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, 2020
- 1 min
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, 2020
- 1 min
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, 2020
- 1 min
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, 2020
- 1 min
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, 2019
- 2 min
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, 2019
- 2 min
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, 2019
- 2 min
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, 2019
- 1 min
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, 2019
- 1 min
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, 2019
- 3 min
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, 2019
- 2 min
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, 2019
- 3 min
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, 2019
- 2 min
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, 2019
- 1 min
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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ARQon
- Mar 29, 2019
- 1 min
Asia, Africa & Middle East - Mar 2019
Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...
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ARQon
- Mar 28, 2019
- 1 min
7th AMDC: ASEAN Borderline and Harmonized Classification documents released
The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...
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ARQon
- Mar 28, 2019
- 1 min
ASEAN Updates for Malaysia, Vietnam: Asian Medtech Associations Regulatory Networking
Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...
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ARQon
- Dec 17, 2018
- 1 min
Malaysia MDA Announces Medcert 2.0 and Email & Website Changes
With effective as of 2 January 2019, Medical Devices Authority will make the following changes: Malaysia MDA also recently introduced 2...
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ARQon
- Dec 17, 2018
- 1 min
Malaysia Unregistered Route for Export-Only & Diagnostics-Only Devices
MDA shed the light on the following statistics: Total establishment license: 2,300 Establishments; Manufacturers: 230 Authorized...
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