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Regulatory Resources & Updates

Guidance documents, regulatory updates, and reference materials covering CDSCO, EU MDR/IVDR, US FDA, ISO standards and more, curated for medical device and healthcare professionals.

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Showing 12 resources
DateTitle / DescriptionCategoryTypeDownload
Jun 2025
Medical Devices Rules 2017: Consolidated TextCDSCO consolidated MDR 2017 including all amendments
CDSCO
Regulation
⬇ PDF
May 2025
Wholesale Licence (MD-42): Application GuidanceStep-by-step checklist for wholesale distributor licence
CDSCO
Guidance
⬇ PDF
May 2025
Import Licence (MD-14): Application ChecklistDocument requirements for medical device import licence
CDSCO
Checklist
⬇ PDF
Apr 2025
Investigational Device Permission (MD-26): OverviewRequirements and pathway under MDR 2017
CDSCO
Guidance
⬇ PDF
Mar 2025
EU MDR 745: Summary of Key RequirementsOverview of essential requirements under EU Medical Device Regulation
EU MDR
Summary
⬇ PDF
Feb 2025
EU IVDR 746: Classification & Transition TimelinesIVD classification rules and updated transition timeline guidance
EU IVDR
Guidance
⬇ PDF
Jan 2025
Post-Market Surveillance: PMS / PMCF / PSUR RequirementsPractical guidance on post-market obligations under EU MDR
EU MDR
Guidance
⬇ PDF
Dec 2024
US FDA 510(k): Submission Pathway OverviewKey requirements and process for 510(k) premarket notification
US FDA
Guidance
⬇ PDF
Nov 2024
FDA QMSR / 21 CFR 820: Key Changes SummaryComparison of QMSR against legacy QSR and ISO 13485 alignment
US FDA
Summary
⬇ PDF
Oct 2024
ISO 13485:2016, Key Clauses Reference GuideQuick reference to clause requirements and audit focal points
ISO
Reference
⬇ PDF
Sep 2024
ISO 14971: Risk Management for Medical DevicesOverview of risk management process requirements
ISO
Reference
⬇ PDF
Aug 2024
Global Regulatory Landscape: Medical Devices 2025Comparative overview: India, EU, USA, Japan, Brazil regulatory frameworks
General
Article
⬇ PDF