- Feb 5, 2021
Thailand: Advertisement of medical devices that do not require permission
Thai FDA had come up with a set of advertising specification for medical devices that are exempted from obtaining a medical device...
- Jan 27, 2021
Special Access Routes for Covid-19 Related Products - ASEAN Countries
Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...
- Jan 3, 2020
Thailand Breast Implant Regulation: B.E. 2562
Breast Implant regulation: B.E. 2562 Main content revision from regulation B.E. 2540 Signed date: 7 November 2019 Announced date: 18...
- Dec 24, 2019
Thai FDA ‘Concise Evaluation’ alternative replacing Free Sale Certificate or Country of Origin Cert
Thai FDA issued an announcement for alternative Concise Evaluation route for registering Notified and Licensed medical device, including...
- Aug 28, 2019
Thai FDA: Medical Device Act (2nd edition)
The Thai Food and Drug Administration released the amended Medical Device Act (2nd edition) 2019 which will replace its predecessor, the...
- Jun 18, 2019
Thai FDA publishes New MD Act
New Medical Device Act Recently, Thailand FDA has just announced new Medical Device Act (more information will be given in an update...
- Mar 28, 2019
7th AMDC: ASEAN Borderline and Harmonized Classification documents released
The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...
- Dec 17, 2018
Thailand FDA shares 2019 Medical Device Regulation Plan
During the 7th AMDC Meeting, the medical device control division released updates on the pre-market and post-market control of medical...
- Dec 11, 2018
Key Endorsements in the 7th AMDC Meeting
The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...
- Aug 30, 2018
ASEAN - 25th meeting of the Pharmaceutical Product Working Group (PPWG)
ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...