Medical Device Packaging

Classification of the Medical Devices

Class One

They are those medical devices of low risk, subject to general controls, not intended to protect or maintain life or for a use of special importance in the prevention of deterioration of human health and do not pose an unreasonable potential risk of disease or injury.

Class Two A

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They are medical devices of moderate risk, subject to special controls at the manufacturing stage to demonstrate their security and efficiency.

Class Two B

They are high risk medical devices, subject to special controls in design and manufacture to demonstrate their safety as well as efficacy.

Class Three

These are very high risk medical devices subject to special controls intended to protect or maintain life or to utilize the substantial significance in preventing the deterioration of health or if their use can present a possible risk of sickness or injury.

Class Four

They are high critical devices, so extreme care is needed in their manufacturing as well as usage.

Biomedical equipment is operative that brings together electrical or hydraulic systems and the computer programs which may be required in their functions.

Biomedical equipment of controlled technology has special control for the reason that it is included in the situations according to their high risk classification and the degree of vulnerability associated with these devices. These are derived from the design, manufacture, installation, handling and intended purpose and are the prototypes that lead to new scientific and technological developments.

Their acquisition, installation and use require an investment of more than 700 legal minimum wages in force and are classified as class two b and class III.

Those that are subject to supply control through the use of standards that allow the efficient distribution of technology by geographical areas in the country, according to the parameters of law correspond to the equipment used or repowered.

It is the equipment that has been used in the provision of services or in demonstration processes, in which part of its main subsystems have been replaced with new parts by the manufacturer or authorized distributor and that meet the requirements specified by the manufacturer and the safety regulations under which it was constructed.

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The repowering process must comply with the safety regulations and the requirements specified by the manufacturer. The substitution of the main subsystems of the retrofitted biomedical equipment will only be possible with elements, parts, pieces and spare parts new or repowered by the same manufacturer. Please, click here now to see more details.

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