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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 TRANSITION PERIOD FOR THE IMPLEMENTATION OF ELECTRONIC MEDICAL DEVICE REGISTRATION CERTIFICATE –  JULY/AUGUST 2023

MALAYSIA: MDA ANNOUNCED THE TRANSITION PERIOD FOR THE IMPLEMENTATION OF ELECTRONIC MEDICAL DEVICE REGISTRATION CERTIFICATE – JULY/AUGUST 2023

  • 2023-07-21 02:38:16

The MDA announced a transition period for the implementation of electronic medical device registration certificates on May 22nd, 2023. This announcement is intended to provide information on the use of Electronic Medical Device Registration certificates, which will be fully implemented on January 1st, 2024, and no more physical medical device registration certificates will be issued by MDA.

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QT ANALYSIS: The Impact of Unique Device Identification (UDI) System on Medical Device Registration – June/July 2023

QT ANALYSIS: The Impact of Unique Device Identification (UDI) System on Medical Device Registration – June/July 2023

  • 2023-06-28 09:59:48

Qualtech's big topic for this month's edition provides an overview of the Unique Device Identification (UDI) system implemented by territories serviced by Qualtech for medical devices. The UDI system aims to improve patient safety, traceability, and identification of medical devices on the market. The implementation of the UDI system offers benefits such as faster traceability, standardized post-market safety activities, and improved buying and waste disposal policies.

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MALAYSIA: MDA Announced the Fifth Edition on the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products – March/April 2023

MALAYSIA: MDA Announced the Fifth Edition on the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products – March/April 2023

  • 2023-03-27 09:16:15

The Medical Device Authority (MDA) published the Fifth Edition Guidance Document, "Guideline for Registration of Drug-Medical Device and Medical Devie-Drug Combination Products", on January 03, 2023. This document is intended to provide information on how to apply for an endorsement letter, post-approval changes/variation applications for ancillary components, adverse drug reactions and incident reporting for the registered combination product.

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MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

  • 2023-02-23 01:35:01

The Medical Device Authority (MDA) published the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10) on January 11, 2023. The MDA created this guidance document to assist the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.

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