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Qualtech ANALYSIS: The Benefits of Assigning a Neutral 3rd Party as Your Local License Holder AND a Summary of the Product Registration License Conditions in ASEAN, East Asia, and Australia – February, 2022

Qualtech ANALYSIS: The Benefits of Assigning a Neutral 3rd Party as Your Local License Holder AND a Summary of the Product Registration License Conditions in ASEAN, East Asia, and Australia – February, 2022

  • 2022-02-18 07:20:17

As 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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QT ANALYSIS: Artificial intelligence Based Software Registration in ASEAN – November, 2020

QT ANALYSIS: Artificial intelligence Based Software Registration in ASEAN – November, 2020

  • 2020-11-26 10:42:10

AI based SaMD is getting more traction in ASEAN counties, owing to their huge potential to transform healthcare industry. At the same time, local regulatory bodies are getting stricter in the evaluation of these AI based SaMD, for added safety and ensuring smooth performance. In this issue of QT Analysis, we are looking into the requirements for registering and marketing these AI based SaMD in selected ASEAN countries.

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