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.
July 1, 2025
Approximately 5 minutes
The Role of the Medical Device Control Division (MDCD) within the Thailand Food and Drug Administration (TFDA)
The Thailand Food and Drug Administration (TFDA)
The Thailand Food and Drug Administration (TFDA) is the national regulatory body and competent authority responsible for overseeing the registration, evaluation, and monitoring of various products, including food, drugs, and medical devices, to protect public health and consumer rights.
🏥 The Medical Device Control Division (MDCD)
Medical device registration and regulation within the TFDA is specifically managed by the Medical Device Control Division (MDCD), established in 1991. The key responsibilities of the MDCD include:
- Pre-Market Evaluation: Evaluating the safety, quality, and efficacy of new medical devices before they can be sold in Thailand.
- Enforcement: Enforcing compliance with medical device regulations and taking action against non-compliant entities.
- Post-Market Monitoring: Conducting surveillance and monitoring devices after they are on the market to ensure continued safety and effectiveness.
📜 Regulatory Framework Modernization
Thailand's medical device regulatory process is primarily based on the Medical Device Act B.E. 2551 (2008), which was subsequently updated by the Medical Device Act/Ordinance B.E. 2562 (2019).
In an effort to modernize its framework and align with regional standards, the Thai government ratified the ASEAN Medical Device Directive (AMDD) in 2015. This alignment has led to several significant regulatory updates in recent years, including:
- Updates to classification and technical documentation requirements.
- Implementation of specialist review requirements for certain medical devices.
- Mandatory annual report submission from all license holders.
- Introduction of a fast-track route for specific, low-risk devices.
💻 e-Submission and Online Tools
The MDCD has implemented measures to streamline the application process for new devices, largely relying on its e-Submission Interface. This electronic portal is central to the pre-market registration process for manufacturers and their local License Holders.
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 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
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.