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Medical Devices, Class A, Class D, Class C, Class X, Class - colour coding…

- - - - Class D
    - - Class C
  - - - Class C
    - - Class D
  - - - Class C
    - - Class B
  - - - Class A
  - - - Class A
  - - - Class B
- - - - Not breached dermis
        
        Class A
      - Breached dermis
        
        Healed by primary intention
        
        Class B
        
        Not healed by primary intention
        
        Class C
    - - intended
        for channeling or storing body liquids or tissues or liquids or gases for the purpose of eventual infusion, administration or introduction into a human body
        
        Class A
      - intended to be
        connected to an active medical device which is in Class B, C or D or for channeling blood or storing or channeling other body liquids or storing organs, parts of organs or body tissues
        
        Class B
      - blood bag
        that does not incorporate a medicinal product
        
        Class C
    - - intended for modifying the biological or the chemical composition of blood or other body liquids or other liquids
        intended for infusion into the body
        
        Class C
      - intended
        modification is carried out by filtration, centrifuging or any exchange of gas or of heat
        
        Class B
    - - it does not come into contact with a person or comes into contact with intact skin only
        
        Class A
  - - - Transient
        
        (1) it is intended for transient use; and
        (2) it is not intended to be connected to an active medical device; or
        (3) it is intended to be connected to a Class A medical device only.
        
        Class A
        
        (1) it is intended for use on the external surface of an eyeball; or
        (2) it is liable to be absorbed by the mucous membrane.
        
        Class B
      - Short term
        
        (1) it is intended for short term use; and (2) it is not intended to be connected to an active medical device; or
        (3) it is intended to be connected to a Class A medical device only.
        
        Class B
        
        (1) it is intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal cavity; and
        (2) it is not liable to be absorbed by the mucous membrane.
        
        Class A
      - Long term
        
        not intended to be connected to an active medical device or it is to be
        connected to a Class A medical device only.
        
        Class B
        
        (1) it is intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or
        in a nasal cavity; and (2) it is not liable to be absorbed by the mucous membrane.
        
        Class C
      - Connection to active medical devices.
        
        intended to be connected to an active medical device which is in Class B, C or D.
        
        Class B
    - - Implantable, long term
        
        intended to be placed into any tooth
        
        Class B
        
        intended,-
        (1) to be used in direct contact with the heart, the central circulatory system or the central nervous system
        (2) to be life supporting or life sustaining;
        (3) to be an active medical device;
        (4) to be wholly or mainly absorbed by the human body;
        (5) for the administration of any medicinal product; or
        (6) to be a breast implant.
        
        Class D
        
        intended to
        undergo chemical change in the body.
        
        Class D
        
        default
        
        Class C
      - Transient
        
        Reusable
        
        Class A
        
        Connected to class X
        active device
        
        Class X
        
        Supply of energy in the form of ionising radiation
        
        Class C
        
        Have biological effect or to be wholly or mainly absorbed by the human body
        
        Class C
        
        For the administration of any medicinal product by and such administration is done in a manner that is potentially hazardous
        
        Class C
        
        Used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body
        
        Class D
        
        Default
        
        Class B
      - Short term
        
        If it is intended to undergo a chemical change in the body.
        
        Class C
        
        if it is intended to be placed into any tooth
        
        Class C
        
        if it is intended for the
        administration of any medicinal product or the supply of energy in the form of ionising radiation.
        
        Class B
        
        intended to have a biological effect or to be wholly or mainly absorbed by the human body or to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body.
        
        Class D
        
        default
        
        Class B
    - - Active therapeutic medical devices for administering or exchanging energy
        
        intended for
        the administration or exchange of energy to or with a human body.
        
        Class B
        
        if the administration or exchange of energy may be done in a potentially hazardous way (such as through the emission of ionising radiation), taking into account the nature, density and site of application of the energy and the type of
        technology involved.
        
        Class C
        
        intended for the control or
        monitoring, or to be used to directly influence the performance, of a Class C active therapeutic device.
        
        Class C
      - Active diagnostic
        medical devices
        
        intended,- (1) to be used to supply energy which will be absorbed by the human body;
        (2) to be used to capture any image of the in vivo distribution of radiopharmaceuticals; or
        (3) for the direct diagnosis or monitoring of vital physiological processes.
        
        Class B
        
        intended to be used solely to illuminate a patient's body with light in the visible or near infrared
        spectrum.
        
        Class A
        
        intended
        specifically for,- (1) the monitoring of vital physiological parameters, where the nature of any variation is such that it could result in immediate danger to the patient (such as any variation in cardiac performance,
        respiration or activity of the central nervous system); or (2) diagnosing in a clinical situation where the patient is in immediate danger.
        
        Class C
        
        intended for the emission of
        ionising radiation and to be used in diagnostic or interventional radiology.
        
        Class C
        
        intended for the control or
        monitoring, or to be used to directly influence the performance, of any active diagnostic medical device
        
        Class C
        
        intended for the administration, or removal of, any medicinal product, body liquid or other substance to or from a human body.
        
        Class B
        
        administration or removal of the medicinal product, body liquid or other substance is done in a manner that is potentially
        hazardous, taking into account, (1) the nature of the medicinal product, body liquid or substance;
        (2) the part of the body concerned; and
        (3) the mode and route of the administration or removal.
        
        Class C
      - Other active medical
        devices
        
        An active medical device to which provisions of sub-paragraphs (xii) and (xiii) do not apply
        
        Class A
      - Medical devices incorporating medicinal products
        
        incorporates as an integral part a
        substance which,-
        (1) if used separately, may be considered to be a medicinal product; and
        (2) is liable to act on a human body with an action ancillary to that of the medical device.
        
        Class D
        
        incorporated substance is a medicinal product exempted from the licensing requirements of the Drugs and Cosmetics Act, 1940 (23 of
        1940) and the rules made thereunder.
        
        Class B
      - Medical devices incorporating animal or human cells,tissues or derivatives
        
        manufactured from or
        incorporates,- (1) cells, tissues or derivatives of cells or tissues, or any combination thereof, of animal or human
        origin, which are or have been rendered non-viable; or
        (2) cells, tissues or derivatives of cells or tissues, or any combination thereof, of microbial or
        recombinant origin.
        
        Class D
        
        manufactured from or
        incorporates non-viable animal tissues, or their derivatives, that come in contact with intact skin only.
        
        Class A
      - Medical devices for sterilization or disinfection
        
        intended to be used specifically
        for,-(1) the sterilization of any other medical device;
        (2) the end-point disinfection of any other medical device; or
        (3) the disinfection, cleaning, rinsing or hydration of contact lenses.
        
        Class C
        
        intended for the disinfection of any other medical
        device before the latter is sterilized or undergoes end-point disinfection: Provided, that “end-point disinfection” means the disinfection of a medical device immediately
        before its use by or on a patient.
        
        Class B
      - Medical devices for
        contraceptive use
        
        intended to be used for contraception or the prevention of the
        transmission of any sexually transmitted disease
        
        Class C
        
        implantable medical
        device or an invasive medical device intended for long term use.
        
        Class D