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CDSCO Guidance — By Topic

CDSCO publishes guidance documents, office memoranda, and circulars on the CDSCO website. Key guidance topics include:

TopicDocument type
Import licence application requirementsOffice memoranda, SUGAM help documents
SUGAM portal user guidesPortal guidance
UDI implementation guidanceCDSCO circular
Vigilance reporting (MDVP)Schedule 7 guidance
Clinical investigation requirementsND&CT Rules guidance
GMP / Schedule 5 guidanceICMED/QCI documents
IMDRF guidance adopted by CDSCOAdoption notices
BIS standards applicable to devicesBIS standards index

For the most current list, visit CDSCO — Medical Devices Guidance.

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CDSCO guidance is not always published as standalone documents. Many requirements are communicated through office memoranda and gazette notifications. Monitor the CDSCO website and What's New regularly.