Overview
Medical Device Registration – Overview
What is Medical Device Registration?
Medical Device Registration is the process of obtaining approval from CDSCO for manufacturing, importing, or selling medical devices in India. It ensures that devices meet safety and performance standards and protects patients from substandard or unsafe products.
Who is Eligible for Medical Device Registration?
Manufacturers of medical devices in India
Importers of medical devices for distribution or sale
Indian agents representing foreign manufacturers
Companies dealing in medical equipment, diagnostic devices, surgical instruments, and consumables
Importance and Benefits of Medical Device Registration
Legal authorization to manufacture or sell medical devices in India
Ensures compliance with CDSCO regulations and Medical Devices Rules, 2017
Enhances credibility and trust with hospitals, clinics, and distributors
Avoids penalties, seizures, or business closure
Required for participating in government tenders or contracts
Process of Medical Device Registration
Identify the device classification (Class A, B, C, or D) as per the Medical Devices Rules.
Prepare necessary documents, including device details, manufacturer information, and quality certifications.
Submit the application online on the CDSCO portal.
CDSCO reviews the application and may request inspections or additional documents.
Upon approval, a registration certificate is issued, legally allowing the sale or manufacture of the medical device in India.
Documents Required for Medical Device Registration
Manufacturer/importer PAN and Aadhaar details
Certificate of incorporation/Business registration
Product technical specifications and labeling details
ISO or quality certification (if applicable)
Free Sale Certificate (for imported devices)
Authorization letter (for Indian agent of foreign manufacturer)
Device master file, risk assessment, and clinical evaluation (for Class C/D devices)
How NYAYAPATH LEGAL LLP Can Help You
NYAYAPATH LEGAL LLP provides end-to-end support for Medical Device Registration. We assist in document preparation, classification, online submission, liaising with CDSCO, and follow-ups to ensure timely approval. Our experts make the registration process smooth, compliant, and efficient, enabling manufacturers and importers to launch devices legally in India.
