Import Licences for Medical Devices
CDSCO import licences for foreign-manufactured medical devices distributed in India. Filed by Indian importers or Authorised Indian Agents. Requires a valid Free-Sale Certificate from the country of origin, an India-based AIA with a registered office, and product registration evidence. Granted per product family and remains valid until suspended, with variations and re-export records reviewed periodically.
2 CDSCO forms in this category
Application for Issue of Import Licence for Medical Devices
Application for an import license for medical devices.
Licence to Import Medical Devices
License granted to import medical devices.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
Indian entity required
Application must be filed by an Indian entity — your subsidiary or an Authorised Indian Agent (AIA).
Foreign manufacturer documentation
Manufacturing licence from country of origin, ISO 13485 certification, free-sale certificate.
Device classification
CDSCO classification confirmed (A/B/C/D); influences review depth and fees.
Documentation checklist
- Power of Attorney / AIA agreement
- Foreign manufacturing licence (notarised)
- ISO 13485 certificate from foreign manufacturer
- Free Sale Certificate from country of origin
- Device master file
- Labelling and Indian-language IFU
- Test reports per Indian standards (or equivalence justification)
- Application fee
Step by step
- 01
AIA / importer setup
Establish Indian entity to hold licence, sign POA / AIA agreement.
- 02
MD-14 filing via SUGAM
Application with full dossier submitted to CDSCO.
- 03
Technical review
CDSCO evaluates manufacturer credentials and device file.
- 04
Query handling
Clarifications on labelling, IFU, or test reports addressed.
- 05
Licence issuance (MD-15)
Import licence granted, typically valid in perpetuity with annual self-declarations.
- 06
Customs and import operations
Licence enables clearing imported devices through customs into India.
Common questions
No. The application must be filed by an Indian entity. Use your Indian subsidiary or engage an Authorised Indian Agent.
8–14 weeks for typical Class B/C devices. Class A is faster; Class D may require additional clinical evaluation.
MD-15 licences are perpetual subject to annual self-declarations and post-market vigilance compliance.
Yes — devices from the same manufacturer can be grouped on a single licence with appropriate fee structure.
IFU and labelling must comply with Legal Metrology Rules including required regional-language declarations.
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