The manufacturing and usage of the medical devices are very sensitive matters and the health department always very active regarding the rules and regulations, so that there is no chance of malpractice by medical professionals and there are no harms to the patients. Keeping it in view, the concerned authorities have classified the medical devices in four different categories based on their level of risk in usage.
The objective of the classification of medical devices is to exercise different controls for each of them, tending to minimize the risks of producing disease or damage and provide protection and worth to the users.
The classification and explanation rules are available in the book of regulatory framework for medical devices provided by the manufacturers and the institute where the medical devices are being used with the general rules of classification with practical aspects and examples. Here are some examples of classified medical devices.
- Class I includes bandages, clinical beds, bottles for collecting urine, stethoscopes, among others.
- Class II includes the surgical gloves, removable dentures, contact lenses, among others.
- Class III includes condoms, infusion pumps, anesthesia machines, dialysis equipment, radiotherapy equipment, among others.
- Class IV includes heart valves, intrauterine devices, implants, among others.
The medical devices are available as new items while they are also repowered which lowers the cost for the buyers. The repowered medical devices has the same characteristics of effectiveness, safety and performance of the new ones. The repowered medical devices are in optimal state of the operation, which should include its safety systems.
The holder of the sanitary registration or marketing authorization of the repowered medical devices has the sanitary registration or the marketing authorization of new equipment of equal characteristics. The importer has the authorization of the manufacturer or its representative in the country to import the equipment that has been repowered. The equipment that emits ionizing radiation must have an authorization issued by the competent authority in the matter, for the management of this class of equipment.
Quality in the manufacturing processes of national medical devices is of prime importance along with the quality of service of maintenance of the medical devices. Post-market techno vigilance in order to identify and locate adverse incidents associated with the use of medical devices is practiced to ensure the maximum usefulness and the avoidance of any hazards.
The packaging of medical devices is another major concerns as many devices are very sensitive and are made of glass.
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
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.
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.
