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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.

Ce document établit le cadre réglementaire de l'UE pour les dispositifs médicaux. Il fixe des normes élevées de qualité et de sécurité afin de garantir la protection des patients.

Le règlement (UE) 2017/746 établit un cadre réglementaire complet pour les dispositifs médicaux de diagnostic in vitro, garantissant des normes de sécurité et de qualité élevées tout en soutenant l'innovation et l'harmonisation du marché.

Ce document d'orientation présente le processus d'enregistrement obligatoire auprès de la CDSCO pour l'importation de cosmétiques en Inde. Il détaille les formulaires en ligne, les documents et les frais requis.