Thai FDA Updates List of Chemical Pollutants
The TFDA has updated their list of chemical pollutants to comply with the Stockholm Convention on Persistent Organic Pollutants.
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Asia Actual is the Best Medical Device Consulting Company in Asia
Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
Thailand Fast Tracks Class D Medical Device Registration with Singapore Approval Status
The Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4 in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be exempted from the Specialist Review requirement in Thailand.
Thai FDA Updates Medical Device Applications Fees
On September 30, 2021 the Thai FDA published (reference Gazette Volume 138, Special Section 239N) a revised fee schedule covering medical and diagnostic device registration applications, license establishments, quality systems, and other review processes.
Thai Requirements for COVID Test Kits
Similar to other markets in the region, manufacturers of COVID test kits will need to undergo in-country validation as part of the Class 4 Licensing process in Thailand.
Thailand Implements New Medical Device Regulations
On February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.
New Advertising Exemption in Thailand
A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.
Thai FDA Ramps Up Documentation Requirements for General Medical Devices
With the announcement of The Regulations and Conditions Of Maintaining Technical Documents For Safety And Effectiveness Of The Medical Device, the Thai FDA has begun requiring the local medical device License Holder to provide upon request technical documents for any registered device. As the registration process for most General Medical Devices (all but 10 device types fit into this category) does not involve technical documents, this new requirement will impact most medical devices.
THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET
Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.
LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND
The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.