Registrations

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:     Class I, IIa, IIb and III Registration Process: Document...

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)....

“Professional use” Test Kit – Procedure for registration in UK  Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since the year 2020. One of the most difficult aspects of coronavirus is the ambiguity of not knowing who has been infected or whether it is safe to resume normal activities. Testing of high quality might assist provide assurance. However, no good thing...

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745. Requirements of Technical Documentation as per Annex II Device Description and Specification, including variants...

A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III.  This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union mar...

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....

MoH: The Ministry of Health and Social Protection. MoH website: https://shendetesia.gov.al Regulatory Authority: National Agency for Medicines and Medical Devices (AKPBM) Link for Regulatory Authority: https://akbpm.gov.al/ Medicine/Drug/OTC/Pharmaceutical Registration in Albania The Agency for Medicinal Products and Medical Devices (AMPMD) is responsible for overseeing the drug registration process in Albania. Here is a general outline of the drug registration process: 1. Pr...

MoH: Ministry of Health of Argentina MoH website: https://www.argentina.gob.ar/salud Regulatory Authority: The National Administration of Drugs, Food and Medical Technology Link for Regulatory Authority: https://www.argentina.gob.ar/anmat Applicable Regulation: DECREE NO. 150/1992 ESTABLISHES THE RULES FOR THE REGISTRATION, PREPARATION, DIVISION, PRESCRIPTION, SALE, MARKETING, EXPORT AND IMPORT OF MEDICINES. Biologics/Drugs/Pharmaceutical/Medicine/OTC- general registrati...

MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Regulatory Authority: Scientific centre of drug and medical technology expertise Link for Regulatory Authority: https://www.pharm.am/index.php/en/ Overview The registration of medicinal products in the Republic of Armenia involves adherence to a set of stringent requirements outlined in various legislative acts. The fundamental legal framework comprises the Laws of the Republic of Armenia, specifi...