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MALAYSIA: MDA/GD/0067: POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES – MARCH/APRIL 2024

MALAYSIA: MDA/GD/0067: POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES – MARCH/APRIL 2024

  • 2024-04-03 09:34:09

The Medical Device Authority (MDA) published new Guidance Document, on “POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES”, on January, 2024. This document serves as guidance on exchange of post market information among AMS.
In order to maintain patient safety and public health, it is necessary that all medical devices that are placed in the market meet appropriate standards of safety, quality and performance, and that they are used safely.

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MALAYSIA: Harmonised Borderline Product in ASEAN  – January/February 2024

MALAYSIA: Harmonised Borderline Product in ASEAN – January/February 2024

  • 2024-01-26 05:18:26

The Medical Device Authority (MDA) published a second edition guidance document on “Guidance on Harmonised Borderline Product in ASEAN" on December 23, 2023. This guidance document provides a list of borderline products, whether they are medical devices or non-medical devices, based on their intended purpose as claimed by the manufacturer, which is harmonised in ASEAN. This guidance document will be updated on a yearly basis to reflect the latest decisions of the ASEAN Medical Device Committee (AMDC).

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MALAYSIA: Harmonised Classification of Medical Device in ASEAN. –January/February 2024

MALAYSIA: Harmonised Classification of Medical Device in ASEAN. –January/February 2024

  • 2024-01-26 05:03:01

The Medical Device Authority (MDA) published Second edition Guidance Document, on “Guidance on Harmonised Classification of Medical Device in ASEAN”, on December 12, 2023. This guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer.

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QT ACTIVITY: QUALTECH DRIVES GROWTH IN THE ASEAN REGION THROUGH TRANSFORMATIVE BUSINESS DEVELOPMENT MEETING  - DECEMBER/JANUARY 2024

QT ACTIVITY: QUALTECH DRIVES GROWTH IN THE ASEAN REGION THROUGH TRANSFORMATIVE BUSINESS DEVELOPMENT MEETING - DECEMBER/JANUARY 2024

  • 2023-12-26 05:15:49

Qualtech's regional meeting united leaders from across ASEAN to collaborate, share knowledge, and shape the future of Qualtech in the region. The event focused on fostering unity, unwavering commitment to quality with ISO 13485 standards, and strategic planning for each country's unique needs. A cultural immersion tour of Chulalongkorn University provided inspiration and deeper understanding. The meeting concluded with a shared vision for the future of Qualtech in ASEAN.

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QT ANALYSIS: A Summary of the Regulatory Updates in the ASEAN Markets as Based on Qualtech's ASEAN Webinar – May/June 2023

QT ANALYSIS: A Summary of the Regulatory Updates in the ASEAN Markets as Based on Qualtech's ASEAN Webinar – May/June 2023

  • 2023-05-24 07:33:47

Qualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.

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QT 活動: Qualtech將於 2023 年 4 月 28 日星期五舉行ASEAN法規更新網絡研討會

QT 活動: Qualtech將於 2023 年 4 月 28 日星期五舉行ASEAN法規更新網絡研討會

  • 2023-03-29 10:01:23

您是不是正在找尋一條進入各個亞洲市場的通路?
是不是想要簡單明瞭地取得各個東協國家之間的法規差異?
您是否有留意到東協醫療器材指令(ASEAN Medical Device Directive)將在進入多個東協國家之前予以簡化審查流程的機會?
想要了解更多、更廣、更全面的東協國家法規與市場資訊嗎?一同加入Qualtech的東協法規更新的線上研討會吧!研討會預計將於2023年4月28日下午4:00至5:30舉行,俗話說機會是留給有準備的人,所以,別錯過這次的精彩活動!

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Qualtech ANALYSIS: The Benefits of Assigning a Neutral 3rd Party as Your Local License Holder AND a Summary of the Product Registration License Conditions in ASEAN, East Asia, and Australia – February, 2022

Qualtech ANALYSIS: The Benefits of Assigning a Neutral 3rd Party as Your Local License Holder AND a Summary of the Product Registration License Conditions in ASEAN, East Asia, and Australia – February, 2022

  • 2022-02-18 07:20:17

As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.

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