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Medical Devices Clinical trial

According to the National Ethical Guidelines, "a medical device is a medical tool which does not achieve its primary intended action in or on the human body by pharmacological, immune, or metabolic means but which may be assisted in its intended function by such means."

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SERVICES

It may be an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or an accessory, and it could have been made specifically with humans or animals in mind for one or more of the following purposes:

  1. Detection, diagnosis, prevention, monitoring.

  2. Point of care testing (POCT).

  3. Treatment or alleviation of any physiological condition or state of health, or illness;

  4. Replacement or modification or support of the anatomy or congenital deformity;

  5. Supporting or sustaining life;

  6. Disinfection of medical devices; or

  7. Control of conception.

  8. Medical & Surgical Dressings.

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