Thailand Medical Device Regulation and Healthcare Market Growth

Thailand Medical Tourism, Healthcare Sector Growth, and Thailand Medical Device Regulation

"World’s Most Visited Medical Tourism Destination" Thailand is a country that has received much attention from the foreign investors due to its rising healthcare sector. Investments are coming from the private and public sector, medical equipment, pharmaceutical and medical devices industry. Medical device and medical equipment market annual growth rate was estimated at 15% last year.

Moreover, the change in the Thailand medical device regulation frameworks (newly enforced 2025/2026 labeling and advertising frameworks), aging population and health crisis situation in Thailand are the other factors that encourage investment in the healthcare sector.

The leading causes of death in Thailand are:

• Heart diseases

• Hypertension

• Respiratory tract disorders

• Metabolic diseases

Thailand Hospitals and Clinics Infrastructure

As one of the main medical tourism destinations, the hospitals in the private sector of the healthcare of Thailand are developing rapidly. But, an obstacle for the development of these hospitals is that these hospitals are also responsible for servicing patients insured in the low cost universal healthcare system, introduced by the government back in 2000. There are several schemes of coverage in which the population of Thailand is included:

• Civil Servant Medical Benefit Scheme (CSMBS): Government employees and their dependents.

• Compulsory Social Security Scheme (SSS): Private employees or temporary public employees.

• Private health insurance: Individuals and private firms.

• Universal Coverage Scheme (UCS): Thai citizens who are not covered in CSMBS or SSS.

There are 723 community hospitals, 321 private healthcare hospitals, 71 general healthcare hospitals and 26 regional healthcare hospitals, classified as Elite, Upper Mid Tier, Mid Tier, and Non Profit Hospitals. According to the Ministry of Public Health Thailand, there are over 18,000 clinics in Thailand of which 22% are in Bangkok.

Medical Device Importation in Thailand

About 80% to 87% of medical devices and equipment utilized in the hospitals are imported in Thailand. Previously X-rays and scanner equipment have made a contribution of over US$ 80 million. Other equipment that is usually imported in Thailand include nebulizers, infusion systems, fetal monitors, ECG equipment, and autoclaves. The medical device market including orthopaedic implants, dental implants, crowns, wound healing products, bandages, catheters, syringes, needles, and stents is usually imported in Thailand. 

Thailand is trying to encourage local manufacturing, especially those that make use of rubber in the manufacture of medical products such as rubber gloves and other disposable products. Thailand is encouraging local production of in vitro diagnostics, syringes, and needles. There is the Thailand Science Park that has been set up for promotion of research and development in the medical devices and equipment market. Over fifty private companies are being incubated in the Thailand Science Park. 

There are more than 500 medical device importers in Thailand, with the majority of them found in the Greater Bangkok area. Top 3 sources of imports into Thailand are the United States, Japan, and Germany. It is important to understand the regulation pathway in the medical devices and equipment in order to stay ahead of the competition.

Growth in the medical devices and equipment sector has been recorded over the last three years at 16%, with the following segment specific growth rates as follows:

• General Supplies (24%)

• Ophthalmology (24%)

• Diagnostic and Therapeutic equipment for Internal Medicine (18%)

• Dental (14%)

• Surgery (-35%)

• Laboratory (16%)

• Orthopedic, orthosis and disability aids (13%)

• Medical Logistic and patient ward (38%)

• Diagnostic imaging and radiotherapy (28%)

• General Equipment (35%)

Thailand Medical Device Regulation and Food and Drug Administration

The medical device and supplies sector is regulated by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration, which is part of the Ministry of Public Health. To align with regional and international framework like the ASEAN Medical Device Directive (AMDD), medical devices are categorized in a four class risk based classification system (which replaces the previous three sectors of classification system):

• Class 1 (Low Risk - Listing): This class involves low risk tools and animal medical devices. Since January 2025, the qualifying Class 1 devices are subject to automatic approval upon submission through the e Submission system, thus no waiting time. License is valid for 5 years.

• Class 2 (Low Moderate Risk - Notification): This class involves a little bit more detailed evaluation and a Certificate of Notified Medical Devices. The application is required to be submitted in ASEAN Common Submission Dossier Template (CSDT) format. It is valid for 5 years.

• Class 3 (Moderate High Risk - Notification): Same with Class 2 but with CSDT format evaluation and a Certificate of Notified Medical Devices. Valid for 5 years.

• Class 4 (High Risk / Life-Sustaining - Licensing): This involves licensing approval and thorough technical and clinical dossiers evaluation. Valid for 5 years.

Moreover, an Abridged Pathway was created in June 2024 for devices that have had at least one year of approval from recognized global regulatory bodies (US FDA, EU Notified Bodies, or Australia TGA) in order to reduce the approval process. Also in June 2025, the Thai FDA has introduced license transfer through the CSDT fulfillment mechanism, to facilitate smoother transfer of the license between importers without having to re-register again from scratch. Lastly, the annual compliance report submission deadline was changed to May 31st of each year (effective from March 2026).

Performance and Safety Evaluation in Thailand FDA Medical Device Registration

Apart from general risk categorization, the Thai Food and Drug Administration reviews requests for assessment of performance and safety data by an expert. It is particularly important when dealing with medical device registration in Thailand in the case of:

• Novelties, including technological inventions (e.g., AI powered ones).

• Devices meant for household use, like lasers and LEDs.

• Product lines needing to be assessed for efficacy and safety, like those without hyaluronic acid, those made of silk, and PRPs.

• Medical devices associated with serious adverse effects or defects posing danger to patients or the environment.

• Equipment with special Ministry of Public Health notifications.

Exemptions from Expert Review

However, there are certain devices which are not required to have an external expert review based on the following criteria set by the Thailand Food and Drug Administration.

• Registered drugs before.

• Those devices which have been provided to any governmental organizations or hospitals and their use is found to be safe for more than three years.

• Those devices whose specifications, formulations, packaging, and manufacturing details are same as that of licensed one.

• Devices approved by the Medical Device Control Division.

In such a situation, internal reviewers of the Thai Food and Drug Administration may evaluate the device and seek external expertise when needed. In addition, authorization may be sought even without external review with respect to original documents of the device that was already approved, provided there is no change in formulation, indication, and packaging (except that of the name of the manufacturer and importer). Failure in providing correct Thailand medical device classification criteria in the dossier may delay the internal reviewer process.

Medical Device Act B.E. 2551 (2008) and Modern Labeling Frameworks

The Medical Device Act B.E. 2551 (2008) has undergone several updates, including Act B.E. 2562 (2019), which brought Thai legislation in line with international standards and AMDD risk classification. One of the latest amendments to Thai Medical Device Legislation has been made through the Medical Device Labeling Regulation (B.E. 2568) that came into effect on June 20, 2026. This regulation includes all previously announced notifications and establishes rules for IFU and labeling:

• Determination of Home Use and Professional Use: In order to ensure consumer safety, home use device labels and IFUs shall be made exclusively in the Thai language. On the other hand, professional-use devices may use both languages.

• Digital IFU: For the first time, this regulation recognizes the possibility of using QR codes and digital IFUs for software medical devices and connected systems when the information remains available even offline.

• Special Devices Labeling: For reusable surgical and dental instruments, the labeling must include the number of validated sterilization cycles, storage conditions and period after opening. Standalone software should contain the version information and UDI if it is available.

• Reduced Time for Import Labeling Completion: Time to complete the labeling process after import at customs has been reduced from 180 to 120 days.

Updated Medical Device Advertising Rules (B.E. 2568 / 2025)

The Ministry of Public Health and Thai FDA implemented the latest Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025), which will come into effect on January 4, 2025, officially revoking the previous B.E. 2564 (2021) regulations. The regulations to be strictly adhered to are:

• Advertising Licensing Requirement: Anyone wishing to advertise the medical device must obtain an explicit license for advertising (Form Kor Por. 2 from Form Kor Por. 1 application). The validity of the advertising license is up to three years and requires Form Kor Por. 3 for any amendments.

• Media and Formats: The new regime allows for expanded approval of not only static media but also dynamic digital media, electronic media, and QR codes.

• Mandatory Disclosures: All advertisements have to disclose the name of the medical device, contact information of the advertiser, license number of the advertisement, and notice the following statement: “Notice the warnings on the label and accompanying documents before use.”

• Prohibited Information: The absolute prohibition of any false, exaggerated, or misleading statements or unauthorized features/benefits. Prohibition of using the terms like "best," "perfect," "number one," "healing completely," "miracle" etc.

Finishing Thailand FDA medical device registration and obtaining advertising licenses are a must before marketing the device.

Conclusion: Strategies for Thailand FDA Medical Device Registration

Southeast Asia is picking up steam, and healthcare is one of the important aspects of this growth. In Thailand, Philippines, Indonesia, India, Malaysia, and Singapore, expenditures have risen. Consumers need more choices in terms of healthcare and this market is growing even further. In order to correctly introduce a product on the market, one needs to register it according to the Thailand FDA medical device registration process.

Understanding the requirements in terms of regulation and formal classification of devices into four classes takes time. However, there are a lot of business opportunities in it and one can get a nice profit on it. Navigating the new Thailand medical device regulation and advertising processes across the Thailand Food and Drug Administration is not hard.