Medical Devices Registration in India: Process, Fees and Approval

• Medical Devices Registration in India is governed by CDSCO under the Medical Device Rules, 2017.
• Every manufacturer or importer must secure a Medical Device License before marketing or distributing devices in India.
• Compliance involves classification, QMS audits, documentation, regulatory filings, and continuous post-market surveillance.
• Registration supports transparent operations, traceability, and long-term business growth for Medical Device Manufacturers.
• Valid CDSCO registration is essential for hospital sales, distributor acceptance, tenders, and institutional procurement.

Introduction

In early 2024, a Delhi-based orthopaedic manufacturer approached our consulting team with a worrying situation. Their distributors were demanding the CDSCO Medical Device License before placing orders, but the manufacturer was unsure whether their device even required registration. Their internal team had conflicting interpretations of the Medical Device Rules.

Meanwhile, compliance deadlines were approaching and the business was losing opportunities every day.

That case is not unique. Across India, both large and small Medical Device Manufacturers face the same question:

“How do we correctly navigate the Medical Devices Registration process under CDSCO and ensure full compliance without delays?”

This guide is written exactly for those decision-makers — manufacturers, startups, importers, and healthcare suppliers needing a clear, authoritative, consultant-level breakdown of the entire regulatory framework.

What is Medical Devices Registration in India?

The Central Drugs Standard Control Organisation (CDSCO) regulates all Medical Devices in India under the Medical Device Rules (MDR), 2017. Registration is mandatory for any device notified under these rules before it can be sold, marketed, manufactured, or imported

At its core, the purpose of Medical Devices Registration is straightforward: To ensure that every Medical Device in India is safe, effective, and manufactured under a robust quality control system.

Through this registration, manufacturers and importers must:

• Classify their device into Class A, B, C, or D based on risk.
• Submit technical documentation such as the Device Master File (DMF) and Plant Master File (PMF).
• Demonstrate compliance with ISO 13485 and relevant safety standards.
• Undergo facility inspection and quality audits (for higher-risk devices).
• Obtain a valid license via the CDSCO SUGAM portal (MD-5, MD-9, or MD-15).

This process protects patients, supports regulatory accountability, and ensures that only safe and reliable devices reach hospitals and healthcare providers.

Why Medical Devices Registration Matters for Manufacturers?

Manufacturers often underestimate the importance of a compliant Medical Device License. But CDSCO has tightened enforcement significantly over the last five years.

Common business risks due to non-compliance:

• Inability to participate in government tenders
• Penalties under Drugs & Cosmetics Act
• Seizure of non-licensed stock
• Restrictions by distributors and hospitals
• Legal liability in case of device failure

On the commercial side, distributors now insist on a valid CDSCO Registration number because healthcare facilities increasingly verify regulatory credentials before procurement.

In other words, compliance is no longer optional — it is a market access prerequisite.

Classification of Medical Devices in India

The foundation of every Medical Device Process begins with correct classification. CDSCO follows a risk-based framework similar to international regulations.

Categories

Why classification matters

• It determines the type of Medical Device License required.
• It affects timelines, documentation, and audit requirements.
• It determines whether CDSCO or State Licensing Authority will issue the license.

Many delays during CDSCO Registration originate from incorrect classification. Manufacturers frequently misjudge their device risk level or incorrectly refer to foreign classification systems.

Regulatory Pathways for Medical Devices Registration

CDSCO provides different licensing categories depending on whether the business is a manufacturer, importer, or trader.

Quality Management System Requirements

A core mandate for Medical Device Manufacturers is maintaining a QMS equivalent to ISO 13485.

However, most clients initially misunderstand this requirement.

A common scenario: A manufacturer believes that having ISO 13485:2016 automatically guarantees regulatory approval. In reality, CDSCO evaluates:

• Plant layout
• Sterilization validation
• Calibration and traceability protocols
• Raw material control
• Complaint handling
• CAPA procedures
• Production batch records

During audits, inspectors frequently reject applications solely because ISO documentation was not aligned with MDR 2017 requirements.

In short, ISO certification is not enough — QMS must match CDSCO’s regulatory expectations.

Key Benefits of Medical Device Registration

Requirements for Medical Device Registration in India

• Device Classification & Notification: Confirm the device is listed under CDSCO’s notified categories (A, B, C, or D).
• Quality Management System (QMS): Valid ISO 13485:2016 certification and evidence of alignment with the Fifth Schedule of MDR 2017.
• Technical Documentation: Comprehensive Device Master File (DMF), Plant Master File (PMF), Risk Management File (ISO 14971), and Clinical Evaluation Report (CER - for higher classes).
• Regulatory Certificates (For Imports): Valid Free Sale Certificate (FSC) or Market Authorization from the home country.
• Site Inspection & Audit Readiness: For Class B, C, and D, the site must be ready for inspection by the Licensing Authority to verify compliance with QMS/GMP.

Documentation Required for Medical Devices Registration

The Medical Device Process under CDSCO is documentation-heavy. Manufacturers must provide complete technical and administrative files including:

Technical Documents

• Device master file
• Design dossier
• Performance evaluation
• Clinical evaluation report (CER)
• Sterilization validation (if applicable)
• Risk management file as per ISO 14971
• Biocompatibility data

Administrative Documents

• Constitution details
• Manufacturing plant details
• QMS certificates
• Undertakings and declarations
• Labels, IFU, packaging material
• Free sale certificate for imported devices

Accuracy matters because any inconsistency leads to screening failures or outright rejection.

Step-by-Step Process for CDSCO Medical Device Registration

Below is the consultant-level explanation that manufacturers often seek.

Step 1: Device Classification & Notification Check

• The team first verifies whether the device is listed under the latest notified list published by CDSCO. The classification determines the Licensing Authority and required documentation.

Step 2: Gap Assessment & QMS Alignment

• A compliance specialist audits the manufacturer’s QMS, documents, and facility conditions against MDR 2017 requirements. This identifies gaps (e.g., missing validation data or outdated SOPs).

Step 3: Technical File Preparation

• Compile the Device Master File (DMF), Plant Master File (PMF), Risk Management File (RMF), and all biological/performance data.

Step 4: Online Portal Registration

• Manufacturers create a profile under the CDSCO SUGAM portal. All subsequent filings, license applications, and responses are submitted through this system.

Step 5: Application Filing

• Submit the application (e.g., MD-3 for manufacturing, MD-14 for import) to the relevant authority (SLA for A/B, CDSCO HQ for C/D).

Step 6:Audit / Inspection

• For Class B, C, and D devices, CDSCO or SLA officials inspect the manufacturing site to verify compliance with QMS/GMP.

Step 7:License Issuance

• Once approved, CDSCO issues the license (MD-5, MD-9, or MD-15). The license number must appear on labels and packaging.

Step 8:Post-Market Surveillance (PMS)

• Manufacturers must maintain continuous vigilance reporting, adverse event records, and batch traceability as per the rules.

Medical Device Registration – Timeline, Cost, Validity & Renewal

Why Silvereye Certifications Is the Best Consultant for Medical Device Registration

• Expert Knowledge of CDSCO & MDR 2017

Silvereye Certifications has strong regulatory expertise, covering classification, documentation, and licensing requirements for all medical device categories.

• High-Quality Technical Documentation

The team prepares DMF, PMF, CER, RMF, and QMS documents in the exact formats expected by CDSCO, reducing queries and speeding approvals.

• End-to-End Registration Support

From device classification to SUGAM filing, inspection preparation, and post-market guidance, Silvereye manages the entire registration cycle.

• Practical, Manufacturing-Focused Approach

Consultants understand real factory conditions and help manufacturers align processes with ISO 13485 and MDR requirements in a practical, cost-effective way.

• Strong Track Record & Faster Approvals

Accurate documentation, correct classification, and structured submissions help clients achieve approvals with minimal delays.

• Trusted by Manufacturers & Importers

Silvereye supports both Indian manufacturers and global companies entering the Indian market, ensuring smooth licensing and compliance.

Silvereye Certifications is a trusted compliance partner for Medical Device Registration in India, known for its strong expertise in CDSCO regulations and MDR 2017 requirements. The team prepares high-quality technical documentation, manages complete licensing workflows on the SUGAM portal, and ensures manufacturers meet ISO 13485 and risk-management standards.

With practical understanding of factory operations and a proven record of fast, accurate approvals across all device classes, Silvereye offers reliable, end-to-end support for both Indian manufacturers and global importers entering the Indian market.

Conclusion

Manufacturers planning to enter or expand in the Indian healthcare industry must treat Medical Devices Registration as a strategic investment rather than a regulatory formality. A valid CDSCO Registration ensures market access, distributor confidence, legal protection, and alignment with global quality expectations. The best outcomes always come when manufacturers approach the registration with a structured plan: correct classification, robust documentation, audit readiness, and continuous compliance.

If you require expert support in completing your Medical Device License or navigating the Medical Device Process, Silvereye Certifications provides end-to-end guidance backed by deep regulatory expertise and a strong track record of successful approvals. With the right consultant, the compliance journey becomes faster, predictable, and fully aligned with CDSCO requirements.

Ready to secure your Medical Device License and ensure compliance?