Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
June 1, 2025
Approximately 5 minutes
Thailand Medical Device Advertising Approval: Rules for DTC and HCP Communication
Thailand Medical Device Advertising Approval Requirements
The Thai Food and Drug Administration (TFDA) regulates medical device advertising based primarily on the target audience: Direct-to-Consumer (DTC) advertisements require prior approval, while those strictly targeted at Healthcare Professionals (HCPs) are subject to different rules.
📣 Advertising Direct to Consumer (DTC)
All advertising material directed toward the general public must be reviewed and approved by the TFDA prior to being displayed.
- Materials: This includes all final versions of advertising, such as print ads, web materials (ads, landing pages, blogs), and video content.
- Process: Applications are submitted by the License Holder via the e-submission portal.
- Timeline and Fees: The standard review typically takes about 30 days but can be extended if the TFDA issues inquiries. A government review fee (approx. US $100) is required.
- Validity: Once approved, the advertising license is valid for up to 3 years.
👩⚕️ Advertising to Healthcare Professionals (HCP)
Advertisements sold directly to hospitals or strictly targeting Healthcare Professionals (HCPs) are generally exempted from the prior advertising approval requirement.
- Exemption Condition: Manufacturers must submit the advertising material to the Thai FDA system via e-submission before using it. No full registration or approval is required.
- Public Access Restriction: If a professional-use medical device advertisement is visible to the public (e.g., on an ungated website), a full advertising registration is required. To maintain the exemption, access must be restricted, often requiring HCPs to sign in or provide their medical license number.
Devices Requiring Restricted Sale
Certain medical devices, due to their nature, must only be sold to hospitals or medical/healthcare professionals. Advertisements for these products must strictly restrict public access. Examples include:
- Ophthalmic Viscosurgical Devices (OVD)
- Silicone breast implants
- Injective Hyaluronic for defective skin
- HIV test kits (excluding self-test kits)
🚫 Exempt Marketing Material
Marketing materials that do not make specific claims about the product's indications, benefits, quality, standards, or origin are generally exempt from seeking permission. This includes advertisements that use only the trade or brand name and generic messaging.
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Approximately 5 minutes
Thailand Medical Device Registration and Approval: Compliance with Thai FDA and AMDD
Thailand's regulatory process, overseen by the Thai FDA's MDCD, follows the Medical Device Act B.E. 2562 (2019) and aligns closely with the ASEAN Medical Device Directive (AMDD). Devices are classified into four risk categories (1-4) and require one of three approval routes: Listing, Notification, or License.
Approximately 5 minutes
Thailand Medical Device Classification: Risk Categories and Thai FDA Verification
Medical devices in Thailand are classified into four risk categories (Class 1-4) based on intended use, invasiveness, and risk, closely following ASEAN MDD rules. Manufacturers can formally confirm their device classification by submitting an online application to the Thai FDA.
Approximately 5 minutes
Thailand Medical Device Grouping Rules: Simplifying Registration and Saving Costs
Thailand's new grouping guidance simplifies the registration process, allowing multiple products to be included in a single submission. Devices must share a product owner, intended purpose, and proprietary name, and can be grouped as a Single device, Family, System, Set, IVD Test Kit, or IVD Cluster, subject to specific variant rules.
Approximately 5 minutes
Thailand Medical Device Post-Market Surveillance (PMS) and Adverse Event Reporting
The Thai FDA requires device defects and Adverse Events (AEs) occurring globally to be reported if the product is on the Thai market, following AMDD Annex 5 guidelines. The local Registration Holder is responsible for submitting reports and maintaining distribution/complaint records for at least five years.
Approximately 5 minutes
Thailand Medical Device Local Labeling Requirements: Language, Content, and Post-Import Affixing
Thailand's labeling rules, detailed in Ministry of Public Health Notification 137, require all home-use devices to be labeled in Thai. Devices used only by physicians can use Thai or English. The importer can affix the required labeling, including essential product and manufacturer details, within 180 days of the device entering the country.
Approximately 5 minutes
The Role of the Medical Device Control Division (MDCD) within the Thailand Food and Drug Administration (TFDA)
The TFDA is the national regulatory body in Thailand, with the Medical Device Control Division (MDCD) responsible for enforcing the Medical Device Act B.E. 2562 (2019). The MDCD oversees pre-market evaluation, registration, and post-market monitoring, ensuring medical devices comply with safety and quality standards aligned with the ASEAN MDD.