Comprehensive Guide to Preparing a Plant Master File (PMF) for Medical Device Registration in India
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 on the Sugam portal, one essential requirement is the submission of a Plant Master File (PMF). This document provides detailed information about the legal manufacturing site, covering its processes, facilities, […]
Preparing a Device Master File (DMF) as per the Medical Device Rules, 2017: A Guide by Morulaa HealthTech
Morulaa HealthTech, as the leading consultant in India for medical devices, simplifies the preparation of the Device Master File (DMF) in compliance with the Medical Device Rules and regulation (India MDR, 2017). Acting as your authorized agent in India, Morulaa ensures the DMF meets the regulatory requirements of the CDSCO medical device guidelines and is […]