The Thai Food and Drug Administration (FDA) recently implemented a new phase of its Medical Device Act. This phase is the transfer of some regulatory powers to the provincial governments. Thailand’s new Medical Device Act went into effect in 2008, overhauling Thailand’s regulatory system for devices, but the transfer of powers in the Act had been delayed.
Under the Medical Device Act, the Provincial Public Health Offices of Thailand’s 75 provinces have been granted various powers relating to the medical device business in their jurisdictions. These powers include issuing and revoking medical device distribution licenses. They can also order the cancellation of medical device advertisements that do not comply with the Medical Device Act. The Provincial Public Health Offices work under national guidelines in consultation with the Thai FDA.
This limited transfer of powers is intended to reduce regulatory costs to the medical device industry in Thailand, since it means medical device companies and branch offices outside of Bangkok do not need to travel to Bangkok as often. However, it could also pose problems if the Provincial Public Health Offices have a lower level of expertise than the Thai FDA.
It should be noted that the Thai FDA has said the Medical Device Act’s rules on advertising will be enforced strictly, and will cover anyone promoting a medical device to encourage a sale, even if they are not the party selling the device. Therefore, international medical device firms that promote their products in Thailand without actually distributing them (e.g., through representative offices) should also be familiar with the new law’s requirements, and be prepared to interact with the Thai Provincial Public Health Offices.
For the other regulatory changes in the Medical Device Act, please see our Asia Medical eNewsletter, Volume 8, Issue 6.