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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.

This document establishes the EU regulatory framework for medical devices. It sets high standards for quality and safety to ensure patient protection.

Regulation (EU) 2017/746 establishes a comprehensive regulatory framework for in vitro diagnostic medical devices, ensuring high safety and quality standards while supporting innovation and market harmonization.

This guidance document outlines the mandatory CDSCO registration process for importing cosmetics into India. It details required online forms, documentation, and fees.