Thailand Medical Tourism and Healthcare Sector Growth

With the title of ‘Worlds Most Visited Medical Tourism Destination’ Thailand has seen a significant increase in interest from foreign investors in the healthcare sector. Significant investments are being made in the private and public healthcare sector, medical equipments, drugs and medical devices sectors. The annual growth late last year of the medical device and medical equipment market alone was 15%. Also, the ageing population and rising mortality crisis in Thailand is resulted in an increased investment in this sector.

The major causes of death in Thailand are:

• Heart Diseases
• Hypertension
• Respiratory tract disorders
• Metabolic diseases

Thailand Hospitals and Clinics Infrastructure

Being a major medical tourism destination, the private healthcare sector hospitals in Thailand (Thailand Hospitals) are rapidly increasing to attract foreign patients with their high quality, low cost services. However, a major deterrent to the growth of the private hospitals is that they must serve patients covered under the low cost universal healthcare system which was introduced by the government in 2000. Below are the schemes under which the population of Thailand is covered:

• 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: Individual and private firms.
• Universal Coverage Scheme (UCS): Thai citizens not covered under CSMBS or SSS

There are over 723 community hospitals, 321 private healthcare hospitals, 71 general healthcare hospitals and 26 regional healthcare hospitals. They are segmented as:

1. Elite
2. Upper Mid-Tier
3. Mid-Tier
4. Non-Profit Hospitals

As per Ministry of Health Thailand (2011), there were 18,000 clinics in Thailand with 22% of them situated in Bangkok.

Thailand Medical Device Imports and Market Trends

87% of medical devices and equipment used by hospitals are imported into Thailand. X-rays and scanner equipment alone contributed over US $80 million in 2006. Other medical equipment commonly imported into Thailand are nebulizers, infusion systems, fetal monitors, ECG equipment, and autoclaves. The medical device market including orthopedic implants, dental implants, crowns, wound healing products, bandages, catheters, syringes, needles, stents etc. are primarily imported into Thailand.

Thailand is trying to encourage local manufacturing particularly in products which require the use of rubber for medical products such as rubber gloves, and other disposable products. The government is also promoting local production of in-vitro diagnostics, syringes and needles. The Thailand Science Park has been established to promote research and development in the medical devices and equipment sector, with over fifty private companies currently incubated there.

There are over 500 medical device importers in Thailand, with most located in the greater Bangkok region. The top 3 import sources into Thailand are the USA, Japan and Germany.

The medical device market has grown at an average rate of 16% over the last three years, with 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%)

Thai FDA and Medical Device Regulations

The medical device and supplies sector is strictly controlled by the Thai Food and Drug Administration (Thai FDA) and Ministry of Public Health. They classify medical devices into three sectors:

• General Control / Class III: Producers, importers or distributors of products which do not require a Thai local license. These products require a label in Thai text.
• Pre-Marketing Notification / Class II: Items such as HIV test kits, rehabilitation devices, silicone implants, and blood alcohol measuring kits. Information must be submitted to the FDA, along with a certificate of free sale in the country of manufacture.

Licensed Devices / Class I: Importers of these devices must register with the FDA and obtain a license for production, import or sale. Products in this category include syringes, contact lenses, surgical gloves and IVDs.

Performance and Safety Evaluation in Device Registration

In addition to classification, the Thai FDA also evaluates requests for expert review of performance and safety documentation. This applies particularly to:

• New technology devices, such as AI-driven innovations.
• Devices intended for home use, such as lasers and LEDs.
• Products requiring efficacy and safety checks, such as hyaluronic acid-free products, silk-based products, and PRPs.
• Devices with a history of severe adverse events or flaws that could harm patients or the environment.
• Equipment with specific Ministry of Public Health notifications.

Exemptions from Expert Review

Certain devices are exempt from requiring external expert review if they meet specific criteria, including:

• Previously registered medicinal products.
• Devices historically supplied to government agencies or hospitals, with proven safe use for at least three years.
• Devices with identical specifications, formulations, packaging, and manufacturing details to those already licensed.
• Products approved by the Medical Device Control Division.

In such cases, internal reviewers may assess the product, and only escalate to external experts if necessary. Authorization can also be obtained by referencing original documents of previously approved devices, provided no changes in formulation, indication, or packaging occur (other than changes in importer or manufacturer details).

Medical Device Act B.E. 2551 (2008) and Advertising Regulations

Thailand’s Medical Device Act B.E. 2551 (2008), amended in 2019, governs the registration, import, manufacture, sale, and advertising of medical devices. These updates were introduced to align Thai regulations more closely with international standards.

The Ministry of Public Health has issued specific guidelines for advertising medical devices. In general, medical device advertisements promoted through any media that do not describe detailed characteristics, advantages, quality, standards, components, or point of origin may be exempt from requiring advertising authorization.

Key provisions include:

• Clause 1: Devices promoted without specific claims that could influence consumer decision-making may be exempt.
• Clause 2: Certain medical devices explicitly excluded from clearance requests under Ministry notifications.
• Clause 3: All advertising must comply with Chapter 7 guidelines of the Act.
• Clause 4: This declaration is effective from the date of publication in the Government Gazette.

These provisions aim to protect consumers while allowing companies limited freedom to promote devices responsibly without overstating product features or benefits.

Conclusion

With South East Asia showing rapid economic growth, countries such as Thailand, Philippines, Indonesia, India, Malaysia, and Singapore have seen an increase in consumer spending, lifestyle improvement, and demand for advanced medical treatments. Healthcare manufacturers can capitalize on this growth to succeed in the region.

It is important to take into consideration the local regulatory requirements, either directly or via medical device regulatory consultants. Patient-focused investments in this sector can reap a healthy return, and companies like Morulaa HealthTech can provide essential support in navigating the complex medical device registration and advertising compliance processes across Thailand and other Southeast Asian nations.