Medical Device Regulatory Consultant in Chennai

Medfins International is a medical device regulatory consultant in Chennai, working from T. Nagar with a branch in Coimbatore. We help Tamil Nadu manufacturers, importers and distributors obtain CDSCO licences, ISO 13485 certification, CE marking and US FDA clearance, with a team you can meet in person.

Our Chennai office

Medfins International LLP
No: 8(14/2), First Floor, 70 Feet Road, Kaveri Nagar, T. Nagar, Chennai, Tamil Nadu 600015
Phone / WhatsApp: +91 85270 48221 · Email: sales@medfinsinternational.com
Monday to Saturday, 9:00 am to 6:00 pm IST

Coimbatore branch: S.No. 108, Sri Vignesh Nagar, Kumudham Nagar, Cheran Ma Nagar, Villankurichi, Coimbatore, Tamil Nadu 641035

CDSCO consultant in Chennai

Class A and Class B manufacturing licences are granted by the State Licensing Authority, so Tamil Nadu manufacturers work with the state drugs control administration as well as CDSCO. As a CDSCO consultant in Chennai, we prepare your Device and Plant Master Files, coordinate the notified body audit, file on the CDSCO portal and handle queries. We also support MD-15 import licences, MD-42 wholesale registration and test licences. Read our full guide to CDSCO registration for medical devices.

Medical device registration consultant in Chennai for global markets

Many Chennai and Coimbatore manufacturers export. Our team builds one technical file and adapts it for each market, which saves time and cost:

• CE marking consultant in Chennai – EU MDR and IVDR technical documentation, clinical evaluation and notified body support. CE marking services
• ISO 13485 consultant in Chennai – QMS design, documentation, internal audits and certification readiness. ISO 13485 certification
• US FDA – 510(k) submissions and establishment registration and listing
• Middle East and ASEAN – Saudi SFDA, UAE, Singapore, Malaysia, Thailand and the Philippines

How we work with Chennai and Coimbatore manufacturers

1. Discovery call or office visit to understand your device, intended use and target markets.
2. Classification and roadmap: the CDSCO class, licence forms, other markets and a realistic timeline.
3. Gap assessment at your plant covering the quality system, documentation and infrastructure.
4. Dossier and QMS build: Device and Plant Master Files, ISO 13485 procedures, risk management and validation.
5. Audit and submission support through notified body audits, CDSCO inspections and query responses.
6. Ongoing compliance through our annual maintenance contract, so licences, changes and renewals stay on track.

Device types we support

We support manufacturers and importers of surgical instruments and disposables, orthopaedic implants, diagnostic kits and analysers, patient monitoring and electro-medical equipment, dental products, wound care and hospital equipment. Each category has its own classification and evidence expectations, which we plan for from day one.

Why Tamil Nadu companies choose Medfins

• 175+ regulatory projects delivered across 250+ medical device products
• Face-to-face working sessions at your plant or our T. Nagar office
• Practical audit readiness for notified body and state inspections
• Our own MD-42 registered premises in Chennai for Indian authorised agent and import support

Book a consultation

Tell us about your device and target markets and we will map the licence route, documents and timeline. Contact our Chennai team or call +91 85270 48221.

Frequently asked questions