Medical Device Registration In Thailand
Thailand is the second largest economy of Southeast Asia and is one of the leading medical hubs in the world. The Kingdom of Thailand is formerly known as Siam, is a unitary state at the center of the Southeast Asian Indochinese composed of 76 provinces. The capital and largest city is Bangkok, a special administrative area. Thailand is bordered to the north by Myanmar and Laos, to the east by Laos and Cambodia, to the south by the Gulf of Thailand and Malaysia, and to the west by the Andaman Sea and the southern extremity of Myanmar. The expanding interest in medical services in Thailand is attributed for the most part to the nation’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 covers almost all the citizens in both urban and rural areas for Medical Device Thailand.
Moreover, the growing population and prolonged lifespan of citizens have contributed essentially to the nation’s healthcare market. The ageing population can be viewed as one of the real catalysts for the demand of medical devices and medicine. It is evaluated that by 2030 roughly 25% of the population in Thailand will be beyond 60 years old.
Health and medical care are directed by the Ministry of Public Health (MOPH), alongside a few other non-ministerial government organizations, with total national expenditures on health adding up to 4.3 percent of GDP in 2009.
All medical devices are regulated by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA).
In addition, the expanding number of hospitals with high-quality treatment alternatives has supported the growth of the nation’s healthcare market. Medicinal devices, for example, a surgical procedure apparatus, orthopedic implant devices, and rehabilitation equipment are devices that are in high demand in the country.
While nearby medical device manufacturing is developing consistently, Thailand likewise invites foreign manufacturers looking to import their devices into the nation, specifically, a portion of the more complex devices that may not be accessible locally. Approximately 2/3 of the medicinal devices in Thailand are imported. Thailand’s healthcare market is around $16 billion and 4.17% of its GDP. Along these lines, Thailand offers an extraordinary market it’s an opportunity for local and foreign medical device investors.
The Medical Device Control Division under the Thai Food and Drug Administration (FDA) is the regulatory body that directs medical device regulation in Thailand. So as to showcase a device in Thailand, the device must satisfy its necessities as indicated by its risk classification. The Thai FDA arranges medical devices into the three categories:
- Class I: Licensed Medical Device
- Class II: Notification Medical Device
- Class III: General Medical Device
Thai FDA Medical Device Classification
Class I devices are the most stringently controlled devices of the three classes. In general, an essential requirement for all classes of medicinal device is a Certificate of Free Sale, Certificate of a Quality Management System, for example, ISO 13485 and instructions for use. Foreign manufacturers who don’t have a legitimate substance situated in Thailand should appoint a local representative to import the device.
Depending on the classification of your medical devices, Fundamental requirements for all classes of the medical device include a Certificate of Free Sale, a Certificate of a Quality Management System, for example, ISO 13485 and guideline for utilize.