Introduction

is a mandatory regulatory requirement for entities involved in the In India, the regulation of medical devices is overseen by the Central Drugs Standard Control Organization (CDSCO). For businesses involved in the import or manufacture of Class C and D medical devices, obtaining the relevant licenses—MD-15 (Import License) and Manufacturing Licenses—is mandatory to comply with the provisions of the Medical Devices Rules, 2017.

This guide provides an overview of the requirements, procedures, and benefits of these licenses.

Class C and D medical devices are classified as high-risk medical devices. They include:

• Class C: Devices with medium- to high-risk factors (e.g., infusion pumps, ventilators).
• Class D: Devices with the highest risk factors, typically used for life-sustaining purposes (e.g., heart valves, pacemakers).

These devices require stringent regulatory compliance to ensure safety, efficacy, and quality.

The MD-15 Import License allows entities to import medical devices classified under Class C and D into India. It is issued by CDSCO after a detailed evaluation of the importer’s compliance with regulatory standards.

Key Features:

• Valid for a specified period, subject to renewal.
• Required for importing Class C and D devices from international manufacturers.
• Ensures compliance with Indian medical device regulations.

The manufacturing license permits companies to produce Class C and D medical devices in India. This license is crucial for ensuring the quality of devices produced for domestic and international markets.

Key Features:

• Allows the manufacturing of high-risk devices.
• Mandatory for production facilities under CDSCO’s jurisdiction.
• Requires detailed documentation, audits, and certifications.

Steps to Obtain an MD-15 Import License

1. Prepare Required Documents

o Application in Form MD-14.
o ISO 13485 certificate for quality management systems.
o Free Sale Certificate (FSC) or CE Certificate from the exporting country.
o Details of the importer, manufacturer, and products.

2. Submit the Application

o Apply through the CDSCO’s online platform (SUGAM portal).

3. Review & Approval

o The CDSCO reviews the application for completeness and compliance.

4. Grant of License

o Upon approval, MD-15 is issued for the specified devices.

Steps to Obtain a Manufacturing License for Class C and D Devices

1. Set Up a Manufacturing Facility

o Ensure your facility complies with Good Manufacturing Practices (GMP) as per Schedule V of the Medical Device Rules.

2. Prepare Documentation

o ISO 13485 certification.
o Risk management and clinical data.
o Details of manufacturing processes, equipment, and quality controls.

3. File the Application

o Submit Form MD-3 or MD-4 (depending on the category).

4. Inspection by Authorities

o CDSCO officials conduct on-site inspections to verify compliance.

5. License Issuance

o Upon successful inspection, the manufacturing license is granted.

• Legal Compliance: Avoid penalties for non-compliance.
• Market Access: Legally market and distribute high-risk devices in India.
• Product Safety: Ensure devices meet safety and efficacy standards.
• Global Recognition: Enhance credibility with regulatory approvals.

Navigating the regulatory landscape for Class C and D medical devices can seem challenging, but with the right guidance and preparation, obtaining a CDSCO MD-15 Import License or Manufacturing License is straightforward.

For assistance with documentation, compliance, or application processes, contact us today and ensure a seamless experience in meeting CDSCO’s regulatory requirements..

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