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The software intended to be used for medical purposes (Medical Device Software) are also regulated under the said provisions ensuring their quality, safety and performance.

This draft notification proposes amendments to the Medical Devices Rules, 2017. It revises the timelines and procedures for application, site audits, and Quality Management System compliance verifications.

Official CDSCO guidance document outlining the Subject Expert Committee's composition, application review processes, evaluation questions, applicant responsibilities, and standardized presentation structures for drug approvals.

This document outlines the required application checklist under the Medical Devices Rules 2017, for importing or manufacturing medical devices in India that do not have a predicate device.

This document outlines the mandatory and optional checklist requirements for medical device applications using Form MD-26. It details specific technical, safety, regulatory, and pharmaceutical documentation required for both fresh applications and endorsements.

This EU regulation establishes harmonised rules for the entire life-cycle of packaging. It sets mandatory sustainability requirements, waste prevention targets, re-use mandates, and recycling standards across all Member States.

Questo documento stabilisce il quadro normativo dell'UE per i dispositivi medici. Definisce standard elevati di qualità e sicurezza per garantire la protezione dei pazienti.

Il regolamento (UE) 2017/746 stabilisce un quadro normativo completo per i dispositivi medico-diagnostici in vitro, garantendo elevati standard di sicurezza e qualità e sostenendo al contempo l'innovazione e l'armonizzazione del mercato.

Questo documento di orientamento delinea il processo obbligatorio di registrazione presso la CDSCO per l'importazione di cosmetici in India. Spiega in dettaglio i moduli online richiesti, la documentazione e le tariffe.