Medical Device License

CDSCO Compliance for Manufacturing and Import

Licensing under the Medical Device Rules, 2017

Medical devices are regulated in India under the **Drugs and Cosmetics Act, 1940**, and the dedicated **Medical Device Rules, 2017**. Licensing is mandatory for all classes of devices (Class A, B, C, D) based on risk.

Licenses are issued by **CDSCO (Central Drugs Standard Control Organisation)** or State Licensing Authorities. Compliance requires strict adherence to **Quality Management System (QMS)** norms, often based on ISO 13485 standards.

Key Compliance Steps

  • **Mandatory:** MD-4 (Import) or MD-7 (Manufacturing)
  • **Requirement:** Compliance with ISO 13485 QMS standards.
  • **Personnel:** Qualified technical staff appointment required.
  • **Governing Body:** Central Drugs Standard Control Organisation (CDSCO).

Medical Device Licensing Advisory

We provide specialized technical and regulatory support for CDSCO licensing and QMS adherence:

CDSCO Licensing Plan

₹45,999 + Govt. Fees*
  • ✔ Classification of Device (A, B, C, or D)
  • ✔ QMS Documentation Support (ISO 13485)
  • ✔ Technical File & Site Master File (SMF) Vetting
  • ✔ Online Filing of Forms (MD-7 or MD-4)
  • ✔ Support for Physical Inspection by Authorities
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