Singapore: HSA stops provisional authorization applications for COVID-19 test & introduce PSAR
HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection, to...
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ARQon
- Feb 3, 2021
- 3 min
Singapore: Guidances for Covid-19 Test, Mask, Thermometer, Sanitizers, Ventilators & 3DP Devices
COVID-19 Diagnostic Test kits To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional...
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ARQon
- Jan 27, 2021
- 1 min
Singapore: Warning letters issued for fraudulent Covid-19 related claims
With increased surveillance on local e-commerce platforms and retail shops, over 1700 product listings have been removed for making false...
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ARQon
- Jan 27, 2021
- 2 min
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
Singapore HSA finalized Registration Requirements for Next Generation Sequencing (NGS) IVDs
Health Sciences Authority (HSA) has finalized the specific requirements for registration of Next Generation Sequencing based In-vitro...
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ARQon
- Jan 30, 2020
- 1 min
Singapore NEA: Listing Of Chemicals Under The Stockholm Convention
With effect from 12 Feb 2020, two new chemicals adopted for listing under Annex A of the Stockholm Convention (SC) will be controlled as...
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ARQon
- Jan 8, 2020
- 3 min
Notification by the National Environment Agency (NEA) of New Regulated E-waste Management System
1) The Resource Sustainability Act (RSA), introduced by the Ministry of the Environment and Water Resources (MEWR), is an integral part...
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ARQon
- Jan 7, 2020
- 1 min
Singapore Launch of OSCAR System for FSCA Reporting
Singapore Launch of OSCAR System for FSCA Reporting As part of HSA’s on-going effort to improve efficiency in our processes, HSA is...
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ARQon
- Jan 2, 2020
- 5 min
Software Regulation and FSCA update for Singapore, Clinical Requirements update for China, Personali
Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...
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ARQon
- Jan 2, 2020
- 3 min
Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft
Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...
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ARQon
- Dec 20, 2019
- 1 min
Singapore published Final Guidelines on Next Generation Sequencing NGS IVDs
Singapore Health Sciences Authority (HSA) final document presents the specific requirements applicable for NGS IVDs that are to be...
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ARQon
- Dec 20, 2019
- 1 min
Singapore NEA Additional Control List of Mercury-Added Product
Following the consultation with industry since Aug 2016, the Singapore National Environment Agency (“NEA”) gazette additional controls...
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ARQon
- Aug 29, 2019
- 1 min
Singapore: Medical Device Regulatory Updates
Medical Device Pre-market Registration A submission guide that maps the various modules in our MEDICS system to the ASEAN CSDT dossier...
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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
- May 30, 2019
- 1 min
IMDRF Clinical Documents for Public Consultation
The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...
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ARQon
- Mar 29, 2019
- 1 min
HSA launches Singapore OSCAR online FSCA reporting and GN-21 update
Singapore Health Sciences Authority (HSA) shared the following updates on 28 March 2019: Update to the GN21 Change Notification (CN)...
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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
- 2 min
Good News: Singapore Immediate Placement for Class B & C with 1 Reference Regulatory Approval
In recent ASEAN meeting, Singapore HSA has reiterated the country's initiative to enhance the facilitation of immediate market access....
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ARQon
- Dec 11, 2018
- 1 min
Key Endorsements in the 7th AMDC Meeting
The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...
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