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CDSCO / Medical Device Approval

Obtain CDSCO registration and import / manufacturing licences for medical devices and notified products.

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Overview of CDSCO / Medical Device Approval

The Central Drugs Standard Control Organisation (CDSCO) regulates the import, manufacture and sale of medical devices and certain notified products in India. Depending on the device risk class, an import licence (MD-15) or manufacturing licence may be required.

We classify your device, prepare the technical dossier and manage the CDSCO application end to end.

Key Benefits of CDSCO / Medical Device Approval

Regulatory compliance: Approval under the Medical Device Rules
Correct classification: Device risk class assessed accurately
Import / manufacture ready: Right licence obtained
Dossier support: Technical documentation prepared
Expert liaison: Coordination with CDSCO

Documents Required

Device details, classification and intended use
Manufacturing / free-sale certificate (for imports)
ISO 13485 and quality certificates
Device master file and plant master file
Authorisation and constitution documents

How It Works — Our Process

Classify the device and identify the licence required
Compile the technical dossier
File the application on the SUGAM portal
Respond to CDSCO queries
Receive the registration / licence

Need help getting started? Our experts at Atcorpcare handle the end-to-end process for you. Fill in the enquiry form and a specialist will get in touch.