Medical Equipments Reviews

According to the recommendations of the Global Harmonization Task Force (2005), MEDICAL EQUIPMENT means:

Any instrument, apparatus, implement, machine, implant, in vitro reagent or calibrator, software, material or other similar or related article:

Intended by the manufacturer for use in humans, alone or in combination, to one or more specific purposes:

• diagnosis, prevention, control and treatment or alleviation of disease;
• diagnosis, monitoring, treatment and relief or compensation for an injury;
• investigation, replacement, modification and support of the anatomy or a physiological process;
• support or preservation of life;
• control of conception;
• disinfection of medical equipment;
• providing information for medical / diagnostic purposes through in vitro examination of specimens obtained from the human body.
• Fails to fulfill the main function for which it is intended in the human body by pharmacological, immunological or metabolic, but may be assisted by such means.

Note 1: The definition of a team for in vitro diagnosis includes, for example, reagents, calibrators, sample collection and storage equipment, control materials, implements or related equipment. The information provided by this in vitro diagnostic kits can be for diagnostic purposes, monitoring or compatibility. These in vitro diagnostic kits, including reagents and the like, will be reviewed by the relevant competent authority in each country.

Note 2: The products can be considered as medical equipment, as set by each country, for which there is still no harmonized approach are:

• Means for the disabled or physically handicapped.
• Devices for the diagnosis and treatment of diseases and injuries in animals.
• Accessories for medical devices (see note 3).
• Chemicals for disinfection.
• Devices incorporating animal and human tissues, which can meet the requirements defined, but are subject to different controls.

Note 3: Accessories intended specifically by manufacturers to be used in conjunction with a medical team “father”, to allow the medical team to fulfill the purpose for which it is intended, should be subject to the same procedures of the GHTF, which apply to own medical team. That is, an accessory may be classified as if it were a medical team. This may result in the accessory having a classification other than the medical team “father.”

Note 4: The components of medical devices are generally controlled by the control system manufacturer’s quality and conformity assessment procedures for the team. There are countries that include the components in the definition of medical equipment.