Permission for Test License to Manufacture Diagnostic Kits and Reagents (Form MD-12, Form MD-13)

Permission for Test License to Manufacture Diagnostic Kits and Reagents (Form MD-12, Form MD-13)

 

New Diagnostic kits both notified and non-notified are required to take test license from CDSCO for import and market in India. Test license is a license issued by the authority, to a manufacturing firm stating the authority to manufacture In Vitro diagnostic kits and reagents for test and evaluation with a purpose of statement of “Not for sale or Commercial Use”. An application for the license to manufacture In Vitro diagnostic kits and reagents for the purpose of clinical investigations or test or evaluation is filed in Form MD-12 and the permission for test license is obtained in Form MD-13.

 

The test license application made under sub-rule (1) shall also be accompanied with the following documents, namely:

  • brief description of the In Vitro diagnostic kits and reagents including intended use, material of construction, design and an undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such In Vitro diagnostic kits and reagents;
  • list of equipment, instruments;
  • list of qualified personnel;
  • copy of manufacturing licence issued under these rules, if any;
  • The licensee shall maintain a record of the details of quantity of the product manufactured under test licence.
  • approval letter authorising to undertake research and development activities issued by any Government organisation, if any.

 

We assist our clients throughout the process of filing the application which enables them to obtain the license swiftly and focus their energies on manufacturing and launch.

 

The Central Licensing Authority, on being satisfied that the requirements of these rules have been complied, shall grant a test licence in Form MD-13, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application is made.

 

A licence granted remains valid unless cancelled earlier or remain in force for a period of three years from the date of its issuance.

 

 

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