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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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歐盟醫療器材法規概要與發展

歐盟醫療器材法規概要與發展

  • 2021-01-08 02:18:25

2021/1/13 (三) 16:00 (GMT+8),我們很榮幸邀請到Mr. Arkan Zwick (Regulatory Affairs Director of Croma) 與Ms. Alexandra Baer-Zwick (Head of RA-GCD, deputy QPPV of Croma) 為我們分享歐盟醫療器材法規概要與發展。

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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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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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