Thailand: Draft for the Announcement of Requirements for Selling of Medical Devices

The Ministry of Public Health (MOPH) issued a draft announcement pertaining to the criterions, procedures, and conditions for selling of medical devices in the Thai market.

The following are the key points from the draft announcement:

1. Certain medical devices must only be sold to consumers who have obtained a prescription from a healthcare professional. The said medical devices can be found in the appendix of the translated draft announcement that can be accessed here;
2. In cases where a hospital with medical professionals, or a licensed medical device seller purchases medical devices listed in the appendix, they may do so without a prescription from a medical professional;
3. Sellers of medical devices shall obtain a license from the Government;
4. Sellers of medical devices shall keep all records pertaining to the sales of medical devices, including the name of the consumer, date of selling, and details of the sold medical devices. These records must be kept for at least 5 (five) years.
5. Sellers of medical devices who were operating before the announcement came into force must obtain a license within 188 days of the announcement’s effective date. They may continue to operate until the licensing authority issues an order of disapproval.

This draft announcement will come into force after 180 days from the date of publication in the Royal Gazette.

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.