A CDSCO Import License is mandatory for importing medical devices, cosmetics, and pharmaceutical products into India. Issued by the Central Drugs Standard Control Organization, this license ensures that imported products meet safety, efficacy, and quality standards. The process involves filing Form 10 or Form MD-14, submitting technical dossiers, and obtaining approval from the licensing authority. Whether you are a manufacturer or importer, understanding the CDSCO requirements is crucial for smooth clearance and distribution in India. Get expert support to navigate documentation, portal filing, and regulatory approvals efficiently with a professional CDSCO license consultant.

In India, the import of medical devices, drugs, and cosmetics is strictly regulated under the Drugs and Cosmetics Act, 1940. The CDSCO Import License is a critical approval that ensures only certified and safe products enter the Indian market. Depending on the product category, applicants must apply through specific forms—Form 10 for drugs and Form MD-14 for medical devices. Along with the application, essential documents such as Free Sale Certificates, Power of Attorney, and product specifications are required. In most cases, an Authorized Indian Agent is also needed if the manufacturer is based outside India.

Delays or errors in the CDSCO application process can result in shipment holds, penalties, or rejections at customs. Therefore, it's essential to understand the latest regulatory guidelines, especially those related to risk-classification for medical devices and the Notified List published by CDSCO. Partnering with a regulatory consultant can simplify the complex filing process, ensure accurate submissions, and speed up the licensing timeline — helping your business go to market faster with full compliance