The MD-42 License is a mandatory authorization required for the manufacturing or import of specific medical devices in India under the Medical Device Rules (MDR), 2017. As India continues to strengthen its regulatory framework for healthcare products, obtaining the correct licenses has become essential for businesses dealing in medical devices. The MD-42 License plays a key role in ensuring that only compliant and quality-assured devices reach the market, ultimately protecting patient safety and supporting industry accountability.
What is the MD-42 License?
Under the MDR 2017, various forms are issued to regulate medical devices. The MD-42 License specifically allows companies to manufacture Class C and Class D medical devices. These are high-risk devices such as life-sustaining, implantable, or critical care equipment. Because of the higher risk classification, the MD-42 License involves strict scrutiny of the manufacturing site, quality control systems, and technical documentation.
For manufacturers, this license acts as a proof of compliance with Good Manufacturing Practices (GMP), quality protocols, and safety requirements. Importers working with foreign manufacturers must also ensure that the devices they source are produced in facilities holding MD-42-equivalent regulatory approvals.
Why is MD-42 License Important?
Medical devices in Class C and D categories are highly sensitive and directly impact human life. Therefore:
Regulatory compliance becomes non-negotiable.
Only licensed manufacturers can legally produce or supply these devices.
It provides market authorization and confidence for hospitals, distributors, and healthcare providers.
It ensures traceability, accountability, and long-term safety monitoring.
Additionally, the MD-42 License helps India align with global quality standards, thereby supporting export opportunities and boosting trust in Indian-made medical devices.
Eligibility & Requirements for MD-42 License
To obtain the license, applicants must fulfill several requirements:
A fully compliant manufacturing unit with quality management systems as per ISO 13485.
A qualified authorized signatory and technical staff.
Complete device master file (DMF) and plant master file (PMF).
Proof of adequate infrastructure, testing equipment, and environmental controls.
Submission of safety and performance data depending on the device type.
Authorities may conduct an audit/inspection before granting the license, ensuring that the facility meets all regulatory standards.
Application Process for MD-42 License
The process is conducted through the CDSCO online portal:
Registration on CDSCO SUGAM Portal
Preparation of required documents including DMF, PMF, QMS certificates, and declarations
Filing the MD-42 application with government fee
Review by CDSCO authorities
Site inspection (if applicable)
Grant of MD-42 License
The timeline generally ranges between 60–120 days, depending on the completeness of documents and the complexity of the device.
How Professional Assistance Helps
The MD-42 licensing process involves technical documentation and regulatory understanding. Any error or missing detail can lead to delays or rejections. Many manufacturers prefer professional compliance services to streamline the process and ensure accuracy.