EU MDR & IVDR Targeted Revision 2025 What Is Changing, Why It Matters, and How Manufacturers Should Prepare?
Category: Regulatory
CDSCO Import License (MD-15) & Test License (MD-16): The Complete Guide to India Market Entry
Deciphering the CDSCO Forms: Import License (MD-15), Test License (MD-16), and the Sugam Portal
The CDSCO registration process is centralized through the official Sugam Portal, which is the dedicated online platform for all applications. This process revolves around specific forms required for various purposes, including obtaining the Import License (MD-15) and Test License (MD-16). Confusion over these forms is the number one reason for regulatory setbacks.
It is also important to note the National Single Window System (NSWS) (https://www.nsws.gov.in/). This initiative aims to streamline and simplify investment and business clearances across various Indian government departments, potentially integrating future CDSCO-related approvals and making the entire process more efficient for foreign investors and domestic manufacturers.
Understanding 21 CFR Part 820: FDA Quality System Regulation Requirements
Demystifying 21 CFR Part 820: A Guide to the Quality System Regulation Table of Contents Introduction Subpart A:
Understanding QSMR 21 cfr 820
The Shift to QMSR: An Interactive Infographic The Shift to QMSR Navigating the FDA’s New Quality Management System
EU AI Act Compliance Infographic
EU AI Act: Your Path to Compliance Navigating the EU AI Act A visual guide to assessing your
Essential List of Applicable Standards (LOAS) for Medical Devices | Regulatory Compliance Guide
Infographic: Finding FDA Recognized Standards Mastering the FDA Standards Database A visual guide to finding recognized consensus standards
How to Find a Predicate Device: A Step-by-Step Guide for FDA 510(k) Clearance
Infographic: Finding a Predicate for FDA 510(k) Submission Navigating the 510(k) Pathway Your expert guide to identifying the
The Strategic FDA Submissions: A Guide to 510(k), PMA, and De Novo Pathways
Executive Summary: Navigating the U.S. Medical Device Regulatory Landscape The U.S. Food and Drug Administration (FDA) employs