Singapore 2/3

Mar 29, 20191 min read

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)...

275 views0 comments

ARQon

Mar 28, 20191 min read

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...

299 views0 comments

ARQon

Mar 28, 20191 min read

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,...

135 views0 comments

Good News: Singapore Immediate Placement for Class B & C with 1 Reference Regulatory Approval

ARQon

Dec 17, 20182 min read

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....

93 views0 comments

Key Endorsements in the 7th AMDC Meeting

ARQon

Dec 11, 20181 min read

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...

111 views0 comments

ARQon

Dec 10, 20182 min read

Singapore HSA drafts user-friendly ASEAN CSDT Guidance and e-Submission Guide, complements ARQon tal

Singapore HSA has recently announced possible changes to the guidance documents GN-17 and GN-18. These changes are currently opened for...

74 views0 comments

ARQon

Nov 5, 20181 min read

Asia, Africa & Middle East - Dec 2018

AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...

17 views0 comments

ARQon

Aug 30, 20181 min read

Singapore incorporated IMDRF Essential Requirements including Cybersecurity

Singapore: HSA preparing manufacturer for the new ER IMDRF elements and cybersecurity. The new version Essential Requirements (ER)...

49 views0 comments

ARQon

Aug 30, 20181 min read

HSA & ARQon active role in Medtech product development for local and global requirements

Local Compliance HSA has recently set up an Innovation Office, a regulatory advisor for product development, in pursuit of greater...

57 views0 comments

ARQon

Aug 30, 20181 min read

ASEAN - 25th meeting of the Pharmaceutical Product Working Group (PPWG)

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...

596 views0 comments

ARQon

Aug 30, 20182 min read

Fees increase after years in Singapore HSA & Philippines FDA, and yearly approach increase by US

Singapore The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality,...

70 views0 comments

Tabulation of Singapore regulation changes in HSA guidance notes

ARQon

Jun 7, 20181 min read

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...

210 views0 comments

ARQon

May 14, 20182 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...

53 views0 comments

ARQon

Apr 11, 20187 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...

664 views0 comments

ARQon

Mar 21, 20183 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...

106 views0 comments

ARQon

Aug 24, 20171 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...

19 views0 comments

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...

760 views0 comments

ARQon

Jul 11, 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...

23 views0 comments

ARQon

May 31, 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...

64 views0 comments

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...

19 views0 comments

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