Thai FDA, with the new Medical Devices Act 2019, slightly changed rules and regulations in Advertising Medical Devices in Thailand
Let’s see in detail what changes; for any further question you may email us.
“Advertisement” means an act by any means which causes the public to see, hear or acknowledge content for commercial purposes and shall include a sales promotion campaign;
“content” includes the display of letter, shape, artificial mark, picture, motion picture, light, sound, mark or any act which causes the public to understand a meaning;
“sales promotion campaign” means the offer of information, persuasion or an act by any means which induces a sale;
“advertisement medium” means an object used as a medium for advertisement, such as:
(1) printed matters (e.g. pamphlet, flier, book, newspaper, magazine, journal, medical journal, billboard, poster, decal, etc.);
(2) radio transmitter, loudspeaker, television;
(3) radio broadcast, projector or film, cable television, fax, video recording;
(4) digital medium (e.g. internet, mobile phone, etc.);
(5) advertisement on an object or vehicle;
(6) other materials and media.
A person who wishes to advertise a medical device must receive a medical device advertising licence from the licensor and must comply with other conditions prescribed by the licensor. A medical device advertising licence shall be valid for a period not exceeding three years from the date of issue of licence. An application for a medical device advertising licence (Form KhorPhor. 1) and the medical device advertising licence (Form KhorPhor. 2) shall in accordance with the documents appended to this Notification.
Warnings in Advertising Medical Devices in Thailand
Advertising Medical Devices in Thailand is prohibited in case of advertisement of benefits, quality, quantity, standard, composition or origin of medical device which is false or exaggerated, in whole or in part, or has the characteristics of deceiving or concealment of facts, regardless of whether or not there is a use or reference to an academic report, statistic or any other exaggerated or false material, such as:
Terms that can’t be used in Advertising Medical Devices in Thailand
The activity of Advertising Medical Devices in Thailand must not fall into following cases:
1) boastful or deceptive advertisement, e.g. use of words such as “top”, “supreme”, “special”, “magnificent”, “excellent”, “best”, “absolute”, “complete cure”, “worry-free”, “immediate”, “instant”, “holy”, “miracle”, “safe”, “safest”, “most suitable”, “number one”, “first”, “most”, “certain”, “better”, “overcome serious diseases”, “peace of mind”, “confident”, “rare opportunity”, “non-allergic”, “no side effects”, or the use of other words, terms, pictures or sounds having a similar meaning;
2) advertisement showing more details than specified in the label or manufacturer’s medical device documentation, unless supported by evidence or a reliable academic publication, but such advertisement must not relate to details on the indication or purpose of medical device use.
Advertisement which shows endorsement or praise of medical device benefits by a person, whether directly or indirectly.
3) Advertisement which offers a chance to receive a prize by any means.
4) Advertisement which shows benefits on the ability to prevent, cure, relieve, treat a disease or symptoms of a disease which is banned by Notification of the Minister.
5) Advertisement showing a content which is deceptive in regard to the essence of the medical device.
Other cases at risk of penalties from Thai FDA
6) Advertisement of a medical device name which is boastful, false, deceptive, misleading or contrary to good morals and Thai tradition.
7) Advertisement which is impolite to the public or directly or indirectly supports an illegal act or an act contrary to good morals and Thai tradition, or leads to a deterioration of national culture, or could cause detriment to society as a whole.
8) Advertisement which could cause disharmony or disunity among the people.
9) Advertisement which induces a consumer to receive services or overuse a medical device repeatedly more than necessary or unsuitably, such that there could be harm from the use or understanding that regular use is suitable.
10) Advertisement conducted by a method which could be harmful to health, body or mind or could cause annoyance for consumers.
11) Advertisement which discredits or compares to a medical device of another operator, except for comparisons to one’s own products or academic comparisons, and in any event the name of medical device or product technology of other persons must not be mentioned.
This, and much more has been changed in regulation of Advertising Medical Devices in Thailand. If you want to register your products and market them, it’s highly recommended you use a professional service provider as your consuntalt and License holder. Contact us for a quote: https://www.siamdevelopment.com/en/contacts/
Source, and for more information: http://www.fda.moph.go.th/Pages/HomeP_D2.aspx