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China: Notice on Registration of Medical Device Technical Dossier–May, 2021

China: Notice on Registration of Medical Device Technical Dossier–May, 2021

  • 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

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QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

  • 2021-02-19 09:51:48

Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.

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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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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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