Before registration, products must be classified according to risk level under MOHAP regulations.
01
Why Classification Matters?
Before registration, products must be classified according to risk level under MOHAP regulations.
02
Classification Overview
Class I: Low risk devices Class II: Moderate risk Class III: High risk Class IV: Very high risk / implantables Higher classes require more extensive safety and clinical documentation.
03
Key Documentation Differences
Class Documentation Depth Clinical Data
I Basic technical file Usually not required II Expanded technical file Sometimes required III Full technical dossier Required IV Extensive safety & efficacy Mandatory
