The Secretary-General of the Food and Drug Administration hereby issues the draft announcement as follows:
Section 1: This Announcement shall be effective from the day following its publication in the Government Gazette.
Section 2: Guidelines for submitting applications for medical device advertising that requires academic document evaluation are as follows:
- Display of advertising messages that may fall under the category of false or misleading claims about the benefits, quality, quantity, standards, components, or origin of a medical device that may lead to misunderstandings about the essential characteristics of the medical device;
- Academic comparison of own medical device product with others;
- In the case of medical devices with an approved license, notification license, or listing license has a serious adverse event (SAE) or device deficiency that may lead to a serious adverse device effect (SADE).
This announcement shall take effect from the day following its publication in the Government Gazette. Further information can be accessed here กองควบคุมเครื่องมือแพทย์ (moph.go.th) (in Thai)
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