About Us

About Planwey Medglobal Services Pvt. Ltd.

A specialised regulatory affairs and compliance consulting company dedicated to the medical device and IVD industry in India.

Planwey Medglobal Services Pvt. Ltd. is a specialised regulatory affairs and compliance consulting company 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 provide end-to-end regulatory solutions to help our clients achieve timely approvals and maintain compliance with applicable laws and guidelines.

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Our Mission

To simplify the regulatory approval process for medical device and IVD companies by delivering reliable, efficient, and compliant regulatory consulting services that enable businesses to bring safe and innovative healthcare products to the Indian market.

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Our Vision

To become India's most trusted regulatory affairs partner for the medical device and IVD industry by providing quality-driven, transparent, and customer-focused consulting solutions.

What We Offer

Comprehensive Regulatory Consultancy

  • Medical Device Registration and Licensing
  • IVD Registration and Licensing
  • Preparation and Compilation of Regulatory Dossiers
  • Online Application Submission through CDSCO Portal
  • Import License Applications
  • Manufacturing License Applications
  • Regulatory Documentation Review
  • Compliance and Regulatory Support
  • Post-Approval Regulatory Assistance
  • Guidance on Medical Device Rules (MDR), 2017
Why Choose Us

A Partner You Can Rely On

  • Specialized expertise in Medical Device and IVD regulations
  • End-to-end regulatory support from documentation to approval
  • Timely and accurate dossier preparation
  • Professional handling of CDSCO online submissions
  • PAN India service coverage
  • Dedicated client support and regulatory guidance

Our Commitment

Planwey Medglobal Services Pvt. Ltd. is committed to helping organizations navigate complex regulatory requirements with confidence โ€” ensuring smooth approvals and long-term compliance across the Indian healthcare sector.

Regulatory Excellence. Compliance Assured. Market Access Simplified.

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.