Registration
Iraq Medical Device Registration: KIMADIA Guidelines and Requirements
Navigating Medical Device Registration with Iraq's Regulatory Authority: KIMADIA Guidelines and Requirements Regulatory Authority: State Company for Marketing Drugs and Medical Appliances...
Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
TFDA Requirements for Summary Product Characteristic (SPC) Name of the Medical Product Qualitative And Quantitative Composition Pharmaceutical Form Clinical Particulars Therapeutic...
Overhauling Drug Registration: The Indonesian Food and Drug Authority’s Progressive Amendment
Drug Registration - 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...
Comprehensive Guide to Pharmaceutical Registration in Indonesia: BPOM, Regulations, and Approval Pathways
Territory: Southeast Asia Official Language: Indonesian/English Regulatory Authority Name: Badan Pengawas Obat dan Makanan (BPOM) Regulatory Authority website:...
Comprehensive Guide to Medicinal Product Registration in Armenia: Criteria, Procedures, and Quality Standards
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:...
Streamlining Pharmaceutical Registration in Argentina: A Comprehensive Guide to Navigate the Regulatory Process for Drug Approval
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...
Demystifying Pharmaceutical Registration in Albania: Your Ultimate Guide to Medicine, Drug, and OTC Product Approval Processes
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...
Streamlining the Afghanistan Drug Registration: A Comprehensive Guide for Approval and Compliance
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...
MDCG Guidance for Manufacturers of Class I Medical Devices
This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market in order to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.
Requirements of Technical Documentation EU MDR
The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner. It shall include all the elements listed in Annex II of EU MDR.
“Professional use” Test Kit – Procedure for registration in UK
"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...
Labelling Requirements
Economic Operator Swiss EU UK AR/RP CH REP on the product label. Name and Address of the registered place of business. OMC Swiss AR Address: OMCS Medical Gmbh C/O Mr Wilhelm Gudelow...
Labelling Requirements – Swiss Authorized Representative
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...
MEDICAL DEVICE REGISTRATION IN ROMANIA
How OMC Medical can assist you with MEDICAL DEVICE REGISTRATION IN ROMANIA? Act as your Romanian AR Help you with the Romanian registration by filling in the form and registering the medical device...