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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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MALAYSIA: MDA ANNOUNCED MANDATORY PROBLEM REPORTING REQUIREMENTS UNDER ACT 737 AND RULE 2019 − OCTOBER/NOVEMBER 2023

MALAYSIA: MDA ANNOUNCED MANDATORY PROBLEM REPORTING REQUIREMENTS UNDER ACT 737 AND RULE 2019 − OCTOBER/NOVEMBER 2023

  • 2023-10-20 06:51:30

The Medical Device Authority (MDA) announced on 19th September that any event involving registered medical devices that occurs outside of the country is not required to be reported to MDA if the incident has been notified to the regulatory agency in the country where the incident happened and corrective action or precautions have been taken by the manufacturer or establishment.

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MALAYSIA: MDA ANNOUNCED TRANSITION PERIOD OF REGISTRATION APPLICATION WITH EXEMPTION FROM COMPLIANCE ASSESSMENT PROCESS BY COMPLIANCE ASSESSMENT BODY (CAB) FOR REGISTRATION OF COVID-19 TEST KITS. — SEPTEMBER/OCTOBER 2023

MALAYSIA: MDA ANNOUNCED TRANSITION PERIOD OF REGISTRATION APPLICATION WITH EXEMPTION FROM COMPLIANCE ASSESSMENT PROCESS BY COMPLIANCE ASSESSMENT BODY (CAB) FOR REGISTRATION OF COVID-19 TEST KITS. — SEPTEMBER/OCTOBER 2023

  • 2023-09-27 06:46:28

The Medical Device Authority (MDA) announced transitional period on July 14th for the registration of Covid-19 test kits, which the registration applications would be subjected to the compliance assessment procedure conducted by the compliance assessment body (CAB).

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MALAYSIA: MDA ANNOUNCED A NEW APPROACH TO EXPIRED EC CERTIFICATES FOR NEW REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICE — AUGUST/SEPTEMBER 2023

MALAYSIA: MDA ANNOUNCED A NEW APPROACH TO EXPIRED EC CERTIFICATES FOR NEW REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICE — AUGUST/SEPTEMBER 2023

  • 2023-08-23 06:00:06

The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.

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MALAYSIA: MDA announced the Third edition on Guidance on Medical Face Mask and Respirator – JULY/AUGUST 2023

MALAYSIA: MDA announced the Third edition on Guidance on Medical Face Mask and Respirator – JULY/AUGUST 2023

  • 2023-07-21 02:46:26

The Medical Device Authority (MDA) published the Third Edition Guidance Document, "On Guidance on Medical Face Mask and Respirator", on May 19, 2023. This document is intended to give clarity on medical face masks and respirators regulated by the Medical Device Act (Act 737). This document applies to establishments, healthcare facilities, and the general public who deal with medical face masks and respirators.

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