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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: "Double Agent" Scenario in Indonesia

INDONESIA: "Double Agent" Scenario in Indonesia

  • 2021-01-19 03:20:16

Indonesia's Ministry of Health has explained about the scenario of "Double Agent" at a seminar that was held recently. "Double Agent" is the term used to refer multiple authorizations for the one product brand originated from the same Principal or Manufacturer to the several Medical Device Distributors.

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European MDR Online Training

European MDR Online Training

  • 2021-01-08 02:18:25

We have European MDR Online Training with Croma – Director of Regulatory Affairs Mr. Arkan Zwick and Head of RA-GCD, deputy QPPV at Croma Ms. Alexandra Baer

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QT ANALYSIS: New GDPMD Regulation in Taiwan

QT ANALYSIS: New GDPMD Regulation in Taiwan

  • 2020-12-24 11:05:44

TFDA has announced a new draft about Good Distribution Practice (GDP). This practice requires distributors who import and/or sell medical devices or who hold medical device registration licenses (license holders) to set up a good distribution system. This is to ensure their quality and integrity are constantly maintained. In this article we have listed important points for distributors to comply with the GDP guideline, throughout the process of importation, transportation, storage, sale and post-market services competent authority and obtaining a distribution license.

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SINGAPORE: HSA Shares Future Plan of UDI System in Singapore

SINGAPORE: HSA Shares Future Plan of UDI System in Singapore

  • 2020-12-24 11:09:03

Health Sciences Authority (HSA) – Medical Devices Branch had organized a webinar regarding an introduction to Medical Device Unique Device Identification (UDI) System last October 19, 2020. In addition, the webinar includes the phased implementation plan for UDI in Singapore.

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THAILAND: Introduction of New Medical Device Complaint Channel, Complaint Record and Management System for Inspection

THAILAND: Introduction of New Medical Device Complaint Channel, Complaint Record and Management System for Inspection

  • 2020-12-24 11:02:25

Thai FDA is committed to ensuring utmost standard, quality and safety of medical devices marketed in Thailand is consistently kept. Hence, they have announced a new medical device complaint channel, complaint record and management system for inspection. This decree is beneficial in providing assurance to consumer regarding safety and prevention of comparable adverse event in the future.

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