The growing population, prolonged lifespan of citizens and the demand for better healthcare has contributed significantly to the Medical Device Market in Thailand. In 2030, it is predicted that 25% of the population in Thailand will be over 60 years and thus give rise to the need of more elaborate healthcare services. It is also important to note that the number of foreign patients receiving treatment has reached 2.35 million people in 2014 and this number is expected to increase annually. Therefore, Thailand is now projecting itself as a Hub for Healthcare in ASEAN. With the government’s economic reform plan, Medical Devices will be prioritized as a target industry by offering a special incentive package.
Medical Device Control Division (MDCD) is a regulatory authority underneath Thai Food and Drug Administration (TFDA) established in June 1990, to control manufacturing, importing, selling and advertising of medical devices in Thailand. The classes of Medical Devices are categorized into 3 groups; Licenses Medical Devices (Class I), Notified Medical Devices (Class II), General Medical Devices (Class III).
Table 1: Classes of Medical Devices in Thailand
| Class I | Class II | Class III |
|---|---|---|
| Licensed Medical Devices | Notified Medical Devices | General Medical Devices |
| Insulin Disposable syringes Condoms Surgical Gloves Blood Bags for human HIV test kits for diagnostic Contact lens |
Physical Therapy devices Alcohol Detector devices Silicone Breast Implants Methamphetamine Test Kits Ophthalmic Viscosurgical device(OVD) Breast Enhancer Concentrate for haemodialysis |
Other medical devices which are not licensed or Notified medical device |
In Thailand, Class I devices are the most strictly regulated, which requires full data set for registration with the TFDA before selling or manufacturing. In contrast……
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