Gazette Volume 137, Section 2074, published in November of 2020 announced that medical devices sold to healthcare professionals are now exempt from some previous advertising requirements in Thailand. Under the new notification, medical device manufacturers do not need advertising approval anymore if they are selling products to healthcare professionals.
The previous regulations for advertising approval will still apply to manufacturers selling to hospitals. The Medical Device regulations in Thailand require that all advertising material (e.g., print, internet, or video) used in Thailand for a registered medical device must have advertising approval by being reviewed and licensed by the Thai FDA as per Notification B.E. 2553 (2010). Applications are processed in 30 days for a fee of ThB 1,000. Once issued, Advertising Licenses are valid for up to 3 years.
Per Volume 137, Section 260, advertising claims that do not include descriptions of the product’s indications, benefits, quality, standard, or any components of the origin of the device. Therefore, advertisements that only use the trade or brand name and generic messaging are exempt from seeking permission.
Using Asia Actual as your License Holder in Thailand comes with the added benefit of expertly managed, efficient and transparent advertising approvals.
Contact Asia Actual for more information on our advertising approval service.