Healthcare markets in Asia: overview of Thailand’s medical device market
Pacific Bridge Medical
In the first of a new series of articles addressing Asian healthcare markets, Ames Gross discusses Thailand’s medical device market.
In the past few years, Thailand has suffered horrible floods, a political coup and months of street protests. Nonetheless, the $1.5 billion medical device market actually grew at a rate of 9% each year. The medical device market will continue growing, as the demand for healthcare rises with the country’s economic development.
Public hospitals in Thailand account for roughly 55% of the total medical device purchases. However, private hospitals in Thailand are poised to be good places for Western companies as they seek to enhance their medical device equipment with more sophisticated products.
Today, roughly two-thirds of the medical devices in Thailand are imported. Thailand relies on these imports for higher value and more sophisticated medical devices. Generally, the local manufacturers tend to produce lower-end medical devices in Thailand, which are more labor intensive, such as disposable syringes, disposable test kits and surgical latex gloves.
In Thailand, medical devices with the best growth opportunities tend to be surgical procedure equipment, diagnosis equipment and devices to treat lung and heart diseases. Examples include respiratory devices, orthopedic implant devices, heart valves and neurosurgical devices. The dermatological device market also has good potential, as standalone skin care and dermatological clinics are becoming more popular.
Classifications of medical devices in Thailand
Medical devices in Thailand are regulated by the Medical Device Control Division under the Thai Food and Drug Administration (TFDA). The classification system in Thailand is reversed compared to many global markets. In Thailand, Class I devices receive the most regulation, and Class III devices have the least regulation. Class I devices are named “License” medical devices because they require full registration with the TFDA prior to sale or manufacturing. Currently, there are only seven devices categories as Class I – insulin disposable syringes, examination gloves, surgical gloves, HIV test kits and contact lenses.
“…the $1.5 billion medical device market actually grew at a rate of 9% each year.”
There are only 5 medical devices classified as Class II devices by the TFDA. They are breast enhancement products, physical therapy products, alcohol detectors, and HIV test kits for research and study. Class II medical devices are named “Notification”, because these medical device products do not need to be fully registered. Instead, the companies only need to notify the TFDA and fill in appropriate documents prior to importing or marketing these Class II devices.
Regardless of risk, all medical devices that are not indicated as Class I or II will automatically be classified as Class III products. Most medical devices actually fall under Class III in Thailand. These medical devices are named “General” medical devices because they do not require a complete product registration.
Thailand medical device registration
The registration requirements for medical devices in Thailand depend on their classification. For instance, to sell the “General” Class III devices in Thailand, the TFDA requires a general import license, a product specific import license and a local Thai entity.
Local entities can be independent third parties, a distributor or a subsidiary of the foreign device manufacturer. These entities must be registered with the Thai government. The general import license is a license issued by the Thai government which allows the local entity to import general medical devices into Thailand. Foreign device manufacturers, especially those without an office, do not always need to obtain this license, as most distributors and independent third parties in Thailand should already have this license.
“The registration requirements for medical devices in Thailand depend on their classification.”
The product specific import license is used to import specific products. To apply for this license, the TFDA requires several documents, such as the company’s commercial registration, its Certificate of Incorporation or Partnership which states the company’s objectives, a Certificate of Free Sale, etc. Class III medical devices which are implanted will also be required to obtain an ISO 13485 certificate or a good manufacturing practice (GMP) certificate. The Certificate of Free Sale should state the manufacturer’s name, the medical device’s name, model, type or product code, as well as indicate that the product can be sold in the country that it is manufactured.
The product specific import license can be approved in a few days if the above documents are submitted without errors. Nonetheless, oftentimes the TFDA will request supplementary or missing documents. Hence, companies should expect 3–5 months to receive the product specific import license from the TFDA.
After obtaining the product specific import license, the TFDA will inform the Customs department to allow the “General” Class III device to be cleared after being imported into Thailand.
Part 2 of this ‘Healthcare markets in Asia’ series, looking at the healthcare market in Singapore, will go live on 21st September.
About the author:
Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asia market. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit http://www.pacificbridgemedical.com/.
How do you think the medical device market in Thailand will develop?