The central drugs standard control organisation (cdsco) under directorate general of health services,ministry of health & family welfare,government of india is the national regulatory. The document provides frequently asked questions regarding medical device regulations by the central drugs standard control organization (cdsco) in india, addressing topics such as. The central drugs standard control organisation (cdsco) under directorate general of health services,ministry of health & family welfare,government of india is the national regulatory.
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Medical device division of cdsco (central drugs standard control organization) releases faq document on periodical basis to clarify the frequently raised questions by industry and. The central drugs standard control organization (cdsco) in india has introduced new guidelines in 2025 for medical device registration, which bring several key changes that could impact manufacturers. 09 july 2025 doc no.
Whether the intended use of a medical device as mentioned in the cdsco classification list is to be adhered by the applicant while submitting application for obtaining manufacturing/import license for.
2025 faq (frequently asked questions) released date: Navigating india medical device regulations (mdr 2017) with our 2025 cdsco regulatory guidelines on import license,approval process,labeling and compliance faqs. The replies to the faqs are aimed only for creating public awareness about medical devices regulation by cdsco and are not meant to be used for legal or professional purposes.
