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MALAYSIA: New Procedure for Medical Device Re-registration – June/July 2025

MALAYSIA: New Procedure for Medical Device Re-registration – June/July 2025

  • 2025-07-10 10:12:51

Malaysia Medical Device Authority (MDA) has announced that the re-registration function will be made available in the upgraded MeDC@St 2.0+ system exactly one year before the expiration date of the registration certificate. The implementation helps establishment in better planning and managing device re-registration and change notification in advance.

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MALAYSIA : Updated in Harmonised Borderline Products in ASEAN (MDA/GD/0063) and Harmonised Classification of Medical Devices in ASEAN (MDA/GD/0062) – June/July 2025

MALAYSIA : Updated in Harmonised Borderline Products in ASEAN (MDA/GD/0063) and Harmonised Classification of Medical Devices in ASEAN (MDA/GD/0062) – June/July 2025

  • 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

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Singapore: Introducing "SHARE" – Singapore Health Product Access and Regulatory E-System for Medical Device – June/July 2025

Singapore: Introducing "SHARE" – Singapore Health Product Access and Regulatory E-System for Medical Device – June/July 2025

  • 2025-07-10 09:14:07

The Health Science Agency (HSA) are pleased to announce the launch of SHARE (Singapore Health Product Access and Regulatory E-System). This new system will replace the existing MEDICS system for medical device product registrations and license submissions.
SHARE was first time introduced to the stakeholders during an Industry Briefing on May 21, 2025. During the session, HSA highlighted key changes implemented for medical devices on SHARE, demonstrated the user interface and key features, and outlined the timeline for the full transition from MEDICS to SHARE, effective July 14, 2025.

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Qualtech Webinar: Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial – July 2025

Qualtech Webinar: Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial – July 2025

  • 2025-07-07 08:26:29

Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.

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QT ACTIVITY: NAVIGATING INDIA'S MEDICAL DEVICE REGULATORY LANDSCAPE WEBINAR RECAP - MAY/JUNE 2025

QT ACTIVITY: NAVIGATING INDIA'S MEDICAL DEVICE REGULATORY LANDSCAPE WEBINAR RECAP - MAY/JUNE 2025

  • 2025-06-03 07:01:37

On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India's regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.

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Thailand: Where Healthcare Meets Tourism - MAY/JUNE 2025

Thailand: Where Healthcare Meets Tourism - MAY/JUNE 2025

  • 2025-06-03 06:29:29

Thailand's medical tourism industry offers a unique blend of affordable, high-quality healthcare and a captivating tourist experience. Patients worldwide are attracted by the diverse range of medical specialties, advanced technology, and international accreditation of Thai medical facilities. The country's growing demand for medical devices and supportive government policies further solidify its position as a leading medical tourism destination.

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MALAYSIA: MDA Issue New Guidance Document on Importation of Medical Device for Re-Export (IRE) – May/June 2025

MALAYSIA: MDA Issue New Guidance Document on Importation of Medical Device for Re-Export (IRE) – May/June 2025

  • 2025-05-29 09:42:50

Malaysia Medical Device Authority (MDA) authority issues the new guidance documents of Importation of Medical Device for Re-export (IRE), MDA/GD/0069 in March 2025. This guidance document outlines the procedure for importing medical devices into Malaysia for re-export purposes. It is particularly beneficial for importers and manufacturers by providing clear regulatory steps, approval requirements, and compliance guidelines to facilitate smooth procedure.

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