Registrations

MoH Ministry of Public Health MoH Website https://moph.gov.af/en Regulatory Authority Afghanistan Food and Drug Authority National Medicine and Health Products Regulatory Authority (NMHRA) Link for Regulatory Authority https://afda.gov.af/index.php/en/market-0 Afghanistan Drug Registration Procedure Pre-Market Afghanistan Drug Registration Procedure In the ever-changing healthcare landscape of Afghanistan, it is critical to effectively regulate medical goods and services. This paper explores the...

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.” The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III)....

Ministry of Health     Ministry of Health Regulatory Authority      National Agency for Medicines and Medical Devices of Romania (NAMMD) Medical Device Regulation          EU MDR 2017/745 EU IVDR 2017/746 Official Language     Romanian Classification of Medical Devices  Class I, IIa, IIb and III Registration Process 1. Determine the device classification 2. Appoint an Authorized Representative and Notified Body 3. The medical devices must be registered in the NAMMD da...

The Indonesian Food and Drug Authority (BPOM) plays a crucial role in ensuring the safety and efficacy of pharmaceuticals within the Republic of Indonesia. In 2019, the BPOM made a significant stride towards enhancing public services and aligning regulations with the evolving landscape of medicine. Regulation Number 15 of 2019 amended the existing Regulation Number 24 of 2017, specifically focusing on the criteria and procedures for drug registration. This amendment reflects a response to t...