Class A and B Medical Device Manufacturing
Registration in India – MD13

MD-13 is a license granted by the Central Licensing Authority (CLA) under India’s Medical Device Rules, 2017. It allows manufacturers to produce medical devices in limited quantities specifically for testing, evaluation, demonstration, or training purposes — and not for sale or commercial use.
This permission plays a vital role in the early stages of product development, especially when manufacturers need to:
● Conduct testing or analytical validation
● Perform performance evaluations or functional assessments
● Demonstrate the device to regulatory bodies, investors, or healthcare professionals MD-13 is applicable to all four classes of medical devices — Class A (low risk), Class B (low–moderate risk), Class C (moderate–high risk), and Class D (high risk), making it a universal requirement for test-stage manufacturing activities. In summary, the MD-13 license allows Indian manufacturers to produce medical devices in limited quantities for non-commercial purposes such as testing, evaluation, demonstration, or training. It serves as an approval process that allows manufacturers to carry out testing, evaluation, demonstration, or training before applying for full manufacturing or marketing authorization.