• Telphone : (+91) 85270 48221
  • sales@medfinsinternational.com
Medfins International - Medfins InternationalMedfins InternationalMedfins International

  • Home
  • About Us
    • Gallery
    • Certifications
    • Testimonials
  • Services
    • ISO 13485
    • CE Marking
    • US FDA 510(k) Submission
    • Indian Authorised Agent
    • Medical Device Single Audit Program (MDSAP)
    • GEM Registration & Vendor Assessment
    • BIS (CRS) – License
    • ISI – MARKING
    • Wholesale Licence
    • CDSCO Testing Licence
    • CDSCO Manufacturing licence
    • CDSCO Import Licence
  • Insights
    • Blog
  • Contact

Monthly Archives: October 2025

Medfins International > 2025 > October
09
Oct
Date October 9, 2025
Author Ms. Sneha Ramasamy

Post-Approval Changes in Medical Devices under CDSCO

Introduction Medical devices continue to evolve even after they receive regulatory approval. Manufacturers frequently implement i...
Read More
0 Comments Author Ms. Sneha Ramasamy

Categories

  • Blog 33

Recent Posts

  • Diagram of the MDSAP audit pathway showing six steps from ISO 13485 quality management system foundation through gap analysis, selecting a recognised Auditing Organisation, the two-stage seven-process audit, findings grading and certification covering five marketsMDSAP and EN ISO 13485: One Audit, Five MarketsSeptember 4, 2026
  • Diagram of the Indian Authorised Agent pathway for CDSCO medical device import showing six steps from appointing a licensed Indian agent and power of attorney through classification, Form MD-14 application via SUGAM, CDSCO review and grant of the Form MD-15 import licenceIndian Authorised Agent for Medical Devices: CDSCO GuideSeptember 4, 2026
  • Diagram of the EU IVDR 2017/746 compliance pathway showing six steps from Annex VIII classification through quality management system, performance evaluation, notified body assessment, EUDAMED registration and CE marking, with legacy device transition deadlines to 2029EU IVDR 2017/746: Compliance Guide for IVD ManufacturersSeptember 4, 2026
  • Diagram of the EU MDR 2017/745 compliance pathway showing six steps from Annex VIII classification through quality management system, technical documentation, notified body conformity assessment, EUDAMED registration and CE marking, with the 2027 and 2028 transition deadlinesEU MDR 2017/745: Compliance Guide for Manufacturers (2026)September 4, 2026
  • Diagram of the US FDA 510(k) submission pathway showing six steps from device classification and predicate selection through eSTAR submission, FDA review and substantial equivalence clearance, with FY2026 user feesUS FDA 510(k) Submission: The Complete 2026 GuideSeptember 4, 2026

Archives

  • September 2026
  • April 2026
  • October 2025
  • May 2025
  • April 2025
  • February 2025
  • January 2025
  • December 2024
  • November 2024
  • October 2024
  • September 2024
  • August 2024
  • July 2024
  • May 2024
  • April 2024
  • March 2024
  • February 2024
  • January 2024
  • November 2023
  • October 2023
We encourage positive, fun and authentic collaboration, while placing a high value on people.

GSTIN : 33ABYFM7261L1ZH
MD 42 : TN/Z03/MD42/00053
DIPP152468

OUR SERVICES

  • ISO 13485
  • Indian Authorised Agent
  • Wholesale Licence
  • MDSAP
  • BIS (CRS) – Licence
  • US FDA 510(k) Submission
  • CDSCO Testing Licence
  • CDSCO Manufacturing licence
  • CDSCO Import Licence
  • CE Marking

Corporate Office:

  • No: 8(14/2), First Floor, 70 Feet Road, Kaveri Nagar, T. Nagar, Chennai - 600015, Tamil Nadu.
  • +91 8527048221
  • sales@medfinsinternational.com

Branch Office:

  • S.NO. 108, Sri Vignesh Nagar, Kumudham Nagar, Cheran ma Nagar, Villankurichi, Coimbatore, Tamil Nadu 641035
  • +91 8527048221
  • sales@medfinsinternational.com
Copyright © 2026 Medfins International. All rights reserved.