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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August 28, 2019

Medical Device control system

  • In Laos there are 72 Import drug-medical device companies, who are representative for local distribution. There are 34 companies run business for medical devices, 1 Medical Device Factory

  • Almost 100% of medical device products are...

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

Current situation in Laos:

  • 36 Companies involved in medical device market

  • 1 medical device factory

  • 98% of medical devices are imported

  • Public Private Partnership covers medical devices placed in healthcare facilities such as the central hospital or ce...

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...

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