The Central Drugs Standard Control Organization (CDSCO) has issued draft guidelines for Medical Device Software, marking a significant step toward aligning India’s regulatory landscape with international best practices. The initiative aims to offer manufacturers and importers clearer direction on compliance and quality expectations within the country.
According to the Drugs Controller General of India (DCGI), the draft has been developed to harmonize India’s regulatory requirements with globally accepted standards. The 76-page document comprehensively outlines the scope, definitions, classification, and applicable standards for medical device software. It also specifies requirements related to technical documentation, quality management systems, and licensing authorities.
The new draft provides detailed regulatory guidance for a wide range of medical device software, including those used for clinical investigations and performance evaluations. Notably, it incorporates provisions specific to software used in in vitro diagnostics (IVDs).
Manufacturers are advised to carefully assess the document’s technical and quality requirements to ensure compliance.
Under the existing Medical Devices Rules, 2017, regulatory provisions already cover both Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD) — addressing safety, performance, and quality parameters. These standards guide applicants through the processes of manufacturing, marketing, and distribution licensing across India.
By issuing these updated draft guidelines, CDSCO underscores its commitment to strengthening digital health regulation and fostering an environment that supports safe, innovative, and globally competitive MedTech software emerging from India.
Also Read