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parameters for classification medical devices (In vitro diagnostic MD…

- - - - MD for contraceptive use
        
        class D (clause A) implantable medical device or an invasive MD for long term use
        
        class C (clause B) contraception or prevention of the transmission of any sexual transmitted diseases
      - MD for sterilization or disinfection
        
        class B disinfection of any other medical devices before the latter is sterilized or undergoes end-point disinfection
        
        class C (clause B) sterilization of any other MD, end-point disinfection of any MD, disinfection, cleaning rinsing or hydration of contact lenses
      - MD incorporating animals or human cells, tissues or derivatives
        
        class A (clause A) manufactured from or incorporates non-viable animal tissues or their derivatives, that come in contact with intact skin only
        
        class D (clause B) cells, tissues or derivatives of cells or tissues or any combination thereof of animal or human origin or microbial or recombinant origin
      - MD incorporating MP
        
        class B (clause A) if its a medicinal product exempted from licensing requirement of the drug and cosmetic act, 140(23 of 1940)
        
        class D (subject to clause B) considered as MP if used seperately
      - class A AMD to which provisions of (sub paragraphs xii & xii)
    - - class C control or monitoring, or to be directly influence the performance, of a class
      - class C (clause A) administration or exchange of energy may be done in potentially hazardous way such as through the emission of ionizing radiation, taking into account the nature, density and site if application of the energy and the type of technology involved
      - class B (subject to clause B) administration or exchange of energy to or with a human body
    - - class C (clause F) administration or removal of the medicinal product, body liquid or other substances is done in a manner that is potentially hazardous, taking into account
      - class B (clause G) administration or removal of any medicinal product, body liquid or other substance to or from a human body
      - class C (clause D) control or monitoring or to be used to directly influence the performance
      - class C emission of ionizing radiation and to be used in diagnostic or interventional radiology
      - class c (clause A) monitoring of vital physiological parameters or diagnosing in a clinical situation where the patient is in immediate danger
      - class A (sub clause 1 of clause A) used solely to illuminate a patient's body with light in the visible or near infrared spectrum
      - class B (clause B &C) used to supply energy which will be absorbed by the human, capture any image of the in vivo distribution of radio pharmaceuticals, direct diagnosis or monitoring of vital physiological processes
  - - - class D undergo chemical change inhuman body
      - class D direct contact with heart, the central nervous system, central circulatory system, life supporting or life sustaining, to be an active MD, wholly or absorbed by the human body, administration of any medicinal product, breast implant
      - class B intended to be placed into any tooth
      - class C (subject to clause B, C, D)- implantable MD or a surgically invasive MD
    - - class A (subject to clause A)- intended to 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, is not liable to be absorbed by the mucous membrane
      - class B (subjected to clause B)- not intended to connect to active MD or only in class A
    - - class B (subjected to clause A)- intended for use om the external surface of an eyeball, is liable to be absorbed by the mucous membrane
      - class A (subject to clause B)- transient use, not intended to be connected to active MD, intended to connect with class A MD