Ministry of Health and Sports, Union of Myanmar

Food and Drug Administration, Myanmar

Quality, Safety and Protection

  
FDA Myanmar Website is officially launched at 10:26 AM September 18, 2015.

Classification

 


Classification of Medical Device 

(According to ASEAN Medical Device Directive)

Medical devices shall be classified into the following four classes, in accordance with risk classification rules. (Risk Classification Rules for Medical Devices other than IVD Devices) and (Risk Classification Rules for IVD Devices):

 

 

Class

Risk Level

A

Low Risk

B

Low-moderate Risk

C

Moderate-high Risk

D

High Risk