Thailand’s medical device market was worth more than $850 million in 2012 and is set to expand at 7.5 percent annually over the next several years. Almost all categories of imported products posted double digit growth rates in 2011, with diagnostic imaging growing by 18.7 percent. The medical device market in Thailand continues to boast strong economic growth, even in the face of a global slowdown.
Thailand has continued to support its universal healthcare system by raising the per capita healthcare expenditure. From April 2009 through 2011, this went up from $75 to $82. According to the World Health Organization, Thailand’s total expenditure on healthcare was about 4.4 percent of GDP in 2011. And as the country continues to develop, demand for better healthcare is likely to increase as well.
The Medical Device Control Division of Thailand’s Food and Drug Administration (FDA) is responsible for protecting consumer health by ensuring the quality, safety and efficacy of medical devices in Thailand. All devices are regulated under the Medical Device Acts B.E. 2531 and 2551, passed in 1988 and 2008, respectively.
MEDICAL DEVICE CLASSIFICATIONS
Foreign medical device companies wishing to sell their products in Thailand must first register them according to a risk-based classification system. This system is the exact opposite of that used by the US FDA, which considers Class I devices to be the lowest risk. In Thailand, Class I devices — called “licensed” devices — have the highest risk classification. They are more stringently controlled than Class II and Class III devices, which are referred to as “notification” and “general” devices. Classification requirements are as follows:
- Class I “licensed” devices — These are the only products that require full registration and a Product License from the Thai FDA. Only seven medical devices are included in this category:
- Examination gloves
- Surgical gloves
- Sterile hypodermic disposable syringes
- Sterile insulin disposable syringes
- HIV test kits for diagnostic use
- Contact lenses
- Class II “notification” devices — These items require notification to the Thai FDA before they can be imported and put on the market. They include:
- Physical therapy products
- Alcohol detectors
- Implanted silicone breast prostheses
- Breast enhancements
- HIV test kits for research and study
- Class III “general” devices — These are any medical devices that do not fall into the “licensed” and “notification” categories, and cover nearly 90 percent of all applications. Once a general medical device has been validated, it must have an Import License before it can be imported to or sold in Thailand.
IMPORT LICENSE REQUIREMENTS
If all required paperwork is properly completed and submitted in a timely manner, it takes the Thai FDA between 3 – 5 months to issue an Import License for a Class III “general” device. If required documents are not fully completed or submitted, it takes the Thai FDA additional time to request and receive information. Once the FDA issues an Import License, the Thai Customs Office is notified to permit clearance of the Class III medical device when it arrives in Thailand.
Documents required to import a Class III “general” medical device into Thailand include:
- A Certificate of Free Sale and the Good Manufacturing Practice (GMP) Certificate from the country of manufacture
- Two copies of the company’s Commercial Registration
- A copy of the company’s establishment documents
The Certificate of Free Sale must include the name of the manufacturer, assembler or packager and location; the name of the medial device with a list of classification information including model, type, size and product code; and documentation showing that the medical device is sold in the country of manufacture.
The GMP certificate must include the name of the manufacturer, assembler or packager and location; the classification and type of medical device manufactured; and the period of validity for the GMP certificate. If the period of validity is not specified, the GMP certificate should not be more than two years old.
MEDICAL DEVICE LABELING
All medical devices sold or marketed in Thailand must be labeled in Thai and include the name, category, and type of medical device, the name and location of the manufacturer or importer, the intended use, instructions for usage and storage, warnings and precautions, and the License number, if it is a Class I medical device.