DEVICE CLASSIFICATION AND DEVICE GROUPING

In Colombia, the Ministry of Health (MoH) is the entity in charge of developing the laws and regulations for medical devices or EMB (Equipment and Biomedical Material) –both terms are considered synonymous in this document and used interchangeably. The classification of such devices or EMBs is designated based on the level of risk and results in 4 classifications (class I, II, III and IV) based on Chapter II of the Official Decree 34482-S. In this guideline, we will summarize the referred regulation to correctly classify and group a medical device in Colombia.

Non-medical devices and unregulated devices

As mentioned, the decree No. 34482-S details the classification rules. In the Annex 1 of this document, 62 class I listed devices are exempted from a regulatory process, including the registration. As we will further explain, after the publication of these 62 unregulated products, the Ministry of Health stated that if a medical device is considered as class I, a sanitary registration is not required, even if it is not mentioned in Annex 1. However, a proper classification is a very important aspect to ensure that it belongs to this category. Otherwise, a product that requires a sanitary registration may end up illegally commercializing in the country.

Medical Devices

We have mentioned a list of 62 unregulated devices and that any class I medical device is also exempted of a sanitary registration. Nevertheless, it is important to have a better idea of each medical device class description to identify which products are unregulated (class I or a non-medical device) or regulated (class II, III or IV).

Class I EMB

Non-invasive EMB in direct contact with wounded mucosa or skin.
Invasive EMB that enter into the body through a natural orifice.
Invasive but not surgical EMB, not connected to active medical equipment (those related with a power source).
Surgical or dental reusable instrument.

Wound dressings, nasal or oropharyngeal cannulas and reusable instruments used by surgeons are typical examples of this class.

Class I devices are no longer registered per regulation N° 41387-S issued on November 26, 2018.

Class II EMB

Invasive EMB that enter into the body through a natural orifice.
Any EMB intended to be in direct contact with the eye surface.
Non-invasive EMB destined to contain or to lead gases, liquids or corporal fluids to be introduced to the body.
Non-invasive EMB designed to modify the blood biological and/or chemical composition.
Surgically invasive EMB.
Non-invasive EMB connected to an active medical device (those related with a power source).
An active EMB used to clean and sterilize another device.
Active EMB intended for diagnostic or monitoring procedures.
Personal use IVD (In Vitro Diagnostic) tests to detect pregnancy, fertility, glucose or cholesterol levels
Sponge-type contraceptive devices, diaphragms and their insertion devices.

Some common medical devices located in Class II are: eye contact lenses, probes for endoscopy, ultrasound systems, hypodermic needles and pregnancy tests.

Class III EMB

Invasive and surgical EMB that will remain inside the body for a period of 30 days or more.
Non-latex or non-natural membrane condoms.
Intrauterine devices and their insertion devices used in contraception.
Active EMB (those related to a power source) intended to evaluate a disease and from which an error in the result may cause immediate threat to the patient’s health.
Active EMB used in therapy to deliver or exchange energy to the patient’s body.
IVD (In Vitro Diagnostic) equipment, which is used for tests whose erroneous result can cause death or severe damage.
Active EMB used to emit ionizing radiation.

Surgical sutures, orthopedic implants and X-ray equipment are a good example of Class III EMB.

Class IV EMB

Natural membrane condoms.
Invasive and surgical EMB used to diagnose, monitor, control, or correct a defect of the central cardiovascular system or the central nervous system.
EMBs used to disinfect or sterilize organs to be transplanted.
EMB (except for IVDs) that incorporate in their manufacture an animal source, or products obtained through the use of recombinant DNA technology.
Breast prostheses and tissue extenders for breast prostheses.
IVDs to detect the presence of sexually transmitted agents: HIV, HLTCV, HBV, HCV and HDV.

Cardiac bypass and cerebrospinal valves are examples of class IV EMB.

DEVICE GROUPING

Once the classification is defined, another crucial topic to consider is the grouping. Appropriate grouping criteria will allow us to group multiple devices in a single application. Nevertheless, there are certain concepts that are worth knowing to properly group a medical device. Specifically:

EMB family: Set of EMB’s that have been made by the same manufacturer, have the same design and manufacturing process, are used for the same purpose and only differ in shape, color, taste, or size.
EMB group: It comprises a collection of EMBs that are presented for commercialization together to be used in a specific procedure. Its components may differ from each other and can be made by different manufacturers.
EMB group family: This is a collection of EMB groups that are made by the same manufacturer, have the same generic name, specific use, and differ only in the number and combination of products that each group contains.
Test kit: consists of reagents or items, or some combination of these, that will be used together to perform a specific test. This does not include the instruments necessary to carry out the test. The components of a kit are subject to the same registration, although these can be sold separately as a replacement for the mentioned kit.
Test kit family: This is a collection of test kits that are made by the same manufacturer, have the same generic name, specific use, and belong to the same diagnostic area.

The Ministry will grant a single registration to each EMB family, EMB group, EMB group family, test kit family or test kits. In addition, the Ministry of Health will assign a unique registration number to the group but an alphanumeric code to identify each member of the group.
If it is desired to include or change another member of the family or component of the system, a modification request must be submitted to the Ministry of Health through an official application signed by the responsible registrant.
As expected, and in all cases, a single registration will involve a single payment.