إجراء مقترح من تايلاند: الأجهزة والمستلزمات الطبية

The Minister of Public Health hereby issues the draft Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for the Use of Medical Devices in Clinical Investigations B.E..... This draft Notification repeals the Notification of the Ministry of Public Health Re: Rules, Procedures and Conditions for the Use of Medical Devices in Clinical Investigations B.E. 2566 (2023). This draft Notification shall apply to the following: 1. Class 4 medical devices 2. All implantable medical devices and long-term surgically invasive medical devices 3. Novel medical devices not previously registered in any country 4. Medical devices defined by the Secretary-General of the Food and Drug Administration 5. Class 2 and Class 3 medical devices with novel indications not previously registered in any country This draft Notification provides definitions of terms including ‘clinical investigation’, ‘analytical performance study’, ‘investigational medical device’, ‘clinical investigation plan’, ‘sponsor’, ‘investigator’, ‘serious adverse event’, and ‘adverse device effect’. In addition, it prescribes requirements for manufacturers, importers, investigators and sponsors, as well as a transition period for persons who have manufactured or imported medical devices for clinical investigation and for those currently conducting clinical investigations.