Medical Device Registration

Medical Device Registration in India

Ensure smooth Medical Device Registration online in India with expert guidance from Tax Pal Solutions. We provide full compliance support under CDSCO regulations to help you bring your device to market quickly and legally.

What is Medical Device Registration?

Medical Device Registration in India is the official approval granted by the Central Drugs Standard Control Organization (CDSCO), allowing the manufacture, import, and sale of medical devices. Registration ensures:

• Legal market access
• Safety and quality compliance
• Trust among healthcare providers and patients

Without registration, selling or manufacturing medical devices is illegal in India.

Why Registration is Mandatory?

Medical device registration is mandatory because it:

• Protects patients from unsafe devices
• Ensures compliance with Indian and global standards
• Avoids legal penalties
• Builds credibility and trust among hospitals, doctors, and patients
• Unlocks government contracts and tender opportunities
• Enables traceability and post-market surveillance

Medical Device Classification in India

• Class A & B → State Licensing Authority (SLA)
• Class C & D → Central Licensing Authority (CLA/CDSCO)

Who Can Apply?

Eligible Entities:

• Domestic Manufacturers – Indian companies producing devices locally
• Importers – Indian entities importing devices
• Foreign Manufacturers – Via an Indian Authorized Agent (IAA) or Indian subsidiary

Benefits of Medical Device Registration

• Legal Market Access – Sell devices in India lawfully
• Credibility & Trust – Gain confidence of doctors, hospitals, and patients
• Commercial Opportunities – Government tenders, hospital contracts, eMarketplace (GeM)
• Patient Safety – Ensures devices meet safety and performance standards
• Global Pathway – Facilitates exports and aligns with international standards

Process for Indian Manufacturers

1. Classify Device – Determine risk class (A, B, C, D)
2. Quality Management System – ISO 13485 compliance required
3. Prepare Documents – PMF, DMF, undertakings, stability data
4. Apply to Authority – SLA for Class A/B, CLA (CDSCO) for Class C/D
5. Submit Application on SUGAM Portal – Use Form MD-3 (A/B) or MD-7 (C/D)
6. Inspection & Audit – CDSCO or State Authority inspection
7. Receive License – Form MD-5 (A/B) or MD-9 (C/D)

Process for Importers (Foreign Manufacturers)

1. Appoint Indian Authorized Agent (IAA)
2. Prepare Technical Dossier – DMF, PMF, ISO 13485, CE/FSC, Power of Attorney
3. Submit Form MD-14 on SUGAM Portal
4. Respond to CDSCO Queries – Technical presentations if required
5. Receive Import License (Form MD-15)

Documents Required

For Domestic Manufacturers:

• Form MD-3 / MD-7
• PMF & DMF
• ISO 13485 certificate
• Manufacturing details & quality system documents
• Clinical evaluation & performance data
• Labeling & packaging info
• Fee payment receipt

For Importers:

• Form MD-14
• PMF & DMF
• ISO 13485 certificate
• CE Certificate / Declaration of Conformity
• Free Sale Certificate (FSC)
• Power of Attorney
• Post-market surveillance plan
• Fee payment receipt

Fee Structure in India

• Foreign Importer fees are slightly higher
• License retention fees apply annually
• Additional costs may include audits, testing, and consultancy

Timeline for Registration

• Class A & B → 3 to 6 months
• Class C & D → 6 to 12 months

Tip: Complete documentation and prompt responses to queries ensure faster approvals.

Making Changes After Registration

• Major Changes – Affect device safety/design → Fresh approval needed
• Minor Changes – Do not affect performance → Prior approval required
• Administrative Changes – Labeling, company info → Inform CDSCO

Labelling Requirements

Medical device labels in India must include:

• Device name & model
• Manufacturer & importer details
• Batch/lot number
• Manufacturing & expiry dates
• Usage instructions & precautions
• Regulatory marks & license number