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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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[QT Analysis] Singapore: Gateway to ASEAN Healthcare Opportunities – September, 2020

[QT Analysis] Singapore: Gateway to ASEAN Healthcare Opportunities – September, 2020

  • 2020-09-15 06:44:21

Singapore remains one of the most important medical device hubs in the Asian region, growing to be on par with developed first world nations. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a MedTech Giant in Asia and how you shouldn’t miss out on the great business opportunities it offers.

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PHILIPPINES: PFDA amends administrative order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” – July, 2019

PHILIPPINES: PFDA amends administrative order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” – July, 2019

  • 2020-05-06 09:31:48

PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.

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