Form MD-22: This is the application form submitted to the Central Licensing Authority (CLA) (i.e., DCGI under CDSCO) to seek permission for conducting a clinical investigation of a new medical device or an investigational medical device without a predicate device in India.

Form MD-23: If the CLA is satisfied with the application, it grants permission to conduct the clinical investigation through Form MD-23. This permission allows the sponsor to begin the study in accordance with an approved clinical investigation plan reviewed by a registered Ethics Committee.

Additional requirements:

  • The clinical investigation must be registered with the Clinical Trials Registry – India (CTRI) before the enrolment of the first participant.

  • The first participant must be enrolled within one year of the grant of permission; otherwise, fresh permission from the CLA is required.