CDSCO Medical Device Registration in India

CDSCO Medical Device Registration & Compliance

CDSCO (Central Drugs Standard Control Organisation) is India's national regulatory authority for drugs and medical devices under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.

Medical devices placed on the Indian market are regulated under the Medical Devices Rules, 2017 (MDR 2017), along with applicable provisions of the Drugs and Cosmetics Act, 1940 and related regulatory requirements.

Medical devices are classified according to their associated risk, and the applicable regulatory pathway depends on the device classification, intended use, manufacturer/importer status and applicable Indian requirements.

Key CDSCO Medical Device Compliance Areas

• Medical device classification
• Identification of applicable Indian regulatory requirements
• Manufacturer and importer regulatory requirements
• Medical device registration and licensing, as applicable
• Import licence requirements, where applicable
• Manufacturing licence requirements, where applicable
• Technical documentation and product information
• Quality Management System requirements
• Labelling requirements
• Clinical investigation and performance evaluation, where applicable
• Post-market surveillance
• Adverse event and safety reporting
• Device traceability and applicable records
• Compliance with applicable Indian Standards and regulatory requirements

CDSCO Compliance Support

OMCS provides CDSCO medical device regulatory consultancy and compliance support to manufacturers, importers and organisations seeking to place applicable medical devices on the Indian market.

Our support may include device classification, regulatory pathway assessment, documentation support, licensing and registration guidance, QMS support, labelling review, technical documentation and regulatory compliance preparation based on the applicable product and regulatory requirements.

Note: CDSCO requirements vary according to the type and classification of medical device and the applicant's role in the supply chain. Regulatory requirements should therefore be assessed on a product-specific basis.