Test Licence to Manufacture (Form MD-13) is granted by CDSCO under the Medical Devices Rules, 2017 for manufacturing medical devices in limited quantities for testing, evaluation, clinical investigation, demonstration, or training purposes. The application is submitted through Form MD-12. This licence allows manufacturers to legally produce prototype or test devices before commercial approval while complying with applicable CDSCO requirements. MD-13 is commonly used during product development, performance evaluation, validation studies, and non-commercial testing activities.
Challenge
A startup medical device company wanted to
manufacture a prototype device for clinical evaluation and internal testing but lacked clarity on
regulatory approval requirements. They were unsure about documentation, labeling restrictions, and how to
proceed with CDSCO for an MD-13 Test License.
Our Approach
Outcome
FAQ
An MD-13 Test Licence issued under the Medical Devices Rules, 2017 is generally valid for three years from the date of issue unless suspended or cancelled by the licensing authority.
Yes. Applicants may include multiple testing or evaluation sites within a single application, subject to appropriate justification and quantity details for each location.
Manufacturers conducting prototype development, verification, validation, performance evaluation, or non-commercial testing activities may require an MD-13 Test Licence under MDR 2017, depending on the intended use and testing scope.
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