Feb 2, 2015
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:
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.
India’s Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing.
Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes:
India’s health ministry plans to push forward its proposed amendments to the country’s Drugs and Cosmetics Act that would