MD-06 Loan License for Class A & B Devices

If your company intends to manufacture low-risk (Class A) or low-moderate risk (Class B) medical devices but does not own a manufacturing plant, you can apply for an MD-06 Loan License. This allows you to contract the manufacturing to a third-party host site that already holds a valid CDSCO manufacturing license (MD-05). We draft the contracts, check the host QMS, and file the loan applications.

Key Benefits

  • No heavy capital expenditure on setting up a factory
  • Leverages existing certified infrastructure and equipment
  • Full ownership of brand and formulation

Recognized Standards

CDSCO
BIS
ISI

Our Methodology

1

Document Collection

Collection of documents from the client for creation of the CDSCO account.

2

CDSCO Account Setup

Creation and activation of the CDSCO online account.

3

Loan License Documents

Collection and review of documents required for the Loan Licence application.

4

Technical Documentation

Preparation of technical documentation including Device Master File (DMF) and Site Master File (SMF).

5

Draft Form MD-04

Preparation and verification of Draft MD-04 application form.

6

CDSCO Submission

Submission of application through the CDSCO portal.

7

Application Review

Review and scrutiny of the application by the State Licensing Authority and closure of regulatory observations/comments, if any.

8

License Granted

Grant of Loan Licence in Form MD-06 by the State Licensing Authority.

Required Documents

Consent Letter from host manufacturer
Manufacturing Agreement copy
Master files of the device to be manufactured
Host site valid manufacturing license

Common Questions

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