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.

This document explains CDSCO's grouping guidelines for medical devices and IVDs under the Medical Devices Rules, 2017, covering fee structures and documentation requirements for Single, Family, System, Group, and IVD Cluster categories.

This CDSCO document outlines regulatory guidelines for In-Vitro Diagnostic (IVD) medical devices in India under the Medical Devices Rules, 2017. It details classification, licensing, and quality standards for importing and manufacturing.

Morulaa HealthTech leverages existing Indian device files to streamline international registrations. Their strategy uses direct mapping and expert preparation to simplify global expansion.

This document provides frequently asked questions and addenda outlining the Central Drugs Standard Control Organization's regulatory framework for medical device classification, manufacturing, and import.

The Cosmetics Rules, 2020, regulate the import, manufacture, and sale of cosmetics in India, mandating standardized registration, labeling, and quality testing to ensure consumer safety.

This document outlines updated CDSCO post-approval correction categories for medical devices. It distinguishes between major and minor changes involving manufacturing, administrative, and design updates.

This document classifies in-vitro diagnostic medical devices into risk classes based on intended use and clinical impact, following India's Medical Devices Rules, 2017.

The Medical Devices Rules, 2017 establish a risk-based framework regulating the classification, manufacture, import, clinical investigation, and sale of devices.

The Plastic Waste Management Rules, 2016, mandate source segregation, recycling, and extended producer responsibility. They require registration for manufacturers and specify a minimum thickness of fifty microns for plastic products.