The Thai FDA speeds up issuing the notification of medical devices, aiming to set up the requirement for the controller of the medical devices manufacture, importation and sales as well as to improve the procedures on medical devices permission to gain facilitation and fast services to response the mobilization of the wellness economy with the awareness of quality control, efficiency and safety of medical device.

 On 25 March 2024, Dr. Surachoke Tangwiwat, Deputy Permanent Secretary of the Ministry of Public Health, was the chair of the Commission on Medical Devices Meeting 3/2567, together with Dr. Narong Aphikulvanich, the Secretary-General, Mr. Lertchai Lertvut, the Deputy Secretary-General, of the Food and Drug Administration and the representatives from

the concerned organizations jointly considered the draft on Medical Devices Law as follows:
1. (Draft) The Notification of the Ministry of Public Health Re: the medical devices which specify the arrangement for the controller of the medical devices manufacture, importation and sales and quality, quantity, and roles of the controller B.E…. The key concern of the Notification stipulates that the registrants for the establishment, permission grantee of the licensed medical device, the notified medical device and the listed medical device of manufacture or importation shall provide for the controller of production or importation of the medical devices including the permission grantee for the sale of medical devices shall arrange for the controller of medical devices sale and carry out the quality, quantity, and roles of the controller.
2. (Draft) The Notification of the Food and Drug Administration Re: the criteria, method, and condition on the evaluation of the technical documents, the testing, the inspection of the establishments or the consideration of granting the medical devices permission B.E…. The key concern of the Notification is about to reduce the process of granting the medical devices permission which covers the evaluation of the technical documents and the inspection of the establishments by the adaptation of the technology on remote inspection, except in the case of the reasonable doubt on the quality, efficiency and safety.

The Food and Drug Administration (FDA) places the greater emphasis on mobilizing the wellness economy policy. Therefore, FDA has accelerated to issuing the law on medical devices in order to improve the procedures on granting permission to provide facilitation, fast service, and strengthen measures aimed at protecting consumers through the control of medical devices production, importation and sale that needs to have the system for quality, efficiency and safety, which results in promoting the sustainable expansion of the medical devices industry.

                                                                                        ………………………………………………….
                                                                                       News Publication Date: 25 March 2024