Service Details

Medical Device Registration Services 👇

🏥 What is Medical Device Registration?

The Medical Device Registration process is a regulatory requirement under the Drugs and Cosmetics Act, 1940, and the Medical Device Rules, 2017, governed by the Central Drugs Standard Control Organisation (CDSCO), India’s national regulatory authority.

It ensures that medical devices are safe, effective, and meet quality standards before being manufactured, imported, or sold in India.

✅ Who Needs CDSCO Medical Device Registration?

Manufacturers of medical devices in India
Importers of foreign-made medical devices
Authorized Indian Agents representing foreign manufacturers
Distributors dealing in regulated medical devices

⚕️ Categories of Medical Devices (as per CDSCO Classification)

Class	Risk Level	Examples
Class A	Low Risk	Surgical dressings, thermometers
Class B	Low–Moderate Risk	Needles, suction equipment
Class C	Moderate–High Risk	X-ray machines, infusion pumps
Class D	High Risk	Pacemakers, heart valves

🧾 Documents Required for Medical Device Registration

1. Business Documents

PAN Card & GST Registration
Certificate of Incorporation / Factory License
Authorized Signatory ID Proof
ISO 13485 Certificate

2. Technical Documents

Device Master File (DMF)
Plant Master File (PMF)
Product Description, Intended Use & Shelf Life
Test Reports / Quality Certificates

3. Regulatory Documents

Free Sale Certificate (for importers)
CE / USFDA / ISO Certificates (if available)
Undertaking of compliance with MDR, 2017
Labeling samples as per CDSCO norms

📝 Step-by-Step Medical Device Registration Process

Determine Classification – Identify Class A, B, C, or D device
Appoint Authorized Indian Agent (for foreign manufacturer)
Prepare Documentation – DMF, PMF, ISO, and quality compliance
Apply Online on CDSCO SUGAM Portal (https://cdsco.gov.in)
Review by CDSCO – Application examination and clarification (if any)
Grant of Registration Certificate – Issued with a unique device registration number

🏢 Post-Registration Compliances

Maintain proper quality systems and records
Submit periodic reports to CDSCO
Renew license before expiry
Report any adverse events related to the device

💼 Our Medical Device Registration Services Include:

Classification & eligibility assessment
Preparation of technical and regulatory documentation
CDSCO SUGAM portal filing and fee payment
Coordination with CDSCO and State Licensing Authorities
Post-registration compliance and renewal support

⏳ Timeline & Cost

🕒 Timeline: 30–90 working days (depending on class & review time)
💰 Government Fees: ₹1,000 – ₹50,000 (based on class and application type)
🧾 Professional Fees: Based on device type and documentation complexity

📞 Contact for Assistance

SAI KUMAR VARALA & CO
✅ Medical Device Registration | CDSCO Compliance | ISO 13485 | Import / Manufacturing License | Post-Approval Support
📱 Mobile: 7337500748
📧 Email: saivarala33@gmail.com