Choosing a medical device regulatory consultant in India decides how fast your CDSCO licence, CE certificate or FDA clearance arrives, and how many costly queries you face on the way. This guide lists established medical device regulatory consulting firms operating in India, what each one focuses on and how to choose between them.
Disclosure: this guide is published by Medfins International, which is one of the firms listed. We have listed ourselves first. Other firms are described only from information on their own public websites (checked 31 October 2026). The list is not a quality ranking; contact firms directly to confirm current services.
How to choose a medical device regulatory consultant
- Device and market fit: ask for recent projects with your device class and type (for example Class C implants, IVD kits or software) and your target markets.
- India licensing depth: for India, check hands-on experience with the CDSCO online portal, MD-5/MD-9 manufacturing licences, MD-15 import licences, notified body audits and query responses.
- Indian authorised agent capability: overseas manufacturers need an agent with a valid wholesale licence or MD-42 registration, plus systems for complaints, vigilance and recalls.
- Export capability: if you will sell abroad, one team that also handles ISO 13485, CE marking, US FDA and Middle East or ASEAN registrations avoids rebuilding your technical file.
- Transparent scope and fees: ask for a written scope, government fees separated from consulting fees, and a fixed fee where possible.
- Confidentiality: sign an NDA before sharing design or manufacturing data.
Medical device regulatory consultants in India at a glance
| Firm | Based in | Main focus | Often a fit for |
|---|---|---|---|
| Medfins International | Chennai (T. Nagar), Coimbatore branch | CDSCO licences (MD-5, MD-9, MD-15, MD-42), Indian Authorised Agent, ISO 13485, MDSAP, CE marking (EU MDR/IVDR), US FDA 510(k) and registration, Saudi SFDA, UAE, Egypt and ASEAN registrations | Manufacturers who want one team for India plus export markets, and overseas makers needing an Indian authorised agent |
| CliniExperts | New Delhi | Regulatory services across drugs, medical devices, IVDs, cosmetics and food, including importer and manufacturer licensing | Companies with products in several regulated categories |
| Freyr Solutions | Global, with an India office in Hyderabad | Regulatory solutions and operations for pharma, medical devices and consumer health | Large companies running regulatory work across many countries |
| Morulaa HealthTech | Chennai | Medical device and IVD regulatory consulting, India market access and Indian authorised agent services, global registrations | Overseas device and IVD makers entering India |
| Operon Strategist | Pune | Medical device product development, turnkey manufacturing facility set-up, regulatory compliance and global registrations | New manufacturers building a plant as well as getting licences |
| I3CGLOBAL | Offices in Bengaluru, Delhi and Kochi | EU MDR and IVDR CE marking, US FDA 510(k), FDA QMSR and ISO 13485 | EU and US submissions |
| Maven Profcon Services | Ahmedabad | CE marking under EU MDR/IVDR, US FDA 510(k), CDSCO approvals, ISO 13485 and UKCA | Exporters targeting Europe and the US |
| Elexes Medical Consulting | US-headquartered, with an office in Bengaluru | EU MDR, US FDA submissions, ISO 13485, TGA and UK regulatory work | Companies focused on US and EU markets |
| Artixio | India-based, multi-country network | Regulatory affairs across many countries, CDSCO medical device services and a regulatory intelligence product | Multi-country registration programmes |
| HL Associates | Ahmedabad | CDSCO licensing, US FDA, EU MDR, UKCA and ISO 13485 | Gujarat-based manufacturers |
| TRACC Global | Gurugram | CDSCO registration, CE marking, US FDA 510(k) and ISO 13485 | Delhi NCR manufacturers and importers |
| Agile Regulatory | Noida | CDSCO and BIS licensing within a broader business-compliance practice | Importers needing CDSCO plus other Indian compliance approvals |
1. Medfins International
Based in: Chennai (T. Nagar), Coimbatore branch. Focus: CDSCO licences (MD-5, MD-9, MD-15, MD-42), Indian Authorised Agent, ISO 13485, MDSAP, CE marking (EU MDR/IVDR), US FDA 510(k) and registration, Saudi SFDA, UAE, Egypt and ASEAN registrations.
Medfins International has delivered 175+ regulatory projects for 250+ medical device products and 100+ clients. It holds MD-42 wholesale registration premises in Chennai, acts as Indian authorised agent for overseas manufacturers, and publishes free tools such as a CDSCO device classification tool and regulatory checklists. Start with CDSCO registration for medical devices.
2. CliniExperts
Based in: New Delhi. Focus: Regulatory services across drugs, medical devices, IVDs, cosmetics and food, including importer and manufacturer licensing. Often a fit for: Companies with products in several regulated categories.
3. Freyr Solutions
Based in: Global, with an India office in Hyderabad. Focus: Regulatory solutions and operations for pharma, medical devices and consumer health. Often a fit for: Large companies running regulatory work across many countries.
4. Morulaa HealthTech
Based in: Chennai. Focus: Medical device and IVD regulatory consulting, India market access and Indian authorised agent services, global registrations. Often a fit for: Overseas device and IVD makers entering India.
5. Operon Strategist
Based in: Pune. Focus: Medical device product development, turnkey manufacturing facility set-up, regulatory compliance and global registrations. Often a fit for: New manufacturers building a plant as well as getting licences.
6. I3CGLOBAL
Based in: Offices in Bengaluru, Delhi and Kochi. Focus: EU MDR and IVDR CE marking, US FDA 510(k), FDA QMSR and ISO 13485. Often a fit for: EU and US submissions.
7. Maven Profcon Services
Based in: Ahmedabad. Focus: CE marking under EU MDR/IVDR, US FDA 510(k), CDSCO approvals, ISO 13485 and UKCA. Often a fit for: Exporters targeting Europe and the US.
8. Elexes Medical Consulting
Based in: US-headquartered, with an office in Bengaluru. Focus: EU MDR, US FDA submissions, ISO 13485, TGA and UK regulatory work. Often a fit for: Companies focused on US and EU markets.
9. Artixio
Based in: India-based, multi-country network. Focus: Regulatory affairs across many countries, CDSCO medical device services and a regulatory intelligence product. Often a fit for: Multi-country registration programmes.
10. HL Associates
Based in: Ahmedabad. Focus: CDSCO licensing, US FDA, EU MDR, UKCA and ISO 13485. Often a fit for: Gujarat-based manufacturers.
11. TRACC Global
Based in: Gurugram. Focus: CDSCO registration, CE marking, US FDA 510(k) and ISO 13485. Often a fit for: Delhi NCR manufacturers and importers.
12. Agile Regulatory
Based in: Noida. Focus: CDSCO and BIS licensing within a broader business-compliance practice. Often a fit for: Importers needing CDSCO plus other Indian compliance approvals.
Questions to ask before you sign
- Which licence route and risk class do you see for our device, and why?
- Who will prepare our Device Master File and who will answer CDSCO queries?
- How many similar devices have you licensed in the last two years?
- What is included in the fee, and what are the government fees on top?
- What happens after approval: renewals, retention fees, post-approval changes and vigilance?
If you are comparing consultants now, download our free CDSCO, EU MDR and FDA checklists or book a free consultation with Medfins International.