Medical Devices Registration

Class A and Class B medical devices (lower risk categories such as basic diagnostic tools and consumables) go through a registration process on the CDSCO/SUGAM portal rather than a full import or manufacturing licence, streamlining market entry for lower-risk products.

This lighter registration route exists because lower-risk devices don't warrant the same regulatory intensity as implants or life-support equipment — registration still creates an accountable, traceable record on the national system, but without the fuller clinical review reserved for higher-risk classes.

Class A covers the lowest-risk devices (such as basic surgical instruments and simple consumables) and Class B covers moderate-low risk devices (such as many diagnostic and hospital-supply items) — both file through registration rather than the import/manufacturing licence route required for Class C and D. The distinction between A and B still matters for documentation depth, so confirming the exact sub-class before filing avoids submitting an incomplete file.

Because registration is comparatively fast, it's a common entry point for companies bringing their first device into India before later expanding into higher-risk categories — the manufacturer credentials and quality documentation built up during a Class A/B registration often carry forward usefully if the company later files for a Class C/D product.