Thailand Food and Drug Administration (FDA), the country’s regulating authority in the sphere of medical devices, has published several guidelines dedicated to certain important aspects related to the marketing of medical devices in Thailand. In particular, the new documents are addressing the issues related to direct advertising of medical devices to healthcare professionals, and also the labeling requirements the devices should meet.
Direct Advertising Requirements
One of the documents issued by the Thailand FDA provides medical device manufacturers, importers, suppliers, distributors, and other parties involved in operations with medical devices with additional information and clarifications regarding the country’s requirements on direct advertising to healthcare professionals. The document describes the applicable regulations, methods, and conditions, and also outlines certain exemptions when special advertising permission is not required.
First of all, it is important to mention that the advertising of medical devices is regulated under the Medical Devices Act and special regulations issued by the Ministry of Public Health.
According to the document, direct advertising means the conveying of messages for the benefit of trade and includes sales promotion as well, while direct advertising to medical and public health practitioners stands for advertising medical devices by the virtue of any advertising medium or method only to medical and healthcare professionals.
The scope of the present guidance covers both medical devices subject to state registration and ones exempted from mandatory registration.
According to the document, direct advertising to healthcare professionals should be performed only in the following forms:
- Video materials,
- Telephone advertising,
- Digital advertising.
In case of advertising conducted without special permission (in accordance with the exemption rule), the appropriate message should be explicitly communicated to the audience in the form of text or sound depending on the type of advertising.
The interested party intended to commence direct advertising of medical devices to healthcare professionals without special permission should also duly notify the regulating authority about such activity. The guidance published by the Thailand FDA contains a template of such notification to be submitted by the advertiser. According to the template, a notification about direct advertising to healthcare professionals should contain the following elements:
- Information about the advertiser, including its name, address, and contact details.
- Name of the medical device in question,
- The regulatory status of medical devices (e.g. licensed/registered or exempted from registration, or in the process of research),
- Type of advertising materials to be used (e.g. publication in a journal, book, leaflet; or video, etc.),
- Information about place and timing of advertising media distribution,
- Methods to be used to limit direct access to advertising materials to healthcare professionals,
- The evidence of advertising directly to healthcare professionals,
- A statement signed by the authorized person certifying that all information provided hereabove is correct and complete, and the advertiser would comply with the applicable rules and requirements set forth by the Medical Devices Act.
Labeling for Medical Devices
Another guidance document issued by the Thailand FDA describes the requirements for the labeling and regulatory documents for medical devices, and also the appropriate rules and procedures.
According to the general rules set forth by the Medical Devices Act, any and all medical devices marketed in Thailand should be accompanied by the appropriate labeling and documentation necessary to ensure the safe use of such devices.
First of all, the document provides the definitions of the most important terms, namely:
- Home used medical devices – the ones intended to be used by laypersons in locations falling outside the scope of the medical environment (e.g. at home), including the devices intended to be used by healthcare professionals outside healthcare facilities, as well as the devices intended to be used both inside and outside the healthcare facility,
- Medical devices for healthcare professionals (professional use medical devices) – the ones that are not intend to be used by laypersons; i.e. the devices intended to be used only by healthcare professionals or under their supervision.
The entity responsible for medical devices placed on the market (e.g. manufacturer, importer, or distributor) shall ensure that any and all statements included in the labeling are correct. The authority additionally emphasizes that the labeling of the device, as well as any additional documentation accompanying it, should not contain any misleading claims regarding the functions and features of the device. Moreover, the labeling of the device should be subject to approval and meet the following requirements:
- The labeling for medical devices intended for general use should be provided in Thai, while it can also contain other languages,
- The labeling for professional use medical devices could be provided in Thai or English, and can also contain additional languages as well, providing that the information provided in other languages does not contract to the one provided in Thai or English,
- The labeling should be placed in a clearly visible area, where it could be easily read,
- The labeling should contain at least the following details: the name of the device, description of its essential components and principles of work, intended purpose, amount of devices in packaging, the method of use (unless it is could be reasonably deemed as obvious), the name and location of the manufacturing facility and of the importer and country of origin (if applicable – for foreign medical devices), the number of licenses under which the device is placed on the market, the name, address and telephone number of the contact person the information requests or complaints could be addressed to, the indication of production date and time, including the serial number (in case if a device has an expiration date, it should be also indicated), and also the safety warnings, contraindications or cautions necessary for safe use of the device. The regulating authority also states that certain elements listed hereabove could be provided in additional documentation instead.
- The information addressed solely to healthcare professionals could be provided in English or using English abbreviations. In some cases, the abbreviations could be used instead of text, provided that they are explained when needed in supplementary documentation.
In case of documentation related to medical devices intended to be used by the general public, the last revision date should be indicated as well.
It is also important to mention that the Thailand FDA allows providing additional information in the electronic format using QR code and website easily accessible by laypersons and healthcare professionals.
The document also contains a list of excluded medical devices – the ones for which the labeling is not required – namely:
- Surgical instruments and devices designed to be reused,
- Medical devices for which the labeling and documentation are not required under the special prescription of the Ministry of Public health.
Summarizing the information provided here above, the new guidance documents issued by the Thailand FDA provide additional clarifications regarding certain specific requirements related to direct advertising of medical devices to healthcare professionals, and also the labeling requirements for both professional uses medical devices and ones intended to be used by the general public. The second guidance outlines the information to be included in the labeling of medical device and supplementary documentation supplied with the device, and also describes the particular way such information should be provided. The document also describes certain cases when the labeling and supplementary documentation is not required.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.