Medical Device Rules 2017 are framed to ensure the credibility of clinical data and the protection of human subjects. Clinical study should be conducted in accordance with good clinical practice guidelines issued by the CDSCO with the protocol approved by the registered ethics committee and performed on subjects from whom the informed consent is obtained.
Procedure to obtain permission to conduct Clinical Investigation of Medical Device
The permission for clinical investigation of investigational medical device may be obtained from the Central Licensing Authority by submitting an application in Form MD-22 along with the data specified in Seventh Schedule. For pilot clinical investigation i.e. clinical investigations for the first time in human, the application should be accompanied by the fee as specified in the second schedule. For pivotal clinical investigation, it should be accompanied by the fee as specified in the second schedule and the data from the pilot clinical investigation. The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirement of animal data or clinical data to conduct clinical investigation. If the requirements of the rules are complied with, the Central Licensing Authority may grant the permission in Form MD-23 or reject the application within 90 days from the date of application.
No fee is required, if the institute, organisation, hospital is run or funded by the Central Government or the State Government. No permission is required for academic clinical study on licensed medical device if the Ethics Committee approves the study and the data generated during the study will not to be used for furnishing before the Central Licensing Authority to obtain import or manufacturing licence.
Medical devices requiring clinical investigation but claiming substantial equivalence to a predicate device must be marketed only after the approval Central Licensing Authority. The Central Licensing Authority has the authority to impose or exempt any condition while granting permission for clinical investigations regarding the objective, design, subject population, subject eligibility, assessment, conduct and treatment of clinical investigation.
Conditions for Permission
The clinical investigation plan must be approved by the ethics committee before the start of clinical investigation and registered with the clinical trial registry of India. The clinical investigation should be conducted in accordance with the approved clinical investigation plan, Good Clinical Practices Guidelines issued by the Central Drugs Standard Control Organisation and provisions of the Seventh Schedule. The first participant must be enrolled within one year from the date of grant of permission, failing which prior permission from the Central Licensing Authority is required to initiate clinical investigation.
The premises of the sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical investigation sites are subjected to inspection by officers of the Central Licensing Authority who may be accompanied by officers of the State Licensing Authority or outside experts, for verification of compliance. However, such inspections are performed only with the prior approval of the Central Licensing Authority. The names, addresses and other particulars of persons involved in clinical investigation must be disclosed to such regulatory authorities. Annual status report of clinical investigation like ongoing, completed or terminated study must be provided to the Central Licensing Authority and in case of termination of clinical investigation, the detailed reasons for the same must be provided within 30 days of such termination. The documents, records and data related to the clinical investigation must be maintained for the period of seven years after the completion of investigation and must be furnished to the Central Licensing Authority or any officer designated by him.
Any Serious adverse events occurring during the clinical investigation must be reported within 14 days of its occurrence as specified in the seventh schedule and in case of injury or death, the applicant must provide complete medical management and compensation as specified under rule 122AB of the Drugs and Cosmetics Rules, 1945. In case of death, the compensation must be provided to the legal heir of the participant.
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