Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

What is the Medical Device Classification?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Neha_Mate, Jan 14, 2019 at 9:00 AM.

  1. Neha_Mate

    Neha_Mate New Member

    Joined:
    Monday
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    Hello I am new in medical device manufacturing and wanted to know more about medical device classification in different countries.
     
  2. Operon_Strategist

    Operon_Strategist New Member

    Joined:
    Aug 17, 2018
    Messages:
    3
    Likes Received:
    1
    Trophy Points:
    2
    Medical Device Classification is based on different regulatory bodies as per different countries.

    This classification helps you to go for the medical device registration and market your device in different countries.

    MEDICAL DEVICE REGISTRATION IN INDIA

    CDSCO Regulatory Bodies Are Responsible For Medical Device Registration In India.

    Classification Of Medical Device In India:

    Class A: Low Risk (Example: Thermometers And Tongue Depressors)

    Class B: Moderate-Risk (Example: Hypodermic Needles, Suction Equipment)

    Class C: Moderate-To High-Risk (Example: Lung ventilator, Bone fixation)

    Class D: High-Risk (Example: Heart valves, Implantable devices)

    MEDICAL DEVICE REGISTRATION IN SAUDI ARABIA

    The national regulatory authority agencies responsible for healthcare in Saudi Arabia are the Ministry of Health (MoH) & Saudi Food & Drug Authority (SFDA).

    Classification Of Medical Device In Saudi Arabia:

    Class I: Low Risk (Example: Stethoscope, Breath-Alcohol Test System)

    Class II, IIa, IIb: Medium Risk (Example: Protein Test Systems, Syringes)

    Class III, IV: High-Risk (Example: External/Internal Pacemakers, Plasma Warming Device)

    MEDICAL DEVICE REGISTRATION IN Australia:


    The national regulatory authority agencies responsible for healthcare in Australia is the Therapeutic Goods Administration (TGA)

    Classification Of Medical Device In Australia:


    Class A: Low Risk

    Class B: Low Moderate-Risk

    Class C: Moderate-High Risk

    Class D: High-Risk (Where risk Identifies to The patients or to public health)
     

Share This Page