Agency
All medical devices are regulated by the Ministry of Health and Medical Education - Food & Drug Administration
Medical Device Definition
Equipment and medical supplies is any product, devices, equipment, tools and accessories,
machinery, implant, material, reactive, laboratory calibrator, software, intended by the manufacturer to be used (alone or in combination with other items for humans for the following purposes: Diagnosis, monitoring, prevention, or treatment of disease reduction; Continue life support or support; Control and contraception; Create a process sterilization or disinfection and cleaning equipment, environment and medical wastes to desirable carrying out medical, therapeutic and health; Providing information for medical purposes by laboratory methods on Human samples; Diagnosis, monitoring, treatment, relief, compensation or correction of injury or disability replacement or modification of physiological or anatomical processes. - Study, evaluation and replacement or correction of physiology or anatomic process Regulations of equipment and medical supplies, Art. 1.
Classification of Medical Device
International Classification |
Examples |
Risk Level |
Class A |
Simple surgical instruments, tongue depressor |
Low |
Class B |
Digestive catheters, infusion pumps, and powered wheelchairs |
Low-Moderate |
Class C |
Dialyzers, and orthopaedic implants |
High-Moderate |
Class D |
Coronary stents |
High |