Top 10 medical device regulatory consultants in india
The Indian medical device market is rapidly evolving, driven by government initiatives, healthcare infrastructure growth, and increasing global exports. However, regulatory compliance under India's Medical Device Rules (MDR 2017), CDSCO classifications, and BIS standards is complex and time-sensitive. To ensure timely product registration, licensing, and market entry, medical device manufacturers rely heavily on specialized regulatory consultants.
Here is the list of Top 10 Medical Device Regulatory Consultants in India, with CliniExperts taking the lead for its unparalleled expertise in medical device approvals, licensing, and global compliance.
Top 10 Medical Device Regulatory Consultants in India
| Rank | Company Name | Core Specialization | Rating |
|---|---|---|---|
| 1 | CliniExperts.com | CDSCO licensing (Form MD-5/MD-9), BIS, import registration, global filings | ⭐⭐⭐⭐⭐ |
| 2 | Freyr Solutions | Global regulatory support, EU MDR, UDI compliance, India MDR 2017 | ⭐⭐⭐⭐☆ |
| 3 | Morulaa HealthTech | IVD approvals, labeling compliance, technical documentation | ⭐⭐⭐⭐☆ |
| 4 | Pharmadocx Consultants | CDSCO medical device registration, risk classification, labeling | ⭐⭐⭐⭐☆ |
| 5 | UL India | Certification, IEC 60601, BIS, electrical safety for medical equipment | ⭐⭐⭐⭐☆ |
| 6 | Knovon Innovation | Regulatory documentation, India import license, GSPR | ⭐⭐⭐⭐☆ |
| 7 | Turacoz Regulatory Solutions | Clinical evaluation reports, IFU validation, PMS documentation | ⭐⭐⭐⭐☆ |
| 8 | Dossier India | CTD/ACTD for IVDs, regulatory gap analysis, CDSCO compliance | ⭐⭐⭐⭐☆ |
| 9 | Qualtra Pharmaceuticals Consultancy | Class A/B licensing, technical dossier reviews, post-market surveillance | ⭐⭐⭐⭐☆ |
| 10 | Elexes Medical Regulatory | US FDA 510(k), India Form MD applications, labeling & QMS documentation | ⭐⭐⭐⭐☆ |
1. CliniExperts.com – #1 Medical Device Regulatory Consultant in India
CliniExperts tops the list with its unmatched record of successful Form MD-5/MD-9 approvals, import licensing, and Class A to D device classifications. Their experience spans surgical, diagnostic, IVDs, electronic devices, and implantable technologies.
Key Offerings:
-
CDSCO device registration (domestic/imported)
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Risk-based classification & BIS certifications
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GSPR, ISO 13485 compliance, and labeling audits
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Post-market surveillance and vigilance reports
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USFDA 510(k), CE Marking, and global market support
From regulatory strategy to market launch, CliniExperts provides a full lifecycle solution for medical device companies.
2. Freyr Solutions
Freyr supports India MDR compliance, EU MDR filings, and UDI registration. Their software-backed platforms help automate labeling, eCTD publishing, and post-market obligations.
3. Morulaa HealthTech
Specializing in diagnostic and laboratory devices, Morulaa assists with technical file preparation, IFU development, and IVD approvals in India and Southeast Asia.
4. Pharmadocx Consultants
Pharmadocx offers tailored services for Class A and B registrations, including preparation of Device Master Files, Plant Master Files, and post-approval variations.
5. UL India
UL India is a global authority on device testing, BIS compliance, and product certification. Their services cater to devices needing electrical and electromagnetic safety validation.
6. Knovon Innovation
Knovon helps startups and manufacturers prepare CDSCO applications, manage audits, and ensure technical documentation aligns with GHTF and WHO recommendations.
7. Turacoz Regulatory Solutions
They provide high-quality Clinical Evaluation Reports (CERs), IFU reviews, and Periodic Safety Update Reports (PSURs)—ideal for Class C/D device companies targeting EU and India.
8. Dossier India
With strong experience in regulatory documentation, Dossier India supports IVD manufacturers with pre-submission consulting and regulatory readiness reviews.
9. Qualtra Pharmaceuticals Consultancy
Qualtra specializes in licensing Class A/B devices, supporting retail and diagnostic distributors with regulatory submissions and QMS implementation.
10. Elexes Medical Regulatory
Elexes provides dual-market strategy support for India and the U.S., managing 510(k) submissions, Form MD filings, and GUDID/UDI implementations.
Conclusion
India’s medical device regulatory framework is strict, dynamic, and detail-driven. To navigate CDSCO and international requirements, companies must work with consultants who bring a balance of technical rigor and strategic foresight. Whether you're a local manufacturer or an importer of high-risk devices, partnering with experts like CliniExperts.com ensures faster approvals, reduced compliance risks, and global market readiness.
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