Indian Regulators Consider Pre-Submission Consulting for Medical Device Registrants
India’s Central Drugs Standard Control Organization (CDSCO) is seeking comment on a new proposal to establish formal pre-submission consultations with firms seeking medical device registration in the country. The consultations would apply to devices as well as drugs and clinical trials.
Emergo consultants in India explain that the consultations, known as Pre-submission Meetings or PSM, are meant to provide more transparency and predictability to the Indian registration process. If regulators decide to implement the PSM component, registration steps would occur as follows:
- Applicant requests a PSM for a new medical device approval
- Applicant submits all relevant information on the proposed regulatory pathway for its device based on requirements in the Drugs and Cosmetic Act and Rules
- CDSCO examines submitted materials and notifies applicant of specific date and time for PSM
- At PSM, applicant presents proposed regulatory pathway for its device to CDSCO and any experts in attendance
- Applicant and CDSCO will deliberate proposed regulatory pathway
- Regulatory pathway is then determined based on applicant’s presentation
- PSM minutes recorded and signed by CDSCO and applicant
- Copy of PSM minutes are provided to applicant for inclusion in formal registration application
If adopted, PSMs will be optional for applicants—firms may still forego such meetings and submit their applications directly to CDSCO.
To learn more about India's regulatory pathways for medical devices, view our overview of the Indian medical device market.