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 28, 2019

The Thai Food and Drug Administration released the amended Medical Device Act (2nd edition) 2019 which will replace its predecessor, the Medical Device Act of 2008. The amended Medical Device Act (2nd edition) 2019 will come into effect in October 2019 and below is the...

June 18, 2019

New Medical Device Act

Recently, Thailand FDA has just announced new Medical Device Act (more information will be given in an update meeting on 19 June).

Medical Device Act (rev. 2) – main changes are:

  • new definition of “Medical Device” to exclude “spare part” not to...

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

During the 7th AMDC Meeting, the medical device control division released updates on the pre-market and post-market control of medical devices.

Pre-Market Control

An overview of the pre-market control of medical devices in Thailand is as seen in the diagram below:

 1. Ris...

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...

August 30, 2018

ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device regulation, which must be in place before the national elections; Vietnam's efforts to introduce practical, workable device regulatio...

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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