How Much Do Medical Devices Cost?
The cost of medical devices can range from, R1000 – R20,000+.
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*R 1190.24 p/m
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In general terms, medical device is any physical entity, including apparatus, hardware, software, physical device or material, which supports humans to deal with medical circumstances.
World health organization has given a broad definition focusing on its purpose:
‘Medical device’ means any instrument, apparatus, machine or appliance for in vitro use, hardware, software, material or other related article or the combination of it used for the specific medical purposes including
- diagnosis, monitoring, prevention, treatment or alleviation of disease or an injury,
- investigation, modification, replacement, or support for a physiological process,
- supporting or sustaining life,
- disinfection of medical devices
- Providing information by means of in vitro examination derived from the human body.
Medical devices are categorized based on risk associated with usage of the device. The categorization is based on the following parameters:
- The general regulatory controls
- The special regulatory controls
- The need of premarket approval (PMA)
What are general controls for medical devices?
General controls are fundamental provisions to ensure the safety and effectiveness of regulatory devices. It includes provision for adulteration, misbranding, device registration, notifications for repair/replacement or refund, premarket notification, records & reports, and good manufacturing practices.
What are special controls for medical devices?
Special controls are additional controls to general controls for reasonable safety and usability assurance, which includes specific labeling such as usage methods, guidelines, recommendation etc.; performance standards; post-market monitoring; patient registration and more.