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Medical Device Registration
Complete registration and licensing under the Medical Device Rules, 2017 — from assessment to approval.
CDSCO Regulatory Affairs · India
Your Trusted Regulatory Affairs Partner for Medical Devices & IVDs in India
End-to-end regulatory and compliance solutions that help Medical Device and IVD companies achieve timely CDSCO approvals and seamless market access across India.
- 📜 CDSCO Expertise
- 🔒 Confidentiality Assured
- 🌍 PAN India Coverage
🔒 Confidentiality & Data Protection 📜 CDSCO Regulatory Expertise ⚡ Timely Project Execution 🤝 Dedicated Client Support 📈 Compliance-Focused Approach
About Planwey Medglobal
Specialist Regulatory Consulting for India's Healthcare Industry
Planwey Medglobal Services Pvt. Ltd. is a specialised regulatory affairs and compliance consulting firm dedicated to supporting Medical Device and In Vitro Diagnostic (IVD) manufacturers, importers, and distributors across India.
With extensive knowledge of Indian medical device regulations and the requirements of the Central Drugs Standard Control Organization (CDSCO), we deliver end-to-end regulatory solutions that help clients achieve timely approvals and maintain ongoing compliance.
More About UsCDSCORegulatory specialists
MDR 2017Rules-aligned guidance
End-to-EndDocumentation to approval
PAN IndiaService coverage
Our Services
Comprehensive Regulatory & Compliance Solutions
We assist manufacturers, importers, authorized agents and healthcare organisations in meeting CDSCO requirements efficiently and effectively.
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IVD Registration & Licensing
Regulatory approvals for In Vitro Diagnostic products in full compliance with CDSCO requirements.
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Import License Applications
CDSCO import licenses for foreign manufacturers and their authorized Indian representatives.
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Manufacturing License
Licensing support for domestic manufacturers of medical devices and IVD products in India.
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Dossier Preparation
Comprehensive technical documentation — device descriptions, risk classification, performance data and more.
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CDSCO Portal Management
End-to-end online application handling — submission, uploads, query responses and tracking.
Why Choose Us
Why Leading Healthcare Companies Trust Planwey Medglobal
A regulatory partner built on expertise, confidentiality and dependable delivery.
Industry Expertise
Deep, specialised knowledge of Medical Device and IVD regulations in India.
CDSCO Regulatory Specialists
Focused expertise in CDSCO pathways, classifications and submission requirements.
PAN India Support
Consistent regulatory support for clients across every region of India.
Timely Project Execution
Disciplined timelines and proactive follow-up to keep approvals on track.
Strict Confidentiality
Professional, confidential handling of all client information and documentation.
Dedicated Professionals
A committed team of regulatory professionals guiding you at every step.
Industries We Serve
Partnering Across the Medical Device & IVD Ecosystem
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Medical Device Manufacturers
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IVD Manufacturers
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Importers
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Authorized Indian Agents
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Healthcare Technology Companies
Get Started
Ready to Bring Your Product to the Indian Market?
Our regulatory experts are ready to support your Medical Device and IVD approval journey across India.