The German medical device regulatory landscape presents challenging hurdles for manufacturers seeking to expand into the European market. The Central Drug Standard Control Organization (CDSCO) of India, while focussed on domestic regulations, also plays a role in facilitating the international path of Indian medical device companies. This guide pro… Read More

India's burgeoning healthcare industry presents numerous opportunities for medical device manufacturers. However, entering this market requires a thorough understanding of the regulatory landscape. The process of registering medical devices in India is governed by the Central Drugs Standard Control Organization (CDSCO). Manufacturers must adhere s… Read More

Entering the Indian market for medical devices presents a unique challenge for manufacturers. To successfully launch in this growing sector, it's crucial to comply with the regulatory framework set by the Central Drugs Standard Control Organization (CDSCO). The CDSCO registration process can seem intricate, but by following a structured approach an… 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