Categories to determine the Medical Device Nature according to the DNM – El Salvador

By: Cindy Lazo

– In Vitro Diagnostic Agents (IVD):

May be a reagent, calibrator, control material or kit, used alone or in combination. Intended by the manufacturer to be used in vitro for the study of samples from the human body.

Examples:

1. Glucose test strips

2. Pregnancy tests

– Computer systems for medical use:

Software intended to be used for one or more medical purposes and that does not require to be part of hardware classified as a medical device to fulfill its function.

Examples:

1. Software that analyzes heart rate

2. Image archiving and communication system

– Antiseptic and disinfectant products for hospital medical use:

These are products intended for the disinfection of other medical devices and those intended for the antisepsis of the skin or mucous membranes, prior to a surgical procedure or the antisepsis of some wounds.

Examples:

1. Hydrogen peroxide
   1. Chlorhexidine solution
   1. Tincture or iodine soap

– Other medical devices.

This category includes all medical devices other than in vitro diagnostic agents, medical computer systems, antiseptics and disinfectants for hospital medical use.

Examples:

1. Thermometers
   1. Surgical masks
   1. Dental cement
   1. Bone cement, (among others).