Supporting medical device organisations with classification, manufacturing, import and test licences, sale/distribution regulatory requirements and post-approval changes under India’s regulatory framework.
Whether you are manufacturing medical devices in India, importing products, preparing devices for testing or managing an existing approval, DnA provides structured CDSCO regulatory support. The focus is on identifying the applicable requirements, preparing documentation and supporting regulatory activities at different stages of the device lifecycle.
Determining applicable medical device classification and regulatory requirements
Preparing for manufacturing, import or test licence applications
Addressing Sale/Distribution Regulatory Requirements
Managing applicable Post-Approval Changes
Support documentation and regulatory activities for Manufacturing Licences and Import Licences based on applicable device and organisational requirements.
Assist with Test Licences and device Classification to establish the appropriate regulatory pathway and documentation requirements.
Support Sale/Distribution Regulatory Requirements and applicable Post-Approval Changes as regulatory needs continue beyond initial licensing.
CDSCO compliance extends beyond obtaining an initial licence. DnA Regulatory Solutions helps organisations address requirements across classification, application preparation and ongoing regulatory activities, keeping documentation aligned as products and approved information change.
Manufacturing Licences, Import Licences and Test Licences
Classification and Sale/Distribution Regulatory Requirements
Post-Approval Changes and supporting regulatory documentation
Support Across the Regulatory Pathway:
From determining device classification to managing licence requirements and Post-Approval Changes, DnA helps organisations maintain a structured approach to CDSCO regulatory activities.
DnA supports Manufacturing Licences, Import Licences, Test Licences, Classification, Sale/Distribution Regulatory Requirements and Post-Approval Changes.
Yes. Classification can be addressed as part of determining the applicable CDSCO regulatory pathway and the documentation required for subsequent activities.
Yes. The service includes support for applicable Post-Approval Changes and related regulatory documentation as approved device or organisational information evolves.
Address classification, licensing, sale/distribution requirements and post-approval regulatory activities through a clearer, organised approach.