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QT ANALYSIS: Hong Kong Medical Devices Market and Registration Overview

QT ANALYSIS: Hong Kong Medical Devices Market and Registration Overview

  • 2021-01-19 02:59:53

Hong Kong boasts a wealthy and sophisticated medical device market. 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 booming medical device market in Asia and how you shouldn’t miss out on the great business opportunities it offers.

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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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INDONESIA: The National Public Procurement Agency Open E-katalog Registration for Domestic and COVID-19 related Medical Devices – Oct, 2020

INDONESIA: The National Public Procurement Agency Open E-katalog Registration for Domestic and COVID-19 related Medical Devices – Oct, 2020

  • 2020-11-26 03:47:29

In 2020, National Public Procurement Agency (in Indonesia known as LKPP) has opened E-katalog registration for domestic medical device products and several medical products for handling Covid-19. Due to the Covid-19 pandemic, there are several stages in the E-katalog registration process which is carried out online, namely verification / clarification process. However, the price negotiation stage is still carried out face to face. There is also a possibility that e-katalog registration for imported medical products will be opened around this year.

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THAILAND: Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Notified Registration – September, 2020

THAILAND: Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Notified Registration – September, 2020

  • 2020-09-15 08:44:25

Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.

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THAILAND: Thai FDA announce that manufacturer and importer must proceed medical device to be licensed registration 2020 – June, 2020

THAILAND: Thai FDA announce that manufacturer and importer must proceed medical device to be licensed registration 2020 – June, 2020

  • 0000-00-00 00:00:00

Despite the effect of COVID-19 outbreak, ThaiFDA continued to perform at its best for the Medical device regulation reform update. Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Thai FDA Announced that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration.

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THAILAND: Ministry of public health announce that manufacturer and importer must proceed medical device to be notified registration 2020 – May, 2020

THAILAND: Ministry of public health announce that manufacturer and importer must proceed medical device to be notified registration 2020 – May, 2020

  • 2020-05-12 08:17:52

Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020, in order to gradually promote the transition of Thailand future regulation implementation.

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THAILAND: ThaiFDA announcement regarding required documents for medical device related to COVID-19 registration - May, 2020

THAILAND: ThaiFDA announcement regarding required documents for medical device related to COVID-19 registration - May, 2020

  • 2020-05-12 06:28:19

Although Thailand has decreased the numbers of infections significantly yet to relieve since the disease is very contagious. Food and Drug Administration is decidedly in concern that Thailand shall have enough resources in hands to dispute this COVID-19 Outbreak via the Fast Track option developed by ThaiFDA for manufacturer and importer of COVID-19 related products.

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