Medical Device Classification in Thailand is risk-based, as per ASEAN Directive received in 2018 and fully applied from 2021. According to its function, use, time and risk, a medical device may be classified in 4 categories, numbered from 1 to 4, with a related risk class (16 different rules). According to the result of such… [read more]

A license Holder, or Authorized Marketing Holder, is a Company authorized to Import products subject to authorization/license/registration on behalf of foreign companies. Mainly used for Healthcare products like Dietary Supplements, Cosmetics and Medical Device, License holding allow the manufacturer to keep the control of Intellectual property and of the market strategy for his product. A… [read more]

To Register a Dietary Supplement in Thai FDA the applicant shall provide the ingredient list for its products the source of the ingredients (with specific standards) the manufacturing process (including factory certifications) the objectives of use; and the targeted consumer group. Following data and information are required for food supplement registration in Thai FDA: Details… [read more]