REGULATORY NEWS & UPDATES

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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December 4, 2019

  • Australia: Proposed changes to the Essential Principles for safety and performance

  • Australia: Proposed changes to the requirements for systems and procedure packs

  • Australia: Feedback sought on the regulation of certain self-testing IVDs in Australia

  • ...

August 28, 2019

Indonesia Encourages Investment

  • Economic growth shows an increasing trend, and this includes the Pharma and Medical Device Industry

  • New strategic infrastructure such as highway, airport, dam, powerplant,  railway, etc.

  • Economic deregulation to simplify a...

June 28, 2019

Executive Summary:

Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market developments and Asian Harmonization Working Party news. Part 2 was a guest presentation on the current Brexit and EU IVDR outlook. This...

May 30, 2019


PP JPH has been signed by the President on 29 April 2019 and promulgated on 3 May 2019. However, the PP copy has not yet been published, waiting for a government press release.

The contents of the PP are more general regarding cross-ministerial and institutional cooper...

March 29, 2019

Online Medical Device Classification Guideline

MOH Indonesia provides online classification guideline to help applicant to define the risk classification of the medical device, the device category and its subcategory, product type and HS code. 

Digital Signature

MOH Indon...

March 28, 2019

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of Standards & Technical Requirements by ASEAN Medical Device Committee (AMDC):​

December 14, 2018

Indonesia is attempting to simplify regulations by reducing the time needed for review, promoting easier access for license application and to develop the local manufacturing sector. 

New Registration Timeline

Indonesia is launching Digital signature system in January 20...

December 11, 2018

The AMDTC is working on the following two key work items:

  • Classification of products as Medical Device or Non-Medical Device in the different ASEAN Member States (AMS);

  • Risk classification of identified medical devices with a view to align among the AMS.

The...

August 30, 2018

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam and representatives from the ASEAN Secretariat. The Representatives from ASEAN Pharmaceutical Industry Club...

April 11, 2018

Questions for ASEAN 

General

  1. Can we have the slides from the regulators update?

  2. What changes can to AMDD can be expected with EU MDR and EU IVD update and when?

  3. What are the change notification procedures for the different countries (particularly for Vietna...

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