Thailand’s New Notification Regarding Rules, Methods and Condition for Display of Labels and Package Inserts of Medical Devices 2020

On 22 September 2020, Notification of the Thai Ministry of Public Health Re: Rules, Methods and Condition for Display of Labels and Package Inserts of Medical Devices B.E. 2563 [2020] was issued.

For the benefit of consumer protection,  medical devices must be properly labeled for safety purposes and to obtain the necessary information about the use and storage of medical devices. The licensed manufacturer or licensed importer of medical devices shall provide a label for the medical device. Package insert must not be false or with exaggerated claims or misleading. Labeling for the medical devices must be approved.

Medical devices used by the general public must have a legible label in the Thai language; Medical devices for healthcare professionals must have a legible label in Thai or English. The labels may contain other languages however those texts in other languages must have the same meanings and must be consistent and not in conflict with the Thai or English texts.

The document also specifies the minimum information required on the labels and the package insert and exemptions for certain medical devices.

This Notification shall come into force 365 days after publication in Government Gazette.
Please refer to the link below for further information:-
ประกาศกระทรวงสาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไขการแสดงฉลากและเอกสารกำกับเครื่องมือแพทย์ พ.ศ. 2563
https://www.fda.moph.go.th/sites/kbs/Shared%20Documents/เกี่ยวกับส่วน

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