THAILAND: Latest Regulation on Medical Device Labeling – …
Aug 26, 2021 · Thai FDA alerted Medical Device Establishment concerning labeling and device document implementation applicable for all 4 classifications; Licensed Medical Device (Class …
Thai FDA Streamlines Medical Device Approval Process with New ...
Sep 17, 2024 · The Thai FDA introduces new regulations effective June 6, 2024, reducing documentation requirements to streamline the medical device approval process, enhancing …
Thai FDA Refer and Transfer Processes for Medical Devices: Key …
Nov 4, 2024 · Discover the Thai FDA's new processes for Refer and Transfer, effective September 20, 2024. Learn how these methods simplify brand name changes and license …
FDA THAI : Food and Drug Administration, Thailand
Any person who wishes to manufacture or import medical devices shall carry out registration of an establishment with the Thai FDA. Step 2 : Product Registration. In order to regulate medical …
Thailand: Guide to Evaluating Medical Device Licensing Inspections
Jun 4, 2024 · Thai Food and Drug Administration (FDA) announced the Criteria, Methods, and Conditions for Evaluating Academic Documents, Analysis, Establishments Inspection or …
Thailand FDA Makes Changes to Acceptable Documentation for …
Aug 28, 2024 · The Thai FDA announced (June 5) that the technical documentation required for Class 2, 3 and 4 medical device registration has been reduced to lessen the regulatory burden …
Thailand: Thai FDA issues regulations on quality systems for …
From July 2024, new manufacturers of moderate-risk to high-risk medical devices must comply with the standards specified in the GMP Notification (which includes the obligation to obtain …
FDA THAI : Food and Drug Administration, Thailand
FDA Enhances Regional Health Product Approval Process for Faster, Transparent, and Fairer Service
THAILAND: New Guidance Document on Labelling of Medical …
Nov 5, 2020 · Ministry of Public Health has introduced a new guidance document regarding labelling of medical devices to be registered and sold in Thailand. This is to ensure consumers …
Thailand Medical Device Labeling - Asia Actual
Medical device labeling requirements in Thailand are addressed by the Ministry of Public Health’s Notification 137, Section 260 D, “ Rules, Procedures and Conditions for Labels and Package …