Thailand: Wound Dressings Under Medical Device Perspectives
The Thailand Food and Drug Administration (TFDA) has released an infographic outlining the classification of wound dressings as medical...
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ARQon
Aug 281 min read
Thailand: TFDA Releases Guidance on Diagnostic Test Registration for Monkeypox
On 20 August 2024, the Medical Device Control Division of TFDA released registration guidance for monkeypox (Mpox) diagnostic tests as a...
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ARQon
Jul 21 min read
Thailand: Thai FDA Streamlines Medical Devices Registration Pathway (w.e.f 6 June 2024)
Effective 6 June 2024, the Thailand Food and Drug Administration (TFDA) has executed the new announcement on the registration...
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ARQon
Jun 51 min read
Thailand: Thai FDA Simplifies Paperwork by Exempting 3 Document Requirements (w.e.f 1 May 2024)
Effectively from 1 May 2024, the Thai FDA decided to exempt 3 hard copy document submissions for all registrants who deal directly with...
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ARQon
Feb 5, 20211 min read
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...
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ARQon
Jan 27, 20212 min read
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...
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ARQon
Jan 3, 20201 min read
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...
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ARQon
Dec 24, 20191 min read
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...
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ARQon
Aug 28, 20191 min read
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...
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ARQon
Jun 18, 20191 min read
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...
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ARQon
Mar 28, 20191 min read
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...
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ARQon
Dec 17, 20182 min read
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...
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ARQon
Dec 11, 20181 min read
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...
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ARQon
Aug 30, 20181 min read
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,...
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ARQon
Aug 30, 20181 min read
MEDTECH ASSOCIATIONS REGULATORY NETWORKING - Malaysia, Philippines, Thailand & Vietnam
ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device...
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ARQon
Apr 11, 20187 min read
The 6th ASEAN Medical Device Committee (AMDC) Meeting 3-6 April 2018
Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...
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