Medical Device Registration in India — CDSCO Class A to D Compliance
Under India’s Medical Devices Rules (MDR), 2017, all medical devices are classified into four risk-based categories: Class A (Lowest risk), Class B (Low-moderate risk), Class C (Moderate-high risk), and Class D (Highest risk). Whether you are a domestic manufacturer seeking Form MD-3/MD-5/MD-7/MD-9 licenses or an importer applying for MD-14/MD-15 registrations, non-compliance leads to customs detention and market ban. DK Reg Compliance manages ISO 13485 alignment, Device Master Files, Class A NSNM self-notifications, and full SUGAM portal filings.
- Domestic manufacturers of Class A and B medical devices applying to State Licensing Authorities
- Domestic manufacturers of Class C and D high-risk devices applying to CDSCO Central Authority
- Importers and foreign brand owners bringing medical equipment and instruments into Indian hospitals
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Overview & Local Scope
Fast-Track Medical Device Registration India | CDSCO Class A–D Consultant in Faridabad
Under India’s Medical Devices Rules (MDR), 2017, all medical devices are classified into four risk-based categories: Class A (Lowest risk), Class B (Low-moderate risk), Class C (Moderate-high risk), and Class D (Highest risk). Whether you are a domestic manufacturer seeking Form MD-3/MD-5/MD-7/MD-9 licenses or an importer applying for MD-14/MD-15 registrations, non-compliance leads to customs detention and market ban. DK Reg Compliance manages ISO 13485 alignment, Device Master Files, Class A NSNM self-notifications, and full SUGAM portal filings.
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Contact UsDomestic manufacturers of Class A and B medical devices applying to State Licensing Authorities
Domestic manufacturers of Class C and D high-risk devices applying to CDSCO Central Authority
Importers and foreign brand owners bringing medical equipment and instruments into Indian hospitals
In-vitro diagnostic (IVD) reagent and analyzer manufacturers/importers across Class A to D
Startups and medtech companies introducing innovative or AI-powered medical software/devices
Step-by-step process
How our Faridabad registration works
Risk Classification Assessment: We verify whether your device falls under Class A (NSNM self-notification vs measuring/sterile), Class B, C, or D per CDSCO predicate rules.
Technical Dossier Assembly (DMF/PMF): We prepare comprehensive Device Master Files including essential principles checklist, risk management (ISO 14971), and design verification.
Quality System Alignment: We verify ISO 13485:2016 quality manual consistency with Indian Medical Devices Rules, 2017.
SUGAM Application Filing: We submit Form MD-3/MD-5 (Domestic) or Form MD-14 (Import) with appropriate fee challans on the SUGAM portal.
Audit Defense & License Grant: We coordinate state SLA or notified body audits for Class A/B and CDSCO central audits for Class C/D until MD-5/MD-9/MD-15 issuance.
Documents required
Filing checklist for Faridabad
- Device Master File (DMF) covering executive summary, intended use, drawings, and raw materials
- Plant Master File (PMF) describing manufacturing site cleanroom class, sterilization, and equipment
- ISO 13485:2016 Quality Management System certificate issued by an accredited certification body
- Risk Management Report prepared in accordance with ISO 14971 standards
- Clinical Evaluation Report (CER) / Published safety and performance literature summaries
- Biocompatibility test reports (ISO 10993) for patient-contacting medical devices
- Free Sale Certificate (FSC) from country of origin (for imported medical devices)
Verified Support in Faridabad
Whether you are located in the business center of Faridabad or surrounding industrial corridors, our consultants manage state and zonal submissions directly.
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