Germany's regulatory/legal/official landscape for pharmaceutical products is governed by the strict/robust/comprehensive guidelines set forth by the Competent Authority/Regulatory Body/Supervisory Organization. Compliance with these regulations/directives/standards is mandatory/essential/crucial for any entity involved in the development/manufactur… Read More

Gaining entry into the Indian medical device market requires a comprehensive understanding of its stringent regulations. To ensure smooth licensing, manufacturers must meticulously conform with all applicable requirements. This entails conducting thorough risk assessments, obtaining necessary certifications, and submitting thorough applications to … Read More

Securing regulatory approval for medical devices in India can be a demanding process. Aspiring manufacturers must traverse a stringent regulatory system governed by the Central Drugs Standard Control Organization (CDSCO). The approval route involves submitting detailed requests, complying with stringent quality and safety standards, and undergoing … Read More

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices in accordance with the Medical Device Rules 2017 India. For medical device registration India on the Sugam portal, one essential requirement is the submission of a Plant Master File (PMF). This document provides detailed information about the legal manufactu… Read More