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Tabulation of Singapore regulation changes in HSA guidance notes
HSA has revised its guidance documents and the changes will be taking place from 1 June 2018 onwards. ARQon has collated a list of the...
ARQon
Jun 7, 20181 min read
Class A Medical Device Register
During the HSA Industry Briefing held on 28 February 2018, all Class A Medical Devices (sterile and non-sterile) will have exception from...
ARQon
May 14, 20182 min read
The 6th ASEAN Medical Device Committee (AMDC) Meeting 3-6 April 2018
Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...
ARQon
Apr 11, 20187 min read
Summary of Singapore Medical Device Regulation changes (HSA briefing on 28 February 2018)
At the latest HSA briefing held on 28 Feb 2018, it was announced that a revised regulation is targeted to be rolled out in June or July...
ARQon
Mar 21, 20183 min read
MEDTECH ASSOCIATIONS REGULATORY NETWORKING, July 2017 - Singapore, the Philippines, Myanmar
THE FIRST MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...
ARQon
Aug 24, 20171 min read
Class A Singapore Medical Device Register (SMDR)
HSA has announced the implementation of the Class A Medical Device Register for public access on 10 August 2017.This register allows...
ARQon
Aug 24, 20171 min read
Singapore To Make Major Medtech Regulatory Changes Under Economic Growth Plan
Executive Summary: Regulatory and Market Access Improvements for medtech products were on the agenda at last month's Health Products...
ARQon
Jul 11, 20171 min read
SINGAPORE Health Products Regulatory Forum (held 18-19 May 2017)
To drive the Singapore Committee on the Future Economy (CFE), HSA will be putting in place the following: Singapore Pre-market...
ARQon
May 31, 20171 min read
Singapore Consults On Implementing New Device Distribution Standard
Executive Summary: Singapore’s Health Sciences Authority is inviting feedback on a draft guideline to help medical device importers and...
ARQon
May 31, 20171 min read
Progress seen for Regulatory Guidelines of Telehealth Devices in Singapore
The proposed regulatory guidelines for telehealth devices by the Health Sciences Authority (HSA) for public consultation has been closed...
ARQon
Dec 13, 20162 min read
More Green Channel Fast Track by China Food and Drug Administration (CFDA)
In late October 2016, ARQon meeting with CFDA on the exchange sharing of fast track authorization route in Singapore and the Green...
ARQon
Dec 6, 20162 min read
Therapeutic products: New Regulations & Clinical Trial of medical device: CRM replacing former t
The Health Sciences Authority of Singapore (HSA) introduced the Health Products Act (HPA) in 2007 in which their aim is to consolidate...
ARQon
Oct 14, 20162 min read
Removal of Singapore Quality Overall Summary from Drug Product Registration in Singapore
The Singapore Quality Overall Summary (SQOS) was introduced in 2007 to provide information specific to product registration in Singapore....
ARQon
Oct 14, 20161 min read
Updates by HSA on Guidance documents with clarification on grouping
Health Sciences Authority of Singapore(HSA) recently updated the Guidance documents with clarification on grouping (GN-12-1-R2 and...
ARQon
Jul 31, 20161 min read
New Singapore Standard will be replacing the current Technical Guidance by the end of the year
Health Science Authority (HSA) will be rolling out a new Singapore Standard(SS) as early as November 2016. This new guidance will be...
ARQon
Jul 31, 20161 min read
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