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There is new guidance that is effective immediately from the Medical Device Authority (MDA) in Malaysia. It released Appendix 1,5th Revision of Circular Letter of the Medical Device Authority 2 Year 2014 (Appendix 1-Revision 4). This appendix describes the process for conducting conformity assessment by way of verification of the evidence for medical devices that […]

Malaysia’s Medical Device Authority (MDA) has released draft guidance on 12 April 2022, for labelling registered medical devices. The draft guidelines are open for stakeholder comments until 28 April 2022. This fifth edition introduces the following additions or changes: Location of Labelling General contents of labelling Instructions for use (IFU) Use of specific statements This

On 6 April 2022, Malaysia’s Medical Device Authority (MDA) released draft guidance for change notification on registered medical devices. The draft guidelines are open for stakeholder comments until 20 April 2022.  This document provides guidance to determine the correct categories of changes to continue importing, exporting, or placing registered medical devices on the market. This

Malaysia’s Medical Device Authority (MDA) issued a reminder on 5 April 2022 that imported medical devices must be registered and imported by a licensed establishment as provided in sections 5 (1) and 15 (1), Medical Devices Act 2012 (Act 737) or obtain any approval issued by MDA. If you are involved in importing medical devices,

The Medical Device Authority (MDA) said that based on the definition under section 2 of Act 737, only disinfectants used to disinfect  medical devices are categorized as medical devices. Other disinfectant products including body spray disinfectant are not categorized as medical devices and therefore they are not subject to the control of Act 737 enforced

The Medical Device Authority (MDA) decided on 29 March 2022  to replace the requirement of lot-to-lot variation tests. Instead, it’s instituting the approval of a new lot of COVID-19 test kits with the requirement under the post market duties and obligations of the establishment. With this arrangement, the establishment shall inform MDA of any new

The MDA Covid-19 assessment Committee Of experts has agreed that all Covid-19 test kit applications pending Conditional Approval and Special Access will be halted. In addition, all future applications will be submitted using the Medcast online system. The deadline for applications pending in CA and SA is set for March 3rd, 2022. All establishments must

First edition guidance on the classification of rehabilitation, physiotherapy, and speech therapy devices was issued by the Ministry of Health Malaysia on 22 April 2022. The Medical Device Authority (MDA) published the guidance document to outline the terms and definitions of rehabilitation, physiotherapy, and speech therapy. This provides manufacturers and authorized representatives a guide to

The purchase of self-test kits for COVID-19 requires providing personal information at sales premises authorized by MDA and KPDNHEP, and the collection of this information is a growing concern among buyers. MDA is aware of the concerns among users and would like to clarify that the requirement to record this personal information is imposed on

Malaysia’s Ministry of Health’s Medical Device Authority (MDA) released a draft amendment or second edition of Medical Device Guidance (MDG) for Personal Protective Equipment (PPE) requirements. The amendment is to the September 2021 first addition MDA/GD/00558. The draft document provides guidance to healthcare facilities and establishments. Specifically, those that deal with requirements for PPE that

The Malaysian Medical Device Authority (MDA) has released guidance on the requirements for registering Refurbished Medical Devices (MD/GD/0060). The guidance document provides information on how to register a refurbished medical device before it can be placed in the Malaysian market. What is a refurbished medical device? According to the ASEAN Medical Device Directive (AMDD), it

Malaysia’s Medical Device Authority (MDA) has released draft guidance for the classification of rehabilitation, physiotherapy and speech therapy devices. Industry stakeholders are invited to comment on the draft guidelines until 2 March 2022. The guidance states that the classification as a medical device will be made upon the clear indication of the mode of action

Malaysia’s Medical Device Authority (MDA) has released draft guidance on medical device grouping classification rules. The draft guidelines are open for comment by stakeholders until 28 February 2022. The purpose of the document is to provide guidance on determining the appropriate grouping for medical devices during the medical device registration application. This draft guidance applies

The Malaysian Medical Device Authority (MDA) has launched an enhanced version of MeDC@St, its online application system for medical device registrations, at the end of January 2022. MeDC@St 2.0+ will incorporate additional features such as changes to certain modules including: Change Notification module Change notification applications are now allowed to combine Category 2 and Category