Malaysia: NPRA Updates Drug Labeling Requirements for Animal-Derived Ingredients
The National Pharmaceutical Regulatory Agency (NPRA) recently released an update of the Drug Registration Guidance Document (DGRD) to...
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ARQon
Sep 42 min read
Malaysia: MDA Introduces Updated Guidelines for Medical Device Registrations with Expired EC Certificates and Self-Declared Class B IVDs
Medical Device Authority (MDA) only recognized EC Certificate (CE Marking) issued under Directive 90/385/EEC, 93/42/EEC, or 98/79/EC, or,...
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ARQon
Jun 181 min read
Malaysia: MDA Revokes Compliance Assessment Process Exemption for COVID-19 Test Kit Registration
The Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter...
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ARQon
Jun 112 min read
Malaysia: MDA Implements One License Per Establishment Role Policy (w.e.f 1 July 2024)
Based on the General Directive of the Minister of Health No.1/2024 , announced on 15 April 2024, following the provisions of the Medical...
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ARQon
May 141 min read
Malaysia: Navigating Trade Barriers for Medical Devices in Nations without Diplomatic Ties
Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device...
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ARQon
Jan 27, 20212 min read
Special Access Routes for Covid-19 Related Products - ASEAN Countries
Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...
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ARQon
Jan 30, 20201 min read
Malaysia: Updates on Medical Device Act 2012 (Act 737)
This is the latest gazettement of the Medical Device Regulations pursuant to the Medical Device Act 2012 (Act 737). The gazettement took...
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ARQon
Jan 21, 20201 min read
Malaysia: Import/Supply of Unregistered Medical Devices for Demonstration for Marketing or Education
This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...
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ARQon
Jan 21, 20201 min read
Malaysia: Circular Letter of the Medical Device Authority No.2 Year 2018 (Revision 2)
Control Of Orphaned, Obsolete and Discontinued Medical Device In Hospital, Healthcare Facilities Institution Or Any Related Facilities...
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ARQon
Jan 21, 20201 min read
Malaysia:Training by the Authority: Compulsory Competency Module for Biomedical Technical Personnel
Date 12 February 2020 (Wednesday) | 8.00 AM – 5.30 PM (TRAINING) 13 February 2020 (Thursday) | 8.00 AM – 10.30 AM (EXAMINATION) Venue...
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ARQon
Dec 26, 20192 min read
Malaysia Halal Medical Device Standard MS 2636: 2019
In September 2019, Malaysia halal medical device standard is published, known as: MS 2636 : 2019 Halal Medical Device - General...
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ARQon
Dec 4, 20192 min read
Asia, Africa & Middle East - Nov/Dec 2019
Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...
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ARQon
Nov 1, 20192 min read
Malaysia Awareness on Non-Corrective Contact Lens as Medical Device
Non-corrective contact lens is regulated as medical devices by the Medical Device Authority (MDA). According to the Medical Device...
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ARQon
Nov 1, 20191 min read
Malaysia: Compulsory Competency for Biomedical Technical Personnel
MDA announced the training for competency module (regulatory requirements) for biomedical technical personnel. The module is designed to...
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ARQon
Aug 30, 20191 min read
Asia, Africa & Middle East - Aug 2019
Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...
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ARQon
Aug 28, 20193 min read
Malaysia: Medical Device Regulatory Updates
Circular Letter No. 1 Year 2019: Post-market Responsibility for Manufacturer and Authorized Representative Who Have Closed Their...
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ARQon
Jun 28, 20192 min read
Asia, Africa & Middle East - Jun 2019
Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...
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ARQon
Jun 28, 20193 min read
Post Market Step up enforcements by Singapore HSA and Malaysia MDA
SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...
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ARQon
Jun 28, 20192 min read
Malaysia MDA Announcement: Placement in the Market and the Use of Non-registered Device without Clin
On 24 Apr, Malaysia MDA made an announcement regarding the placement in the market and use of non-registered device without clinical...
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ARQon
Jun 28, 20191 min read
Asia Reg News: AHWP Catch-up, Korea, Malaysia, Indonesia and Vietnam Updates
Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...
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