Medical Device & IVD Regulatory Consultants
Medical Device Regulatory Consulting for India and Global Markets
Medfins International helps medical device and IVD manufacturers, importers and distributors secure and maintain approvals — CDSCO licences, ISO 13485 certification, CE marking, US FDA 510(k) and registrations across the Middle East and South-East Asia — with one accountable team from strategy to approval.
175+
Regulatory projects delivered
250+
Medical device products
100+
Clients served
15+
Countries covered
About Medfins International
A regulatory partner that takes your device from dossier to market
A strong product can still lose months to an incomplete dossier or an unexpected regulator query. Medfins International brings regulatory strategy, quality systems and submission preparation under one roof, so manufacturers get a clear pathway, complete documents and fewer surprises.
From our offices in Chennai and Coimbatore, we support Indian manufacturers expanding abroad and overseas manufacturers entering India — across more than 15 countries and 250+ medical device and IVD products.
Our Services
Medical device regulatory services, end to end
Licensing, quality systems and international registrations for medical devices and IVDs — planned together, so one set of documents works harder across every market.
India Licensing (CDSCO)
CDSCO Manufacturing Licence
End-to-end support for MD-3 and MD-7 applications, from device classification and master files to audit readiness and grant of licence.
Learn more →CDSCO Import Licence
MD-14 applications and MD-15 import licences for overseas medical device and IVD manufacturers, prepared and managed by one regulatory team.
Learn more →Indian Authorised Agent
Guidance for overseas manufacturers on appointing and working with an Indian authorised agent for CDSCO licensing and post-market duties.
Learn more →CDSCO Test Licence
Test licences in Form MD-13 and MD-17 to make or import medical device samples for testing, evaluation, clinical investigation or training.
Learn more →Wholesale Registration (MD-42)
MD-41 applications and MD-42 registration certificates for traders, distributors and retailers who sell, stock or distribute medical devices.
Learn more →BIS Licence & ISI Mark
BIS product certification and ISI mark licences for medical and hospital products made in India or overseas, from standard mapping to grant.
Learn more →GeM Registration
GeM seller registration, OEM brand approval, vendor assessment and catalogue support for medical device and IVD manufacturers and distributors.
Learn more →Quality & Compliance
ISO 13485:2016 Certification
Build, implement and certify a medical device QMS to ISO 13485:2016 that also meets CDSCO, EU MDR and US FDA QMSR expectations.
Learn more →MDSAP Certification
Prepare for a Medical Device Single Audit Program audit that satisfies the USA, Canada, Australia, Brazil and Japan in one QMS audit.
Learn more →Internal Audit Support
Independent ISO 13485 internal audits, mock regulatory audits and CAPA follow-up by experienced medical device QMS auditors.
Learn more →Supplier Audit Support
On-site and remote audits of critical suppliers and contract manufacturers, with supplier qualification and quality agreement support.
Learn more →Training & Workshops
Practical training on ISO 13485, ISO 14971, CDSCO MDR 2017, EU MDR / IVDR, internal auditing and CAPA, delivered in-house or online.
Learn more →Annual Maintenance Contract
An annual regulatory retainer covering licence upkeep, post-approval changes, PMS and vigilance, audit readiness and regulatory updates.
Learn more →Outsourced Regulatory Staff
Dedicated or shared regulatory affairs and QA professionals on contract, on-site or remote, to run your medical device compliance work.
Learn more →Global Market Access
CE Marking (EU MDR / IVDR)
CE marking support under EU MDR 2017/745 and IVDR 2017/746: classification, technical documentation, notified body liaison and EUDAMED.
Learn more →US FDA 510(k)
End-to-end US FDA 510(k) support: predicate strategy, eSTAR preparation, testing plans, registration, listing and US Agent coordination.
Learn more →UAE (MOHAP / EDE)
UAE medical device registration with the Emirates Drug Establishment (formerly MOHAP): classification, dossier and local representative support.
Learn more →Saudi Arabia SFDA
Saudi SFDA medical device registration support: MDMA dossiers on GHAD, Saudi Authorised Representative coordination, MDNR listing and MDEL guidance.
Learn more →Egypt EDA
Egypt EDA medical device and IVD registration support: classification, dossier preparation, CFS legalisation and coordination with your local agent.
Learn more →Sri Lanka NMRA
Sri Lanka NMRA medical device registration support: local agent set-up, product dossiers, site approval, reliance route and import licensing.
Learn more →Singapore HSA
Singapore HSA medical device registration support: classification, route selection, CSDT dossiers, SHARE submissions and dealer’s licences.
Learn more →Thailand FDA
Thailand FDA medical device registration support covering Class 1 to 4 classification, CSDT dossiers and your Thai licence holder.
Learn more →Philippines FDA
Philippines FDA medical device registration support: CMDN and CMDR applications, LTO checks, CSDT dossiers and CDRRHR query handling.
Learn more →Malaysia MDA
Malaysia MDA medical device registration support: classification, CAB conformity assessment, CSDT dossiers, MeDC@St and authorised representative.
Learn more →Why Medfins International
Lead auditor-led expertise
Projects are directed by a CQI & IRCA certified ISO 13485 Lead Auditor, so your QMS and submissions are prepared the way auditors and regulators review them.
One team for India and global markets
CDSCO, EU MDR/IVDR, US FDA, Middle East and ASEAN registrations handled by one coordinated team, reusing a single dossier strategy wherever regulators allow.
Three-level document review
Every dossier passes preparation, technical review and final compliance checks against the applicable rules before filing, to reduce queries and resubmissions.
Confidential by design
Technical files are handled under ISO 27001-aligned information security controls and signed confidentiality agreements.
Clear milestones and reporting
Defined scope, a named consultant and regular status updates, so you always know where your application stands.
Support after approval
Retention, renewals, post-approval changes, vigilance and audits through annual maintenance contracts and outsourced regulatory staff.
Meet Our Director
Mr. Arunkumar Chokkalingam
Managing Director, Medfins International · CQI & IRCA Certified ISO 13485 Lead Auditor
Mr. Arunkumar Chokkalingam is a distinguished professional in the field of medical device regulatory affairs and quality management systems, recognized for his expertise in guiding MedTech companies through complex global regulatory landscapes. As a CQI & IRCA Certified ISO 13485 Lead Auditor, he has dedicated his career to helping medical device manufacturers achieve regulatory compliance, quality excellence, and successful international market access.
With deep industry knowledge and hands-on regulatory experience, he specializes in CDSCO registrations, EU MDR compliance, USFDA 510(k) submissions, MDSAP certification, ISO 13485 implementation, and regulatory strategies for medical devices and IVD products. His practical and solution-oriented approach enables organizations to navigate evolving regulatory requirements with confidence and efficiency.
Driven by a vision to simplify regulatory pathways for the healthcare industry, he founded and built Medfins International into a trusted regulatory consulting company serving manufacturers, healthcare innovators, and MedTech startups worldwide. Through his leadership, Medfins International continues to support organizations in bringing safe, effective, and compliant medical technologies to global markets.
Client Testimonials
Hear it from our clients
We had an excellent experience working with Medfins International for our regulatory requirements. Their team provided outstanding support throughout our CDSCO approval process, ensuring smooth documentation, clear regulatory guidance, and timely coordination, which enabled a seamless entry into the India market.Mr. JohnySales Manager, 2L Bio Co., Ltd
We are proud to have supported Vassen Colour Contact Lenses throughout their CDSCO regulatory process and MD-15 Import Licence journey. We sincerely thank Mr. Yoo Hwan Park, Executive Director, and Mr. Dal-Won Kim, Sales Manager & Regulatory Affairs Specialist, for sharing their valuable feedback and placing their trust in Medfins International LLP.Mr. Yoo Hwan Park & Mr. Dal-Won KimVassen Colour Contact Lenses
We are proud to have supported Lub Dub Medical Technologies Pvt. Ltd. throughout their regulatory journey with expert guidance and comprehensive regulatory support. We sincerely thank Mr. Appasamy Shanmugam, Managing Director, for sharing his valuable feedback and placing his trust in Medfins International LLP.Mr. Appasamy ShanmugamManaging Director, Lub Dub Medical Technologies Pvt. Ltd.
Medfins has delivered exceptional service, handling every aspect of the regulatory process with dedication and precision. They’ve become one of our most trusted partners, and we look forward to working with them on all our upcoming projects. Thank you to the entire Medfins team — especially our dedicated partner, Akshaya, for her outstanding support throughout.Mr. AyyappanDirector, 3G Surgical Industries Pvt Ltd
From paperwork to approvals, Medfins turned complexity into confidence. 11 licenses, zero delays — a partnership we trust without question.Mr. Sayad SamuelaSales Manager, Mycro Healthcare
Though we entered the regulatory space later than many competitors, partnering with Medfins International LLP changed our game entirely. With the expert guidance of Mr. ArunKumar Chokkalingam, we’ve not only caught up — we’ve surged ahead.Dr. SubramaniyanCEO, Venticare Medical Pvt Ltd
We are grateful to Medfins International, especially Arun and Sneha, for their exceptional support throughout our regulatory journey. As the first manufacturer of dental sedation system, we faced extensive documentation requirements. Thanks to Arun and Sneha, we successfully obtained the CDSCO license and are now planning for CE marking.Mr. Jitendra Singh PariharFounder & CEO, Medixa Global LLP
We partnered with Medfins International for ISO 13485, CDSCO, and multiple certification needs. Thanks to Sneha and Arun for their support and clear guidance throughout the process.Mr. Prateek ChandraManaging Director, Gasair Multitech LLP
We are grateful to Medfins International for their exceptional support throughout our CDSCO certification journey. From handling complex documentation to guiding us seamlessly through the audit process, their expertise and dedication were truly commendable. We would like to extend our sincere thanks to Mr. Arun Kumar for his valuable financial support and continuous encouragement, which played a crucial role in achieving our regulatory approval successfully.Mr. VenkatDirector, Sri Vathsa Medi Systems Private Limited
We are honoured to have supported Coldchain Controls throughout their CDSCO regulatory process and MD-5 Manufacturing License journey. We sincerely thank Dr. Shanmugam S., Proprietor of Coldchain Controls, for sharing his valuable feedback and placing his trust in Medfins International LLP.Dr. Shanmugam S.Proprietor, Coldchain Controls
Trusted by 100+ MedTech companies
Our Few Clients
Frequently asked questions
Medical device regulatory FAQs
What does a medical device regulatory consultant do?
Which licence do I need to sell medical devices in India?
Can an overseas manufacturer register devices in India?
How long does a CDSCO medical device licence take?
Do you support registrations outside India?
How do you protect our technical documents?
Latest News & Blogs
Regulatory insights from our team
- MDSAP and EN ISO 13485: One Audit, Five Markets
MDSAP explained: the five participating authorities, why Canada makes it mandatory, why the EU does not accept it, the seven-process audit model, the 2026 changes, and how EN ISO 13485 differs from ISO 13485. - Indian Authorised Agent for Medical Devices: CDSCO Guide
What an Indian Authorised Agent does under the Medical Devices Rules 2017, the MD-14 to MD-15 pathway, agent liability, and why appointing your distributor as agent can cost you the Indian market. - EU IVDR 2017/746: Compliance Guide for IVD Manufacturers
EU IVDR 2017/746 explained: Annex VIII classification, transition deadlines to 2029, performance evaluation under Annex XIII, Class D obligations and EUDAMED registration.