Draft Guidance document for Manufacturers of In-vitro diagnostic Medical device for stakeholders comment

The guidance provides manufacturers with a structured approach to preparing and submitting applications for manufacturing licenses for IVD) medical devices under the Medical Devices Rules, 2017. It explains the different types of manufacturing licenses and their respective issuing authorities, the online portals for application submission, the risk classification of IVD' s, the legal provisions and application requirements, the applicable fees under the MDR, 2017, inspection requirements, application pathways for testing, fresh license applications, product endorsements, and license retention, as well as the prescribed timelines for different types of applications.   The document also provides checklists for manufacturing test licenses and manufacturing licenses across the applicable IVD risk classes. Additionally, it outlines expectations for technical and regulatory documentation, including intended use, performance evaluation, risk management, quality management systems, plant and device master files, stability information, and labeling.   CDSCO has invited stakeholders to submit comments and suggestions within 15 days of publication. As the document remains a draft, manufacturers should refer to the finalized guidance, once issued, and the applicable regulatory provisions before implementing changes to their compliance processes.