To strengthen medical device regulatory compliance in India, the Central Licensing Authority has upgraded the existing online application system. This introduces a new workflow for the auto-generation of Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) for licensed medical devices (Reference File No.: MEDI52/2024-eoffice).
The Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) are essential regulatory documents issued by CDSCO for medical devices in India typically needed during tender processes for India. The MSC confirms a product’s presence in the market for a specified duration, while the NCC verifies that the license holder has no criminal convictions related to product safety or compliance.
This move is part of an ongoing effort to simplify regulatory procedures and promote ease of doing business for companies involved in the medical device import process. It also ensures a faster and more transparent issuance of compliance documents necessary for CDSCO import licenses for medical devices. As a result of this update, all existing MSC and NCC applications submitted under the old workflow will now be automatically rejected by the CDSCO system.
Hence, all stakeholders, including medical device registration authorized agents and medical device import agents, are requested to re-submit fresh applications for MSC and NCC using the updated online workflow, effective from the date of this notice (09 APR 2025).