What is Medical Device Registration?
In India, the manufacturing, import, sale, and distribution of medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017 (MDR 2017). Registration is a mandatory legal requirement to ensure that devices meet safety, quality, and performance standards before they reach patients.
The entire application process is managed online through the SUGAM portal, ensuring transparency and efficiency.
Classification of Medical Devices
Medical devices are classified into four risk-based categories. This classification determines the regulatory pathway and the fees involved:
- Class A (Low Risk): Examples include thermometers, surgical dressings, and tongue depressors. Regulated by State Licensing Authorities (SLA).
- Class B (Low-Moderate Risk): Examples include hypodermic needles and infusion sets. Regulated by State Licensing Authorities (SLA).
- Class C (Moderate-High Risk): Examples include lung ventilators and bone fixation plates. Regulated by Central Licensing Authority (CLA/CDSCO).
- Class D (High Risk): Examples include heart valves and pacemakers. Regulated by Central Licensing Authority (CLA/CDSCO).
Who Can Apply?
- Domestic Manufacturers: Indian companies manufacturing devices locally.
- Importers: Indian entities importing devices from abroad.
- Foreign Manufacturers: Cannot apply directly. They must appoint an Indian Authorized Agent (IAA) who holds a valid wholesale license (Form 20B/21B) to apply on their behalf.
Benefits of Registration
- Legal Compliance: Avoid penalties, confiscation, and legal action for selling unregistered devices.
- Market Access: Legally sell to hospitals, clinics, and pharmacies across India.
- Government Tenders: Mandatory for participating in procurement by AIIMS, Army hospitals, and other government bodies.
- Consumer Trust: Demonstrates that your product meets stringent safety and quality standards.
- Global Recognition: CDSCO approval is increasingly recognized in other emerging markets.
Registration Process
For Foreign Manufacturers (Import License)
- Appoint an IAA: Designate an Indian Authorized Agent with a valid license.
- Prepare Dossiers: Compile the Device Master File (DMF) and Plant Master File (PMF).
- Submit Application: The IAA submits the application (Form MD-14) on the SUGAM portal.
- Review & Query: CDSCO reviews the application and may raise technical queries.
- Grant of License: Upon approval, the Import License (Form MD-15) is issued.
For Domestic Manufacturers
- QMS Implementation: Ensure the facility complies with ISO 13485 and MDR 2017 standards.
- Submit Application: Apply via SUGAM (Form MD-3 for Class A/B, Form MD-7 for Class C/D).
- Audit: The Notified Body or CDSCO officials will inspect the manufacturing facility.
- Grant of License: Upon successful audit, the Manufacturing License (Form MD-5 for Class A/B, Form MD-9 for Class C/D) is issued.
Documents Required
The documentation is extensive and includes:
- Device Master File (DMF): Detailed technical info on design, materials, testing, and risk analysis.
- Plant Master File (PMF): Details of the manufacturing facility, personnel, and quality control.
- ISO 13485 Certificate: Proof of a compliant Quality Management System.
- Power of Attorney: Legal authorization for the Indian Agent (for importers).
- Free Sale Certificate (FSC): Proof the device is sold in the country of origin (for importers).
- CE/FDA Certificate: Approvals from other regulatory bodies (if available).
- Labels & IFU: Product labels and Instructions for Use.
Fees & Validity
Fees: Fees are charged per manufacturing site and per distinct medical device. They vary significantly by class (e.g., $1,000 for Class A site vs $3,000 for Class D site for importers).
Validity: Licenses are valid in perpetuity, provided a retention fee is paid every 5 years. Failure to pay the retention fee can lead to license cancellation.
