Thai and Singapore FDAs Expedite Regulatory Process-Reduce Time to Register for Medical Devices
12 March 2024

            The Thai Food and Drug Administration (FDA) has formed a partnership with the Health Science Authority (HSA), in Singapore to establish the Reliance Program. The initiative's aim is to facilitate entrepreneurs by reducing the steps, time and costs associated with developing regulatory processes for medical devices and effective consumer protection.

           Mr. Lertchai Lertvut, the Deputy General-Secretary of the FDA, has disclosed that the FDA has cooperated with the HSA, which is the health products regulatory authority in Singapore, to implement the Thai FDA & Singapore HSA Regulatory Reliance project on medical devices. Registered medical devices with the HSA can apply for registration with the Thai FDA in accordance with the Reliance Program, which is designed to facilitate manufacturers or importers by reducing the number of steps and the duration of registration, as well as expert fees for the registration. This represents productive cooperation between the two agencies in the registration of medical devices. In addition, discussions were held to expand other potential cooperation beyond registration, such as post-marketing control of medical devices, to regulate the medical devices throughout their life cycle. The international cooperation between these two agencies will help  ensure that people have access to products with quality and standards that are accepted internationally. Such cooperation will also enhance consumer protection and public confidence, ensuring that the Thai people are protected from unsafe medical device products. 

(Link for more details: Thailand FDA - HSA Singapore Regulatory Reliance)

                                                                    News Publication Date: 12 March 2024