Manufacturing medical devices in India—especially Class C and Class D devices—requires proper regulatory approval from the Central Drugs Standard Control Organization (CDSCO). One such crucial approval is the MD-42 license, issued under the Medical Device Rules, 2017. This guide explains everything manufacturers need to know about the MD-42 license in India, including its purpose, process, documents required, and how to stay compliant with Indian medical device regulations.

What is an MD-42 License?

The MD-42 license is issued by CDSCO to manufacturers who produce Class C or Class D medical devices in India. These classes are categorized as moderate to high-risk devices, such as:

1. Dialysis equipment

2. Orthopedic implants

3. Infusion pumps

4. Blood bags

5. Cardiac stents

6. Ventilators

These products have direct impacts on human health and thus require stricter oversight. The MD-42 license is mandatory before starting commercial manufacturing or distribution of such devices in the Indian market.

Who Should Apply for an MD-42 License?

Any company or individual intending to manufacture, assemble, sterilize, label, or package Class C or D medical devices in India must obtain an MD-42 license. This license ensures that the manufacturer meets quality, safety, and regulatory standards defined by CDSCO.

Importers, on the other hand, require a different license (MD-15), while manufacturers of Class A and B devices must obtain an MD-5 license from the State Licensing Authority.

Eligibility Criteria for MD-42 License

To qualify for the MD-42 license, the applicant must:

1. Own a dedicated manufacturing facility compliant with Good Manufacturing Practices (GMP)

2. Employ qualified technical staff, including a Production Head and Quality Assurance (QA) Head

3. Ensure adequate infrastructure, controlled environments (cleanrooms), and testing labs

4. Maintain and follow a Quality Management System (QMS) aligned with ISO 13485 (preferred)
   
   Documents Required for MD-42 License Application

Applicants must submit a set of essential documents through the CDSCO SUGAM online portal. Key documents include:

1. Site Master File and Device Master File

2. Plant layout and facility details

3. List of equipment, machinery, and instruments

4. Product specifications and intended use

5. ISO 13485 certificate (optional but beneficial)

6. Details of qualified technical staff

7. Copies of test reports and validation certificates

8. Manufacturing and testing SOPs

9. Product labels and artwork

10. Challan or proof of fee payment

Ensuring that all documents are complete and accurate significantly reduces the chances of rejection or delays in processing.

Step-by-Step Process to Obtain MD-42 License

1. Registration on CDSCO SUGAM Portal
   Create a user ID and register your manufacturing unit on the official portal.

2. Application Filing via Form MD-7
   Fill out Form MD-7 with details about the manufacturing site, technical personnel, and devices intended to be manufactured.

3. Upload Required Documents
   Submit all the necessary documents, including declarations and undertakings.

4. Fee Payment
   Pay the prescribed government fee through Bharatkosh and upload the receipt.

5. Inspection by Regulatory Authority
   CDSCO may conduct a physical inspection of your facility to verify compliance with safety and quality norms.

6. Issuance of License (Form MD-42)
   If all conditions are met, CDSCO will issue the MD-42 license to the manufacturer.
   

Validity and Renewal

The MD-42 license remains valid indefinitely, provided the license retention fee is paid every five years as per the latest amendment. Failure to do so may result in suspension or cancellation of the license.

Why Compliance Matters

Operating without a valid MD-42 license for Class C and D devices is a punishable offense under Indian law. Moreover, regulatory non-compliance can result in heavy penalties, product recalls, and damage to brand credibility. Obtaining the MD-42 license not only ensures legal operation but also builds customer trust and opens opportunities for export.

Need Help with MD-42 Licensing?

The licensing process can be complex and time-consuming, especially for new entrants in the medical device sector. At PSR Compliance, we help businesses prepare documents, complete registration, respond to compliance queries, and secure their MD-42 license hassle-free.

To learn more about the MD-42 license process, visit our detailed guide here:
👉 https://www.psrcompliance.com/blog/md-42-license-in-india