CDSCO Manufacturing licence

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Get Your CDSCO Manufacturing License for Medical Devices With Expert Assistance

If you are planning to manufacture medical devices in India, obtaining a CDSCO manufacturing license for medical devices is a mandatory regulatory requirement. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, is India’s national regulatory authority that ensures the safety, quality, and performance of medical devices before they are released into the market. Without this license, medical device manufacturers cannot legally manufacture or distribute their products in India.

What is a CDSCO Manufacturing License for Medical Devices?

The CDSCO manufacturing license is an official approval granted by the Central Licensing Authority (CLA) or State Licensing Authority (SLA) that legally permits a manufacturer to produce medical devices in India.

The license signifies that:

  • The manufacturer meets regulatory standards laid down under MDR 2017.
  • The devices meet ISO 13485:2016 quality management system requirements.
  • The products ensure safety, performance, and effectiveness.
  • Without this license, manufacturers cannot manufacture or market their products in the Indian market.

Why Do You Need a CDSCO Manufacturing License for Medical Devices?

  • Here are the top reasons why this license is essential:

    • Regulatory Requirement – By law, no manufacturing of medical devices can take place in India without prior approval from the CDSCO.
    • Market Authorization – It gives manufacturers the legal right to manufacture and sell devices across India.
    • Safety & Efficacy Assurance – Licensing ensures that devices are safe for patients and comply with international benchmarks.
    • Global Market Access – Many foreign regulators recognize CDSCO’s approval, boosting export opportunities.
    • Trust Factor – Hospitals, clinics, and healthcare providers prefer licensed manufacturers for procurement, as it assures quality and compliance.

Classification of Medical Devices

Understanding the classification of devices is crucial because the licensing authority and documentary requirements differ according to the class.

Medical Devices Risk Level Examples Licensing Authority
Class A
Low Risk
Aerosol delivery tubing, Apgar timer
State Licensing Authority (SLA)
Class B
Low to Moderate Risk
Medical bassinet,Aerosol face mask
State Licensing Authority (SLA)
Class C
Moderate to High Risk
anaesthesia vaporizer, MRI machines
Central Licensing Authority (CLA)
Class D
High Risk
Spinal needle bioimpedance navigation unit,Ventricular bypass (assist) device
Central Licensing Authority (CLA)

Step‑by‑Step CDSCO Manufacturing License Process

Here is the detailed process for applying for a CDSCO manufacturing license for medical devices:

Identify the Correct Device Classification

  • Manufacturers must determine the correct class (A, B, C, or D) as per MDR 2017. Incorrect classification results in delays and rejections.

Register on the CDSCO Medical Device Portal

  • All applications are filed online via CDSCO Medical Device . Create an account, verify details, and submit your application accordingly.

Prepare Documentation

  • The applicant must submit: Technical Documentation – complete product details, design, intended use, IFU, label,  risk management file, product verification and validation reports, clinical evaluation report  and post market surveillance.
  • Plant Master File (PMF) – Contains details of manufacturing facility, QMS certification, processes, machinery, personnel.

Apply in Prescribed Forms

  • Form MD‑3 – For Class A & B medical device manufacturing license.
  • Form MD‑7 – For Class C & D medical device manufacturing license.

Inspection of Manufacturing Premises

  • Class A & B: State Licensing Authority (SLA) inspects the premises.
  • Class C & D: CDSCO (Central Licensing Authority) conducts inspections.
  • Compliance with ISO 13485 Quality Management System standards is mandatory for the facility.

Evaluation & Clarifications

  • The authority may seek additional data, clarifications, or corrections during review.

Grant of License

On approval:

  • Class A & B manufacturers receive licenses – SLA.
  • Class C & D manufacturers receive licenses – CLA.

Documents Required for CDSCO Manufacturing License

For smooth approval, applicants must ensure complete and correct documentation. General documents required include:

  • MD- 13 Test License
  • Covering letter
  • Device Master File (DMF)
  • The Establishment /Site ownership /Tenacy Agreement
  • Premises ownership or lease agreement
  • Fees receipt from the SUGAM portal
  • Copy of MD-27 – if device without predicate
  • Plant Master File (PMF)
  • Quality Management System certificate (ISO 13485:2016)

Validity & Renewal of CDSCO Manufacturing License

  • Validity: The license is generally valid for 5 years from the date of issue.
  • Renewal: Application for renewal should be filed at least 6 months before expiry.
  • Post‑marketing obligations: Manufacturers must maintain records of complaints, recalls, and adverse events.

Common Challenges Manufacturers Face

  • Complex Documentation: Preparing DMF and PMF requires in‑depth technical and regulatory expertise.
  • Device Classification Ambiguity: Errors in classification lead to unwanted delays.
  • Regulatory Amendments: CDSCO regulations are evolving; keeping track is challenging.
  • Inspection Readiness: Many facilities fail in audits due to poor documentation or infrastructure gaps.
  • Time Delays: Obtaining clarifications from CDSCO can stretch timelines by months.

How Medfins Helps

At this stage, many manufacturers prefer hiring regulatory consultants to ease the licensing process. Expert consultants provide:

  • Accurate classification of devices.
  • Preparation and review of DMF/PMF.
  • End‑to‑end filing assistance on CDSCO Medical device portal.
  • Facility audit preparation and mock inspections.
  • Compliance updates.
  • Post Approval support if required

Our Services for CDSCO Manufacturing License for Medical Devices

As a trusted regulatory partner, we ensure your licensing process is smooth, fast, and compliant. Our services include:

  • CDSCO Registration & Filing: Complete support for MD‑5/MD‑9
  • Documentation Support: Assistance in preparing Device Master File (DMF) and Plant Master File (PMF).
  • ISO 13485 Certification Guidance: Helping you achieve quality compliance.
  • Audit Preparation: Mock inspections to ensure 100% readiness.
  • Post‑License Assistance: Renewal, modifications, and change approvals.

FAQs on CDSCO Manufacturing License for Medical Devices

The government fees vary depending on device class and number of devices. FeePaidDetails