MoH: Ministry of Public Health MoH website: https://moph.gov.af/en Regulatory Authority: Afghanistan Food and Drug...
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How to place a device in the Northern Ireland market?
Under certain conditions, the UK MDR 2002 mandates that you notify the MHRA at the time of your device's initial sale...
UK Medical Device Registration Process
How to do medical device registration with the Medicines and Healthcare products Regulatory Agency (MHRA)? The...
Understanding Borderline Cosmetics in the EU
Understanding the distinctions between product classes within the European cosmetics landscape can be complex and...
Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK
Introduction and Guide to Market Access In the intricate landscape of medical device regulations, successfully...
Establish a Medical Device Startup Company
Introduction: Medical device startups play an essential role in revolutionizing patient care and improving quality of...
June Newsletter 2023
EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended...
Software As a Medical Device and Its Clinical Evaluation
As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely...
May Newsletter 2023
EUROPEAN UNION (EU) Updated MHRA guidance on significant changes under MDR | 12 May 2023 The guidance document MDCG...
April Newsletter 2023
Germany Database for In vitro diagnostics Medical Devices notification | 25 April 2023 In Vitro Diagnostic Medical...
Regulatory Services in China
OMC MedicalRegulatory ServicesSubscribeEU MDREU MDR, or the European Union Medical Device Regulation, is a new set of...
SFDA Classification of Medical Devices
The medical devices regulatory framework has a classification system for medical devices as per the classification...