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

The Indian medical device industry is experiencing a period of expansion, presenting both possibilities for domestic and international players. To thrivingly operate within this evolving landscape, it is vital to have a clear understanding of the regulatory framework that oversees medical device development. This guide aims to deliver a concise ov… Read More

Entering the Indian medical device market presents a significant opportunity for businesses. However, navigating the approval process can be demanding. This guide seeks to a thorough understanding of the process involved in obtaining medical device registration in India. A successful registration journey starts with understanding the legal structur… 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