SOCIAL RESPONSIBILITY: EMPOWERING FUTURE INNOVATORS [QUALTECH'S INTERNSHIP PROGRAM WITH TAIPEI MEDICAL UNIVERSITY]
- 2023-07-24 10:42:16
Congratulations to our first PhD internship program candidate!! Graduating with PhD degree!
MoreCongratulations to our first PhD internship program candidate!! Graduating with PhD degree!
MoreQualtech is excited to invite you to an insightful webinar: Asia's Business Frontier: Korea Market Expansion & China Registration Service Updates!
MoreQualtech hosted a talk by Dr. Huang Wen-Chien on the evolution of minimally invasive lung cancer treatment. The advancements discussed included surgical tools, non-surgical techniques, and video-assistive technology. Qualtech also offers comprehensive Clinical Evaluation Report (CER) services to assist with medical device registration, drawing upon expertise in biomedical engineering and molecular biology to deliver high-quality reports for various regions.
MoreQualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.
MoreIf you would like to know more about these aspects and many more important regulatory information for the ASEAN markets, you may join Qualtech's ASEAN Regulation Update Webinar on 28 April 2023 (Friday) at 16:00 p.m. – 17:30 p.m. (GMT+8).
MoreQualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.
MoreQualtech's internal Southeast Asia regulatory training and our End of the Year Party 2022 have been successfully completed. As the borders have gradually reopened and travel restrictions have been lifted, Qualtech has invited its members from the various ASEAN countries as well as from Japan to gather in our headquarter in Taipei. The accomplishments of the gathering include the exchange of regulatory information, the fostering of better communication, and the strengthening of our teamwork across the various Qualtech branch offices.
MoreQualtech introduced medical device regulations and the role of authorized representative in ASEAN in the seminar held by Tokyo University's association, which supports medical device innovation.
MoreThe OMETA/Qualtech Webinar 2022 was held on September 29, featuring updates on regulations in Asia.
MoreAs Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.
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