The Central Drugs Standard Control Organisation (CDSCO), operating under the Directorate General of Health Services, Ministry of Health and Family Welfare, has issued a landmark draft document titled “Guidance document for Manufacturers for In-Vitro Diagnostic Medical Device” to standardize the domestic regulatory framework for diagnostic technologies. Designed as an operational manual for both domestic and international manufacturers, the guidance outlines step-by-step procedures for preparing and submitting manufacturing license applications through India’s designated digital portals, including the cdscomdonline platform and the National Single Window System (NSWS). By formalizing technical, clinical, and quality documentation under the Medical Devices Rules (MDR), 2017, the regulatory blueprint aims to eliminate dossier discrepancies, streamline regulatory verification, and ensure the consistent market availability of high-quality diagnostic products.
Structured across 10 comprehensive sections and detailed regulatory annexures, the guidance establishes clear operational rules across the entire lifecycle of diagnostic device licensing. It provides an exhaustive breakdown of device risk categorization—spanning low-risk Class A and low-to-moderate-risk Class B devices overseen by State Licensing Authorities, to moderate-to-high-risk Class C and high-risk Class D devices regulated directly by the Central Licensing Authority. The document specifies submission standards for test manufacturing licenses (Form MD-12), commercial manufacturing licenses, loan licensing (Forms MD-3/4 and MD-7/8), product endorsements, and license retentions. Crucially, it defines technical dossier standards for Plant Master Files (PMF), Device Master Files (DMF), Performance Evaluation Reports (PER), Essential Principles Checklists, and Quality Management System (QMS) adherence. To facilitate an inclusive regulatory rollout, the CDSCO has opened a 15-day public consultation window from the date of release, inviting industry stakeholders, testing laboratories, and medical device associations to submit structured comments and recommendations via the official portal before the final guidelines are formally adopted.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
