CDSCO Manufacturing & Import License Registration for Medical Devices

Introduction

India’s healthcare market is expanding rapidly, and so is the demand for high-quality medical devices. To protect patient safety and maintain consistent standards, the Central Drugs Standard Control Organization (CDSCO) regulates the manufacture and import of medical devices under the Drugs and Cosmetics Act, 1940 and the Medical Device Rules, 2017.
Any business that wishes to manufacture or import medical devices into India must secure a CDSCO Certification,  Whether you are a domestic producer or an overseas supplier, understanding this licensing process is critical for legal compliance and long-term success.

Why CDSCO Licensing Is Essential

1. Patient Safety: Medical devices come into direct contact with patients. CDSCO Registrat ion for Medical Devices that every approved device meets stringent safety and quality requirements.
   
   

2. Market Access: Without a valid manufacturing or import license, products cannot be legally marketed or distributed in India.
   
   

3. Global Credibility: CDSCO certification demonstrates adherence to internationally recognized standards, which helps manufacturers gain trust among healthcare providers and end users.
   
   

4. Regulatory Consistency: Licensing helps the government maintain a transparent, standardized system for evaluating products and addressing complaints or recalls.
   
   

Categories of Medical Devices

Medical devices in India are classified into four categories based on risk:

• Class A – Low risk (e.g., surgical dressings, simple instruments)
  
  

• Class B – Low-moderate risk (e.g., hypodermic needles, infusion sets)
  
  

• Class C – Moderate-high risk (e.g., ventilators, bone fixation plates)
  
  

• Class D – High risk (e.g., heart valves, implantable pacemakers)
  
  

The classification determines the level of scrutiny and the type of license required. Manufacturers and importers must carefully identify the correct class before starting the application.

Manufacturing License Registration

Domestic manufacturers need a CDSCO Registration, manufacturing license if they produce any Class A, B, C, or D device. The main steps are:

1. Determine Device Class and Appoint an Authorized Person
   
   

• Identify the appropriate risk category.
  
  

• Designate a technically qualified person (commonly a biomedical engineer or pharmaceutical professional) to oversee regulatory compliance.
  
  

2. Prepare the Application
   
   

• Use Form MD-3 for Class A & B, and Form MD-7 for Class C & D devices.
  
  

• Include site master files, quality manuals, device master files, and details of raw materials, equipment, and testing facilities.
  
  

3. Quality Management System (QMS) Compliance
   
   

• Implement a QMS aligned with ISO 13485 or an equivalent standard.
  
  

• Internal audits and calibration records must be available for inspection.
  
  

4. Site Inspection and Evaluation
   
   

• The State Licensing Authority (for Class A & B) or CDSCO (for Class C & D) may conduct a physical inspection.
  
  

• Inspectors review documentation, testing procedures, and manufacturing practices.
  
  

5. Grant of License
   
   

• Once satisfied, authorities issue the license in Form MD-5 (for A & B) or Form MD-9 (for C & D).
  
  

• Licenses are valid for five years, subject to timely renewals and compliance checks.
  
  

Import License Registration

Foreign manufacturers who wish to sell medical devices in India must obtain an import license. The process includes:

1. Authorized Indian Agent
   
   

• Non-Indian manufacturers must appoint an Authorized Agent in India with a valid wholesale license.
  
  

• This agent communicates with CDSCO and ensures ongoing regulatory compliance.
  
  

2. Device Classification and Registration
   
   

• Identify the risk class and check if the device is listed in the notified category.
  
  

• Submit a Form MD-14 application for an import license.
  
  

3. Technical Documentation
   
   

• Provide detailed device master files, certificates of free sale from the country of origin, ISO 13485 certification, and clinical evidence of safety and performance.
  
  

4. Fees and Payment
   
   

• Fees vary according to the class of device and the number of models.
  
  

• Payment is made online through the SUGAM portal.
  
  

5. Review and Approval
   
   

• CDSCO reviews documentation and may request additional data or clarifications.
  
  

• After approval, the import license is issued in Form MD-15, typically valid for five years.
  
  

Key Compliance Requirements

• Post-Market Surveillance: Both manufacturers and importers must monitor device performance and report adverse events promptly.
  
  

• Labeling Norms: All products must follow Indian labeling rules, including details such as manufacturing date, batch number, and importer contact information.
  
  

• Change Notifications: Any significant change in manufacturing process, design, or authorized agent must be reported to CDSCO without delay.
  
  

• Renewal & Retention: Licenses require periodic renewals and payment of retention fees to remain valid.
  
  

Common Challenges

Many businesses face hurdles such as incomplete documentation, delays in site inspections, or misclassification of devices. To avoid these pitfalls:

• Conduct a thorough gap analysis of your QMS before applying.
  
  

• Maintain clear communication with your authorized agent or regulatory consultant.
  
  

• Keep all technical files up to date, especially clinical evaluation reports.
  
  

Benefits of Early Compliance

Timely registration offers tangible advantages: