India’s Central Drugs Standard Control Organisation (CDSCO) has rolled out an upgraded, automated system for issuing Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC) for medical devices. As a result, all manufacturers and importers must now re-submit their applications through the new system.
In a recent public notice, CDSCO’s Medical Device Division announced that the new auto-generated certification workflow is designed to streamline the regulatory process. The upgrade replaces the existing online application procedure for MSC and NCC certificates.
The notice clarified that all applications submitted under the previous system will now be automatically rejected. Stakeholders are required to file fresh applications starting April 9, 2025.
The Non-Conviction Certificate (NCC) confirms that a company—whether a domestic manufacturer or an importer—has not been convicted for any safety or quality violations related to medical devices. This certificate demonstrates regulatory integrity and compliance.
The Market Standing Certificate (MSC) is used to verify a company’s adherence to regulatory standards and is often needed for exporting medical devices or participating in government tenders.
As per CDSCO’s earlier guidance, only companies that hold valid licenses for manufacturing or importing medical devices in India are eligible to apply for these certificates.
This shift to an automated process is part of CDSCO’s broader effort to enhance efficiency and transparency in regulatory approvals for the medical device industry.
