Medical Device Registration in Thailand 2018-05-31T10:24:32+00:00

Market Opportunity in Thailand

The Kingdom of Thailand is the second largest economy of Southeast Asia and is one of the leading medical hubs in the world.

The increasing demand for medical services in Thailand is attributed mainly to the country’s universal healthcare system. The system has three programs including the Civil Servant Medical Benefit Scheme, the Social Security Scheme and the Universal Coverage Scheme. Together, these cover almost all the citizens in both urban and rural areas.

In addition, the growing population and prolonged lifespan of citizens has contributed significantly to the country’s healthcare market. The ageing population can be considered one of the major catalysts for the demand of medical devices and medicine. It is estimated that by 2030 approximately 25% of the population in Thailand will be over the age of 60.

Moreover, the increasing number of hospitals with high-quality treatment options has supported the growth of the country’s healthcare market. Medical devices such as surgical procedure apparatus, orthopedic implant devices and rehabilitation equipment are devices that are in high demand in the country.

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While local medical device manufacturing is growing steadily, Thailand also welcomes foreign manufacturers looking to import their devices into the country, in particular, some of the more sophisticated devices that may not be available locally. Approximately 2/3 of the medical devices in Thailand are imported. Thailand’s healthcare market is approximately $16 billion and 4.17% of its GDP. Thus, Thailand offers a great market opportunity for both local and foreign medical device investors.

Andaman Medical can act as your in-country representative

The Medical Device Control Division under the Thai Food and Drug Administration (FDA) is the regulatory body that oversees medical device regulation in Thailand. In order to market a device in Thailand, the device must fulfil its requirements according to its risk classification. The Thai FDA categorizes medical devices into the three categories:

i. Class I: Licensed Medical Device

ii. Class II: Notification Medical Device

iii. Class III: General Medical Device

Class I devices are the most stringently controlled devices of the three classes. In general, a basic requirement for all classes of medical device is a Certificate of Free Sale, Certificate of a Quality Management System such as ISO 13485 and instructions for use. Foreign manufacturers who do not have a legal entity based in Thailand will need to appoint a local representative to import the device. Andaman Medical is able to act as your representative in Thailand and can manage the registration process on your behalf to support you in successfully importing the device into the country.

Services

For foreign manufacturers who are not established in Thailand, Andaman Medical is able to represent you in the country. Andaman Medical can be your local representative to assist you in the product registration process and to support post-market activities such as adverse event reporting and customer complaint management.
Depending on the classification of your medical devices, Andaman Medical will assist you in compiling the dossier for submission to the Thai FDA to obtain marketing authorization for your device. Basic requirements for all classes of medical device include a Certificate of Free Sale, a Certificate of a Quality Management System such as ISO 13485 and instruction for use.
Andaman Medical offers general consulting services such as the provision of regulatory intelligence reports, medical device classification, registration and Thai labelling requirements.