Introduction to UK Conformity Assessed (UKCA): Requirements
UK Conformity Assessed (UKCA) is the United Kingdom’s product marking introduced on 1 January 2021 after Brexit. UKCA shows that a product meets the health, safety, and environmental protection standards required by UK law. It applies to goods sold in Great Britain...
How to Transition from MDD to MDR? 5 Core Steps
European Union Medical Device Regulation (EU MDR) has replaced the previous Medical Device Directive (MDD). It aims to address gaps in oversight and improve patient safety. EU MDR introduces stricter requirements for clinical evaluation, post-market surveillance,...
How to Start a Nebulizer Manufacturing Unit in India?
In this blog, we have prepared a detailed guide on how to set up a nebulizer manufacturing facility in India. To start a nebulizer manufacturing unit in India, you must comply with CDSCO’s Medical Device Rules, 2017. Additionally, you need to secure the CDSCO license...
Health Canada Regulatory Pathways for IVDs: Complete Guide
Health Canada regulates in vitro diagnostic devices (IVDs) under the Medical Devices Regulations. It uses a risk-based classification system (Class I–IV) to determine the applicable regulatory pathways. Class II–IV IVDs require a Medical Device Licence (MDL). On the...