Entering the German market provides a lucrative opportunity for manufacturers in the pharmaceutical and medical device sectors. However, efficiently navigating the regulatory landscape is crucial to guarantee compliance with stringent standards set by the Central Drugs Standard Control Organisation (CDSCO). This guideline outlines key aspects of Ge… Read More

The Indian medical device regulatory terrain can be a complex navigational obstacle for manufacturers. This guide aims to provide a concise comprehension of the essential policies governing the development , acquiring, and promoting of medical devices in India. Here, we enumerate some significant aspects to factor in: * Accreditation: All makers o… Read More

Securing official approval for medical devices in India can be a multifaceted process. Aspiring manufacturers are required to traverse a rigorous regulatory system governed by the Central Drugs Standard Control Organization (CDSCO). The approval pathway involves presenting detailed requests, adhering with stringent quality and safety specifications… 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