Medical Device & IVD Regulatory Consultants
Medical Device Regulatory Consulting for India and Global Markets
Medfins International helps medical device and IVD manufacturers, importers and businesses navigate complex regulatory pathways and access global markets — from CDSCO and ISO 13485 to CE marking, US FDA 510(k) and registrations across the Middle East and South-East Asia.
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
Bringing a medical device to market requires more than meeting individual regulatory requirements. It requires a clear regulatory strategy, strong quality systems, and a well-coordinated pathway from product development to market entry.
Medfins International supports medical device and IVD companies across these critical stages — helping them navigate regulatory requirements, prepare for submissions, obtain approvals and certifications, and maintain compliance across India and international markets.
With experience spanning 15+ countries and 250+ medical device and IVD products, we support companies entering the Indian market as well as Indian businesses expanding into global markets — providing regulatory expertise across key jurisdictions and market-access pathways.
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
Quality & Compliance
Not sure which services are right for your device?
Tell us about your product and target markets. We will help you identify the right regulatory pathway.
Book a consultation →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
“Simplifying regulatory pathways so medical technologies can reach the markets they are designed to serve.”
Arunkumar Chokkalingam leads Medfins International as a CQI & IRCA Certified ISO 13485 Lead Auditor, guiding MedTech companies through complex global regulatory landscapes.
He founded Medfins to bring regulatory thinking into projects early, and today the firm serves manufacturers, healthcare innovators and MedTech startups worldwide.
To support manufacturers, healthcare innovators and MedTech startups 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.