About Us

About Medfins International

Medical device regulatory consultants who build compliance in from day one

Medfins International LLP is a medical device and IVD regulatory consultancy headquartered in Chennai, with a branch office in Coimbatore. We started with a simple observation: many good devices lose months, and significant budget, because regulatory requirements are discovered late in development or at the point of filing.

Our answer is to bring regulatory thinking into the project early — classification, standards, testing and quality system decisions made together — so that the technical file supports every market you plan to enter. Today we support manufacturers, importers and distributors with CDSCO licensing, ISO 13485 and MDSAP, CE marking, US FDA 510(k) and registrations across the Middle East and South-East Asia.

The team is led by Mr. Arunkumar Chokkalingam, Managing Director and a CQI & IRCA certified ISO 13485 Lead Auditor. Medfins International is a DPIIT-recognised Startup India company and holds its own CDSCO registration for the sale of medical devices.

Medfins International team with founder Arunkumar ChokkalingamTeam Medfins InternationalWatch our story

Our values

What guides every project

01

Accuracy before speed

We check every claim, test report and certificate against the applicable rules before filing. Getting it right first time is what saves time.

02

Transparency

Clear scope, honest timelines and regular updates. If a pathway carries risk, we tell you early and explain the options.

03

Partnership

We work as an extension of your quality and regulatory team, listening first and adapting to your products, markets and resources.

04

Continuous learning

Regulations change constantly. Our team tracks CDSCO, EU, US FDA and international updates so your documentation stays current.

What clients say

Client testimonials

Video testimonial: Mr. Johny, Sales Manager, 2L Bio Co., Ltd
Mr. JohnySales Manager, 2L Bio Co., Ltd
Video testimonial: Mr. Yoo Hwan Park and Mr. Dal-Won Kim, Vassen Colour Contact Lenses
Mr. Yoo Hwan Park & Mr. Dal-Won KimVassen Colour Contact Lenses
Video testimonial: Mr. Appasamy Shanmugam, Managing Director, Lub Dub Medical Technologies Pvt. Ltd.
Mr. Appasamy ShanmugamManaging Director, Lub Dub Medical Technologies Pvt. Ltd.
Video testimonial: Mr. Ayyappan, Director, 3G Surgical Industries Pvt Ltd
Mr. AyyappanDirector, 3G Surgical Industries Pvt Ltd
Video testimonial: Mr. Sayad Samuela, Sales Manager, Mycro Healthcare
Mr. Sayad SamuelaSales Manager, Mycro Healthcare
Video testimonial: Dr. Subramaniyan, CEO, Venticare Medical Pvt Ltd
Dr. SubramaniyanCEO, Venticare Medical Pvt Ltd
Video testimonial: Mr. Jitendra Singh Parihar, Founder and CEO, Medixa Global LLP
Mr. Jitendra Singh PariharFounder & CEO, Medixa Global LLP
Video testimonial: Mr. Prateek Chandra, Managing Director, Gasair Multitech LLP
Mr. Prateek ChandraManaging Director, Gasair Multitech LLP
Video testimonial: Mr. Venkat, Director, Sri Vathsa Medi Systems Private Limited
Mr. VenkatDirector, Sri Vathsa Medi Systems Private Limited
Video testimonial: Dr. Shanmugam S., Proprietor, Coldchain Controls
Dr. Shanmugam S.Proprietor, Coldchain Controls

What people speak

★★★★★
We are the authorized distributor of Contec and Amoul in South India. With the valuable guidance of Mr. Arun, we successfully obtained our import license within the expected timeline. The process was smooth and well-managed, ensuring compliance with regulatory requirements. We are now planning to pursue ISO 13485 certification and a manufacturing license to further expand our operations. I highly appreciate the professionalism and expertise provided and would strongly recommend your services.
Mr. PrakashDirector, Mycro Healthcare
★★★★★
We are manufacturers of sterile surgical drapes, urine containers, and a range of other Class A and B medical devices. We recently obtained ISO 13485 certification and the MD-5 license, marking a significant milestone in our commitment to quality and regulatory compliance. The entire process was efficiently managed, with clear guidance at every step, ensuring a seamless and hassle-free experience. The expertise and support we received played a crucial role in navigating the regulatory requirements with confidence. We look forward to collaborate on future projects as we continue to grow and excel in the industry.
Mr. P.A. AyyappanDirector, 3G Surgical Industries Pvt Ltd
★★★★★
We selected Medfins International as our Indian Authorized Agent for our medical device. Their communication was clear and concise throughout the process. The services they provided were of high quality and met our expectations. We would definitely recommend their services to others.
Soo Yan CheongRegulatory Manager, Hannah Life Technologies Pte Ltd (Singapore)
★★★★★
We have collaborated with Medfins International for ISO 13485 compliance. My experience with their service was outstanding. I highly appreciate the professionalism and efficiency displayed. I would gladly give a high rating and confidently recommend your services to others. Keep up the excellent work.
PratibaQuality Manager, Neuome Technologies Pvt Ltd
★★★★★
As an importer of dermatological lasers and cosmetics, we have successfully obtained the COS-2 certification and are currently in the process of securing our import license for Class C products. Additionally, we are preparing to apply for licenses for more products as we expand our portfolio. Mr. Arun and his team were incredibly supportive throughout the process, their expertise has been invaluable, and we look forward to continuing our collaboration for future regulatory requirements.
Mr. Shyam PartibanDirector, Sensdermics Healthcare Pvt Ltd
★★★★★
I’m delighted to share my experience with Medfins International. Their expertise and guidance were instrumental in helping Medixa Global LLP achieve ISO 13485 certification. The team at Medfins International provided us with clear and concise information, tailored their approach to our specific needs, and supported us throughout the certification process. Their dedication and professionalism ensured we met all the requirements and passed the certification audit successfully. I highly recommend Medfins International to any organization seeking to implement a robust quality management system.
Mr. Jitendra Singh PariharFounder & CEO, Medixa Global LLP
★★★★★
I sincerely appreciate Medfins International LLP, especially Ms. Aishwarya S.M., for their exceptional professionalism and support throughout our CDSCO registration process. Aishwarya is an incredibly dedicated and highly skilled Regulatory Affairs specialist—her quick responses, clear guidance, and accurate insights made even complex requirements easy to navigate. Thanks to her consistent support, our India registration progressed smoothly and confidently. I highly recommend Medfins International LLP for reliable and expert RA support in India.
Mr. Lee, Kyeong-RoFounder & CEO, 2L Bio Co., Ltd