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CDSCO Medical Device Registration Services

CDSCO Medical Device Registration Services, governed by the Ministry of Health and Family Welfare, is the regulatory authority responsible for overseeing the safety, quality and performance of medical devices. Registration with CDSCO is mandatory for all manufacturers and importers of regulated medical devices to ensure compliance with the Medical Devices Rules, 2017.

CDSCO Medical Device Registration certifies that the device meets the required safety and performance standards, making it eligible for sale and distribution. Whether you're a domestic manufacturer or a global exporter, complying with these regulations is essential for market access and credibility.

Key Services We Offer

  • Product Classification and Eligibility Assessment : We assess your medical devices to determine their classification (Class A, B, C or D) as per CDSCO guidelines and identify whether they fall under the notified medical device category requiring registration.
  • Documentation Preparation and Review : Our experts assist in preparing all necessary documents with precision, ensuring compliance with CDSCO requirements, including:
    • Application Form MD-14 or MD-15
    • Device Master File (DMF)
    • Technical Documentation
    • ISO 13485 Certificate
    • Free Sale Certificate (FSC) for imported devices
    • Clinical Evaluation Reports (if applicable)
  • Device Testing and Standards Compliance : We ensure that your device complies with the applicable national and international standards, facilitating testing and evaluation where required.
  • Authorized Indian Agent Support for Foreign Manufacturers : For foreign manufacturers, we act as the Authorized Indian Agent (AIA) to represent your interests and facilitate the registration process with CDSCO.
  • Application Submission and Liaison with CDSCO :We handle the submission of your application to CDSCO and act as your liaison, addressing queries, providing additional documentation and ensuring timely updates.
  • Post-Registration Support :After obtaining registration, we offer ongoing compliance management, including renewal services, amendments and support for any regulatory audits or inspections.

Benefits of CDSCO Medical Device Registration

  • Legal Market Access :Obtain the necessary approvals to legally sell and distribute your devices.
  • Enhanced Credibility :Registration demonstrates compliance with stringent regulatory standards, building trust among healthcare professionals and consumers.
  • Global Recognition :CDSCO registration ensures your device is aligned with international quality and safety standards, enhancing global market opportunities.
  • Risk Mitigation :Registration ensures that your device complies with safety regulations, minimizing the risk of legal or financial liabilities.

Documents Required for CDSCO Registration

To obtain CDSCO Registration, must submit specific documents:

  • Covering letter
  • Application form (MD-14 or MD-15)
  • Device Master File (DMF)
  • Plant Master File (PMF)
  • ISO 13485 certificate
  • Free Sale Certificate (FSC) for imports
  • Clinical investigation reports (if required)
  • Performance evaluation data

Let Ornate Quality Services Pvt. Ltd. handle the complexities of CDSCO Medical Device Registration, so you can bring your innovative medical devices to the market confidently.

FREQUENTLY ASKED QUESTIONS (FAQ)

1. What is CDSCO?

It’s India’s national regulatory body for drugs and medical devices.

2. Why is CDSCO approval required?

To ensure product safety, quality, and efficacy in India.

3. Who issues CDSCO licenses?

The Drugs Controller General of India (DCGI).

4. How long does CDSCO approval take?

Usually 6–9 months, depending on the product type.

5. Is CDSCO approval mandatory for imports?

Yes, all imported drugs and medical devices need CDSCO approval.