Navigating the demanding regulatory landscape in Germany requires a comprehensive understanding of the applicable laws and guidelines. The Central Drugs Standard Control Organization (CDSCO) plays a significant role in overseeing medicinal products within the country, promoting safety and efficacy. Companies pursuing to supply CDSCO-regulated pr… Read More

Medical device import registration in India can be a complex process. Companies seeking to introduce their products into the country must meet stringent standards. A successful import journey often involves careful planning and collaboration with relevant authorities. Important steps include performing a thorough analysis to pinpoint mar… Read More

Entering the Indian medical device market requires a thorough understanding of its stringent registration process. To guarantee regulatory compliance and market access, manufacturers must navigate a complex system. This involves submitting comprehensive applications to the Central Drugs Standard Control Organisation (CDSCO) along with requisite … Read More

The process of registering a medical device with the Central Drugs Standard Control Organisation (CDSCO) can seem challenging. However, with a structured approach and understanding of the requirements, you can effectively navigate this process. This resource aims to furnish you with the necessary information to facilitate a successful registrati… 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 manufa… Read More