Medical Device Import and Manufacturing Services (CDSCO)

🏛️ Regulatory Overview

In India, the regulation of medical devices is governed by the Ministry of Health and Family Welfare, through the Central Drugs Standard Control Organization (CDSCO) under the provisions of the Medical Devices Rules, 2017.

Licenses for import and manufacturing of medical devices are issued by the following authorities based on the device class:

🔹 Import Licenses

All classes of medical devices—Class A, B, C, and D—are regulated centrally.
➡️ Import licenses are issued by the Central Licensing Authority (CLA) under CDSCO.

🔹 Manufacturing Licenses

Issuance of manufacturing licenses depends on the classification of the medical device:

This tiered approach ensures that lower-risk devices are handled at the state level for faster approvals, while higher-risk devices undergo more detailed scrutiny at the central level.

Our team at IKargos works closely with both State and Central authorities to ensure smooth, compliant processing of your license applications.

Medical Device Import and Manufacturing Services

At IKargos, we specialize in providing comprehensive services for medical device importation and manufacturing, ensuring compliance with all regulatory frameworks and quality standards. Whether you are an overseas manufacturer entering a new market or a domestic player looking to expand operations, we support you throughout the regulatory and operational journey.

✅ Scope of Services

1. Medical Device Import Services

We help companies legally import medical devices into India, in full compliance with national regulatory bodies such as CDSCO (Central Drugs Standard Control Organization).

Key Services:

• Regulatory strategy and risk classification
• Import license application (e.g., Form MD-14 / MD-15)
• Coordination with authorized Indian agents
• Customs clearance support
• Labelling and packaging validation
• Post-market surveillance & adverse event reporting

2. Medical Device Manufacturing Services

From facility licensing to production and quality assurance, we support full-cycle medical device manufacturing under applicable rules like the Medical Devices Rules, 2017 (India) or equivalent jurisdictional laws.

Key Services:

• Manufacturing license (Form MD-5 / MD-9)
• Facility layout, validation & GMP compliance
• Device classification and documentation
• ISO 13485 QMS setup & audit support
• Clinical evaluation and safety data generation
• Sterilization and packaging compliance

Securing a CDSCO import license for medical devices provides several advantages:

1. Assurance of compliance with applicable laws and regulations.
2. Guarantees product safety and quality.
3. Expands market opportunities.
4. Enhances consumer protection by upholding quality standards.

Licenses for import and manufacturing of medical devices are issued by the following authorities based on the device class:

🔹 Import Licenses

All classes of medical devices—Class A, B, C, and D—are regulated centrally.
➡️ Import licenses are issued by the Central Licensing Authority (CLA) under CDSCO.

🔹 Manufacturing Licenses

Issuance of manufacturing licenses depends on the classification of the medical device:

This tiered approach ensures that lower-risk devices are handled at the state level for faster approvals, while higher-risk devices undergo more detailed scrutiny at the central level.

Our team at IKargos works closely with both State and Central authorities to ensure smooth, compliant processing of your license applications.

🗂️ Documentation Required

Depending on the device class (A, B, C, or D) and service (import or manufacture), the following documents are typically required:

📦 For Importers (Form MD-14/15):

• Power of Attorney / Letter of Authorization
• Free Sale Certificate from country of origin
• ISO 13485 certificate of manufacturer
• CE/FDA/TGA approval copies (if applicable)
• Plant Master File (PMF)
• Undertaking for post-market surveillance
• Device labels and IFU (Instructions for Use)

🏭 For Manufacturers (Form MD-5/MD-9):

• Site Master File / Facility layout
• Quality Manual (ISO 13485:2016)
• Risk Management File (ISO 14971)
• Device design and product specifications
• SOPs for sterilization, validation & recalls
• Equipment calibration logs
• Bio-compatibility and clinical safety data
• Audit records & internal training logs

⏱️ Timelines for Approval

Here’s an overview of estimated timelines for approval under normal conditions:

⚠️ Note: Timelines may vary based on device class, completeness of documents, and regulatory workload.

💰 Government Fees

Fees are prescribed by CDSCO (or relevant authority) based on device class and type of application.

📦 Import License (per application):

• Class A Medical Devices: $1,000 per site and Per device $ 50.
• Class B Medical Devices: $2,000 per site and Per device $ 1000.
• Class C and D Medical Devices: $3,000 per site and Per device $ 1500.
• Class A or Class B in vitro diagnostic: $ 1000 Per site and per device $ 10
• Class C or Class D in vitro diagnostic: $ 3000 Per site and per device $ 500

🏭 Manufacturing License:

• Class A/B (per site): ₹5,000 and Per Product ₹500.
• Class C/D (per site): ₹50,000 and Per product ₹1000.

💡 Fees are subject to periodic revisions by the government. We will guide you with the latest official fee structure.

📋 Our End-to-End Process

1. Consultation & Classification
   We begin by evaluating your product and identifying its regulatory classification.
2. Documentation Preparation
   We help you compile, review, and submit all mandatory files.
3. Application Submission
   Applications are filed online through the CDSCO SUGAM portal or equivalent.
4. Regulatory Review & Response
   We coordinate with regulators and provide clarifications if needed.
5. Approval & Compliance
   Once approved, we ensure labeling, PMS, and market compliance is maintained.