On November 10, 2017, Philippine Food and Drug Administration (FDA) announced that the technical review and reevaluation process of 51 contraceptives products covered by a resolution issued by the Supreme Court – the highest court and judiciary power in the Philippines, has been completed.
More A new Circular Letter was released by Medical Device Authority (MDA) on October 2, 2017, in which MDA recognizes Institute of Medical Research (IMR) Malaysia as a credible source to provide clinical evaluation data for conformity assessment purposes conducted by a Conformity Assessment Bodies (CAB) in Malaysia. This Circular Letter comes into effect starting October 2, 2017.
More On 13 November 2017, Medical Device Authority (MDA) released the Medical Device (Declaration) Order 2017, which comes into operation on 1st of January, 2018. In this order, the MDA declares “Non-Corrective Contact Lenses”, also commercially known as “Cosmetic Contact Lenses”, as legitimate medical device.
More 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.
More 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.
More 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.
More 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
More
The Government of India notified in February 2017 the new Medical Device Rules 2017, which will come into force starting January 1, 2018. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.
MoreWe collect your browsing history through cookies to understand how you use our website to analyze and improve your experience. By continuing to use our website, you accept our use of cookies.
