Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations – MD13

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Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

Central Licensing Authority (CLA): The Central Drugs Standard Control Organization (CDSCO) is responsible for granting this licence.

Application Portal

  • National Single Window System (NSWS) Portal: As of January 1, 2024, all applications for this licence must be submitted through the NSWS portal. 

The form required for License to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training 

Applicant Type

Application

License

Test License to Manufacture Medical Device

Form MD-12

Form MD-13

 

Fee Structure:

Subject

Fee (in rupees) INR

Test license to manufacture for clinical investigations, tests, evaluations, examinations, demonstrations, or training for each distinct medical device

500

 

Application Process

  1. Registration: Sign up on the NSWS portal to create an account.
  2. Application Submission: Fill out Form MD-12 and upload the required documents.
  3. Fee Payment: Pay the applicable fees through the portal.
  4. Evaluation and Query Resolution: The CLA will review the application and may raise queries. The applicant must address queries and implement corrective actions
  5. Licence Issuance: Upon successful verification of the file, the licence will be granted in Form MD-13.

Required Documents

According to the official checklist provided by CDSCO, the following documents are required for the Form MD-12 application:

  1. Covering Letter: Clearly stating the objective of the test licence.
  2. Brief Description of the Medical Device: Details about the device for which the licence is sought.
  3. Undertaking: A statement confirming that the necessary facilities, including equipment, instruments, and personnel, are available to manufacture the specified medical devices.
  4. List of Equipment and Instruments: Details of manufacturing and testing equipment relevant to the medical devices.
  5. List of Qualified Personnel: Information about personnel responsible for manufacturing and testing.
  6. Justification of Quantity: Rationale for the quantity of devices proposed to be manufactured, along with a utilization breakdown.
  7. Test Specifications and Protocols: Including applicable standards for the device.
  8. Manufacturing and Testing Process Description: A brief overview and flowchart of the processes.

Expected Timeline: 1-2 Months

Validity of License: 3 Year from the date of Issue