The ARQon Gazette News

      Global Regulatory & Quality Bulletin 
The ARQon Gazette is a compilation of latest updates in the medical device and drug industry. These updates might have an impact to manufacturers and other industry participants.
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January 2, 2020

Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in Singapore.


The Health Sciences Authority (HSA)'s Medical Devices Branch (MDB) has released a draft document for consultation by 31 Jan...

December 26, 2019

WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (WHO SAGE IVD)

The World Health Organization (WHO) has established a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body to matters of global policies and strat...

December 26, 2019

In September 2019, Malaysia halal medical device standard is published, known as:

MS 2636 : 2019 Halal Medical Device - General Requirements.

This MS 2636 standard is a voluntary basis and a value added guidelines to the industry to serve the users requiring halal affirm...

December 26, 2019

The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN countries to harmonise requirements of cosmetic products so as to reduce technical barriers to trade in the region. The ACD was implemented in Singapore from 1 January 2008. 

The ASEAN Cosmetic Committee (AC...

December 26, 2019

ARQon shared industry view in ASEAN meeting 5 years back on having recognition like Hague Apostille Convention, finally came true.

Philippines is the first ASEAN countries for removal of authentication of foreign public documents. Some countries product registration lik...

December 25, 2019

MDR 'Up-Classified' Class I Medical device Extension

European Parliament finalized the EU MDR Second Corrigendum following ENVI and INTA committees announcement on Monday 16 December 2019 and published the Second Corrigendum on 17 December 2019. Click here for...

December 24, 2019

Thai FDA issued an announcement for alternative Concise Evaluation route for registering Notified and Licensed medical device, including IVD devices. This alternative route allows Manufacturer to use the reference agency approval document instead of the Country of Orig...

December 24, 2019

MOH Indonesia published the Guideline for Consultation with MOH Directorate Medical device and House-hold product on 24 December 2019, for consultation via email and using the ANTRIAN online system.

MOH Indonesia also announced on 30 October 2019 on the Fee changes to r...

December 23, 2019

The Vietnamese MOH has released the proposed amendment in end 2019 to the Vietnamese medical device industry while waiting for the documents to be officialized.

These will further amend the Decree No. 169/2018/ND-CP ("Decree No. 169") and Decree No. 36/2016/ND-CP relati...

December 20, 2019

HSA final document presents the specific requirements applicable for NGS IVDs that are to be submitted for registration. The scope of this document covers both NGS based IVD tests intended to aid in diagnosis of individuals with suspected germline or somatic mutation-r...

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