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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August 29, 2019

Myanmar FDA shared the following statistics:

Local Manufacturer

  • Manufacturers for low and medium risk device: 6, excluding small and medium enterprises and export-only device factories

Myanmar announced the updates on: 

1. Exemption List of Medical Devices


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 17, 2018

Myanmar releases updates on the various changes to their regulatory process in the most recent 7th AMDC Meeting.

The Myanmar Department of Food and Drug Administration gave news on their harmonization to ASEAN Medical Device Directive:

  • The Myanmar regulatory process...

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.


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 


  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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