Medical device regulatory consultants in India

 The medical device industry in India is rapidly expanding, with increasing emphasis on safety, efficacy, and regulatory compliance. For manufacturers and importers, partnering with the right Medical device regulatory consultants in India is essential to navigate complex regulatory frameworks, obtain approvals, and maintain compliance with both national and international standards. Below is a list of the top consulting firms providing specialised medical device regulatory services in India.

1. CliniExperts

CliniExperts stands out as the leading medical device regulatory consultant in India. With a strong team of regulatory professionals, scientific experts, and compliance specialists, CliniExperts provides end-to-end support from device classification and documentation to CDSCO registration and post-market surveillance. They also assist global manufacturers with CE marking, US FDA submissions, and regulatory alignment for EU, UK, and US markets.

2. Freyr Solutions

Freyr Solutions offers comprehensive regulatory support for medical devices and in-vitro diagnostics (IVDs). Their services include regulatory strategy, dossier preparation, labelling compliance, and country-specific submissions for India and major global markets.

3. ELC Group

ELC Group provides global regulatory affairs consulting, including device registration, technical documentation, and regulatory intelligence. They are well-known for assisting companies in entering regulated markets through streamlined compliance strategies.

4. Vardhaman LifeCare

Vardhaman LifeCare focuses on regulatory consulting for medical devices and pharmaceuticals. Their services include CDSCO registration, import licensing, and documentation management, with strong expertise in Class B, C, and D device approvals.

5. RegDevice India

RegDevice India is a specialised consulting firm offering end-to-end medical device regulatory solutions. They support clients with device categorisation, risk analysis, dossier compilation, and clinical evaluation report preparation.

6. Maven Regulatory Affairs

Maven Regulatory Affairs assists companies in obtaining CDSCO and ISO certifications for medical devices. Their consulting covers product classification, technical file preparation, and guidance on compliance with global medical device regulations.

7. Morulaa HealthTech

Morulaa HealthTech provides technical and regulatory consulting for medical devices and diagnostic equipment. They assist with import registration, licensing, and conformity assessment for Indian and international clients.

8. Pharmazone Consulting

Pharmazone Consulting offers regulatory affairs and clinical research services with a focus on device and drug-device combination products. They have experience managing documentation, submissions, and quality-compliance audits.

9. ClinChoice

ClinChoice provides regulatory and clinical services to medical device companies seeking approvals across multiple geographies. Their expertise includes post-market surveillance, vigilance, and technical documentation.

10. Qserve Group

Qserve Group is a global regulatory consulting firm with a presence in India. They offer MDR, IVDR, and ISO certification support, along with clinical evaluation, post-market monitoring, and EU representation for device manufacturers.

Conclusion

The growing demand for safe and effective medical devices in India has made regulatory compliance a critical business function. Partnering with experienced medical device regulatory consultants in India such as CliniExperts can simplify complex procedures, accelerate market entry, and ensure long-term compliance with evolving national and international standards.

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