implementation of the new MDR.

• 2020-02-15 06:37:05

Last August 11th 2017, Professor Toshia Fujisato and Professor Ashitaka Emiko from Osaka Istitute of Technology visited Qualtech Taipei Headquarters with Professor ke-shao Chen and his wife from Tatung University. There was an exchange of practical medical device industry experiences between the Professors and Qualtech members.

• 2020-02-15 06:36:09

On August 25th 2017, Professor Xi Ting-fei from Peking University visited Qualtech Taipei Headquarters. Professor Xi Ting-fei is the director of Biomedical Material and Tissue Engineering Research Center of Academy for Advanced Interdisciplinary Studies, Peking University.

• 2020-02-15 06:35:05

   Last August 1, 2017, in line with Qualtech bringing its services closer to clients, a business office was opened in Japan. The new office offers medical device regulatory research and consultancy for product registraiton, local representation and clinical trial services in China, Taiwan and ASEAN to our Japanese clients

• 2020-02-15 06:44:25

• 2020-02-15 06:49:44

Qualtech will be celebrating the festival and sharing joy and valuable times with families and friends.