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.
April 1, 2025
Approximately 5 minutes
Thailand Medical Device Local Labeling Requirements: Language, Content, and Post-Import Affixing
Thailand Medical Device Local Labeling Requirements
Medical device labeling in Thailand is governed by the Ministry of Public Health's Notification 137, specifically Section 260 D, which outlines the rules, procedures, and conditions for labels and package inserts. Proper local labeling is a mandatory component of market compliance.
🇹🇭 Language Requirements
The required language for medical device labeling depends on the device's intended user:
- Home-Use Devices: Devices intended for use by the general public (home use) must be labeled in Thai.
- Professional-Use Devices: Devices used directly by physicians may have their labeling in either Thai or English.
📝 General Labeling Content
All medical device labels and/or package inserts must include comprehensive information to ensure safe and proper use. Mandatory details include:
- Product Identification: Name of the product, License number, Serial number or Batch number.
- Manufacturer/Importer Details: Name and address of the manufacturer (and country), and the name and address of the importer.
- Usage Information: Indication, Quantity, How to use instructions, Storage conditions.
- Safety Information: Warnings, contraindications, and precautions.
- Dates: Manufacturing date and expiry date (indicating the year in a four-digit format, e.g., 2025).
📦 Labeling Flexibilities and Exemptions
The Thai FDA allows for certain flexibilities in applying the required information:
- Package Inserts: If required information cannot fit on the label, a separate package insert can be added. This insert can be in paper or electronic form (such as a QR code linking to a website or a CD).
- Post-Import Affixing: The local importer is permitted to affix the necessary labeling within 180 days of the medical device entering the country.
- Exemptions: Certain devices, such as those used for reusable surgery, may have limited labeling requirements, though they still must include essential data like the product name, manufacturer/importer details, batch/serial number, and manufacturing/expiry dates.
Related Articles
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 Advertising Approval: Rules for DTC and HCP Communication
The Thai FDA regulates medical device advertising based on the target audience. Direct-to-Consumer (DTC) ads require prior approval, while advertisements targeted solely at Healthcare Professionals (HCPs) are generally exempt, provided they are not visible to the public. Approval licenses are valid for up to 3 years.
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
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.