Pre-marketing Control
General Control of Medical Devices (Category I devices)
Producers, importers or distributors who produce, import, or sell category I devices do not need to have a license, but they need to submit the certificate of free sale (CFS), which is issued by the health authority or relevant government body in the country of origin of the product imported into Thailand. Therefore, the CFS submission must comply with the Ministerial Notification No. 6 for importation.
Pre-marketing Notification (Category II devices)
Under Section 35 and 35(3), the Minister has the authority to declare, as notified in the Government Gazette, what kinds of medical devices require FDA approval with regard to their effectiveness, quality and safety.
Producers, importers or distributors of medical devices in category II (pre-marketing notification) are required to submit details on product descriptions, usage, specifications, labeling, and name of producers and distributors to the FDA. A certificate of free sale in the country of manufacture is also required for importing devices in this category.
Pre-marketing Approval (Category III devices)
Devices that fall under Section 35(1) are required to register with the FDA for approval before they can be manufactured, imported or sold. The operators must comply with the Ministerial Regulations Nos. 1, 2, 3, and 5 of B.E. 2533 (1990).
However, the devices specified under category III must have a licence for production, import, or sale. The licence for production or importation shall be deemed as a licence for production, importation or sale, but it must possess the qualifications imposed in Section 14. The licensee is also required to submit the information on production, import, sale, and adverse reactions of their devices to the FDA in accordance with rules and procedures described in the Ministerial Regulations.
Labeling of Medical Devices
Every medical device sold or possessed for sale must bear a label on its container or package with Thai texts. The following information must appear on the label:
- name, category, and type of the medical device;
- name and location of producer or importer; in case of importer, the name of producer and place of origin of such device must also be shown;
- quantity contained therein;
- number or letters indicating a lot number of production;
- licence number;
- purpose of use, instructions for usage and storage;
- a medical device for single use must display the words “disposable” or “for single use” in clearly visible red color;
- warnings and precautions;
- an expiry date, if any;
- other messages as notified by the Minister in the Government Gazette.
Control of Advertisement
The Act also prohibits advertisements with false or exaggerated statements regarding the purpose of use, quality, quantity, standard or place of origin of any devices.
Any means of advertisement, messages, audio, or videos for beneficial purposes must be approved by the FDA. The grantor has the authority to issue a written order to terminate any advertisement that is a breach of the Act (see Sections 41, 42 and 43).
