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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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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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What's New in Line for the ASEAN Medical Device Regulations in 2022 – November, 2021

What's New in Line for the ASEAN Medical Device Regulations in 2022 – November, 2021

  • 2021-11-24 10:36:48

2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies. When these come into full implementation in 2022, stakeholders need to be well-equipped to face them and prepare a contingency plan to adopt them for the medical devices already in the market. In this article, we shall take a look at the regulations to be fully implemented starting 2022 in Malaysia, Singapore, Indonesia, Thailand, Vietnam and Philippines.

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