The regime of sanitary registrations, marketing permits and sanitary surveillance of Medical Devices for human use is processed before the INVIMA as a leading institution in the National Health Surveillance System and is mainly regulated by Decree 4725 of 2005 which had a subsequent modification by Decree 582 of 2017.

What is meant by medical devices?

“They are any instrument, apparatus, machine, software, biomedical equipment or other similar or related article, used alone or in combination, including its components, parts, accessories and computer programs involved in its proper application, intended by the manufacturer for use on human beings.” These medical devices can have different purposes, for example: prevention, diagnosis, disinfection, monitoring, among others. Some examples of medical devices are: bandages, pacemakers, syringes, prostheses, catheters, among others. It is important to emphasize that these instruments do not have a therapeutic purpose as medicines do.

How are medical devices classified?

According to Article 5 of Decree 4725 of 2007, “the classification of medical devices by the manufacturer is based on the potential risks related to the use and possible failure of the devices based on a combination of several criteria such as duration of contact with the body, degree of invasion and local versus systemic effect”. This standard classifies them as follows:

Class I. Low-risk medical devices, subject to general controls, not intended to protect or sustain life or for a use of special importance in the prevention of impairment of human health and which do not represent an unreasonable potential risk of illness or injury (e.g., gauze).

Class IIa. These are moderate risk medical devices, subject to special controls in the manufacturing phase to demonstrate their safety and effectiveness (e.g. hypodermic needles).

Class Ilb. These are high-risk medical devices subject to special design and manufacturing controls to demonstrate their safety and effectiveness (e.g. orthopedic implants).

Class III. Very high-risk medical devices subject to special controls, intended to protect or sustain life or for use of substantial importance in the prevention of deterioration of human health, or if their use presents a potential risk of disease or injury (e.g., pacemakers).

In turn, Article 6 of the same Decree establishes classification criteria and Article 7 establishes classification rules in order to delve deeper into the characteristics of each medical device.

What is a sanitary registration and what types of sanitary registrations are there?

“The Sanitary Registration is the public document issued by INVIMA when the user complies with the technical, scientific, sanitary and legal requirements established in Decree 4725 of 2005, which authorizes a natural or legal person to produce, market, import, export, pack, package, process, sell and/or store a medical device” Articles 16 and 17 of the aforementioned Decree establish the prior and automatic registrations, respectively, as follows:

Sanitary Registration Prior Control. Medical devices and biomedical equipment that are not of controlled technology of classes IIB and III, require sanitary registration for their production, import, export, processing, packaging, packing, storage, sale and commercialization, prior compliance with the technical-scientific and sanitary requirements.

Sanitary Registration Automatic Control. Medical devices and biomedical equipment that are not of controlled technology of classes I and IIA, require automatic sanitary registration for their production, import, export, processing, packaging, packing, storage, sale and commercialization, subject to compliance with the requirements set forth in this decree.

What are the requirements to apply for a sanitary registration?

On the official official website of INVIMA in the section on procedures and requirements to apply for a sanitary registration of medical devices, there are some general, legal and technical requirements that must be met in order to proceed with the application for registration. However, the
procedure
can be done in person at the INVIMA offices or virtually.

Prior to applying for a sanitary registration, “it is important that the interested party has Storage and Conditioning Capacity (for imported medical devices) or Technical Sanitary Conditions or Good Manufacturing Practices ( nationally manufactured medical devices)“.

The following documents must be submitted:

Consignment (Consignment slips should be pasted completely on a sheet of paper with glue or bound as a sheet. Do not staple)
Basic information forms, application or, if applicable, letter of request.
Legal information.
Technical information.

Legal requirements:

Form duly completed in physical and magnetic media ( Excel document that can be copied), endorsed by the technical director and signed by the legal representative or proxy. If the form contains attachments, these must be included in the same way.
Certificate of free sale (imported products).
Authorization from the manufacturer to the importer and/or ownership of the sanitary registration (imported products). In case of granting the ownership of the registry in such authorization, the following must be indicated.
Proof of incorporation, existence and legal representation of the importer, manufacturer and owner, as the case may be. Sanitary and legal documents proving the existence will be accepted.
Indicate the date and the number with which the Certificate of Storage Capacity (CCAA) or Medical Device Good Manufacturing Practices (GMP) and/or Certificate of Technical Sanitary Conditions was issued.

A. In case the medical device is imported for own use, certification must be attached indicating that the product will be for own use and will not be commercialized. “Own use is understood as when the medical device does not leave the domain of the Institution.”

B. For imported medical devices, it should be noted that this concept must be approved within the certificate of storage capacity (CCAA). In case of requesting a sanitary registration for a new product that is not covered by the CAAC certificate, a copy of the notification to the technical group of the Medical Devices Directorate must be submitted, indicating the new product line to be imported.

C. For manufactured medical devices, it must be taken into account that the specific line to be manufactured must be approved within the concept of good manufacturing practices for medical devices (GMP) and/or certificate of sanitary technical conditions.

Please note: All official documents of a legal nature, coming from abroad, must come with an apostille stamp or consulate stamp (which is processed in the country of origin abroad) and legalization (which is processed at the Ministry of Foreign Affairs in Colombia); additionally, they must come with the respective official translation, if in a language other than Spanish. If the legal documents are not of an official nature, a simple translation may be provided.

Technical requirements:

Application for automatic sanitary registration risk I and IIA, and new sanitary registration risk IIB and III or renewal for medical device risk I, IIA, IIB and III.

Provide the certificate of storage capacity (CCAA) or medical device good manufacturing practices (GMP) and/or certificate of sanitary technical conditions, as the case may be:

a. In case the medical device is imported for own use, certification must be attached stating that the product will be for own use and will not be commercialized. “it is understood as own use when the medical device does not leave the institution’s domain”.

b. For imported medical devices, it should be noted that this concept must be approved within the certificate of storage capacity (CCAA). in case of requesting a sanitary registration for a new product that is not covered by the CAAC certificate, a copy of the notification to the technical group of the medical devices department must be submitted, indicating the new line of products to be imported.

c. For manufactured medical devices, it must be taken into account that the specific line to be manufactured must be approved within the concept of good manufacturing practices for medical devices (GMP) and/or certificate of sanitary technical conditions.

2. Description of the medical device: the description refers only to: indications, contraindications, warnings, main components, accessories, relationship with patients; all in Spanish.

Technical studies and analytical verifications:

a. Summary of design verification and validation documents (test report during the manufacturing process)

b. Certificate of analysis of the finished product containing the specifications, indicating the values or acceptance ranges. It is required to establish that the design complies with the specific standards and technical regulations in force for them.

4. Declaration of conformity issued by the manufacturer relating compliance with international reference standards and evidencing the name of the medical device in the case that it is not evidenced in the certificate of free sale.

5. Sterilization method. The requirement is understood to be fulfilled with the statement of the method, the reference standard on which it is based and the studies carried out. In case the sterilization method of the product is carried out with ethylene oxide, studies that demonstrate the post-sterilization residue of this must be attached.

6. Description of the method of disposal or final disposition of the medical device issued by the manufacturer.

7. Shelf life:

a. This requirement is understood to be fulfilled by attaching the stability studies that allow validation of the useful life attributed to the medical device, attaching a summary of the method, verification, validation and final result.

b. For sterile medical devices coming from the factory covered in the application for sanitary registration, this requirement is understood to be fulfilled by attaching the stability studies that allow validation of the attributed shelf life, attaching a summary of the method, verification, validation and final result.

8. Original label artwork (inserts, when applicable).

a. Manufacturer’s labels shall be submitted showing at least: name of the product or reference, name and address of the manufacturer and internationally recognized safety symbols.

b. Sticker (label) of the importer indicating (name of the product, model and/or reference, name and address of the importer, Sanitary Registration number (I, IIA, IIB and III).

9. Scientific information supporting the safety of the medical device risk IIA, IIB and III. For this purpose, biological evaluation tests of the product must be attached. (cytotoxicity, system toxicity, pyrogenicity, sensitization, intracutaneous irritation or reactivity, genotoxicity, allergenicity, hemocompatibility and carcinogenicity studies). These apply to devices that are in direct contact with the patient and a summary of the studies and tests performed must be provided. In the case of sufficiently demonstrated technologies, this requirement may be met by providing scientific evidence that is indexed or published in world-renowned journals relating to the biological evaluation of the material.

Risk analysis issued by the manufacturer for class IIA, IIB and III medical devices, mentioning the risks detected during design and manufacture, causes, severity, occurrence, detectability, solutions proposed for the mitigation of each one of them.
List of standards used.
Commercial history of the medical device (imported products) that references some countries in which the biomedical equipment is sold and sanitary alerts involved with such equipment. (Issued by the product manufacturer)
Clinical studies conducted in patients on use to demonstrate safety and effectiveness. CLASS IIB, III. Published clinical studies of similar or equivalent technologies may be submitted.

Application for automatic sanitary registration risk I and IIA, marketing permit risk IIB and III or renewal for biomedical equipment of uncontrolled technology and controlled technology risk I, IIA, IIB and III:

Provide the certificate of storage capacity (CCAA) or medical device good manufacturing practices (GMP) and/or certificate of sanitary technical conditions, as the case may be:

a. In the event that the equipment is imported for own use, certification must be attached indicating that the product will be for own use and will not be commercialized. “own use is understood as when the biomedical equipment does not leave the institution’s domain”.

b. For imported biomedical equipment of controlled and uncontrolled technology, it must be taken into account that this concept must be approved within the storage capacity certificate (SCAC). In case of requesting a sanitary registration or marketing permit for a new product that is not covered by the CAAC certificate, a copy of the notification to the technical group of the medical devices department must be provided, indicating the new line of products to be imported.

c. For biomedical equipment of controlled and uncontrolled technology manufactured, it must be taken into account that the specific line to be manufactured must be approved within the concept of good manufacturing practices for medical devices (GMP) and/or certificate of sanitary technical conditions.

2. Description of the biomedical equipment. the description refers only to: indications, contraindications, warnings, main components, accessories, relationship with patients and description of operation; all in Spanish.

3. Technical studies and analytical verifications:

a. Summary of design verification and validation documents (test report during the manufacturing process).

Declaration of conformity issued by the manufacturer stating compliance with international reference standards and evidencing the name of the equipment and its models or references.

Sterilization method (for sterile medical devices or accessories coming from the factory and covered by the application for sanitary registration and/or marketing permit). The requirement is understood to be fulfilled with the statement of the method, the reference standard on which it is based and the studies carried out. In case the sterilization method of the product is carried out with ethylene oxide, studies that demonstrate the post-sterilization residue of this must be attached.

Description of the method of disposal of the equipment issued by the manufacturer.

Useful life.

a. This requirement is understood to be fulfilled by attaching the stability studies that allow validation of the useful life attributed to the equipment, attaching a summary of the method, verification, validation and final result. In the event that the useful life of the product cannot be supported, a statement issued by the manufacturer certifying the useful life of the equipment must be provided.

b. For sterile medical devices or accessories coming from the factory covered in the application for sanitary registration and/or marketing permit, this requirement is understood to be fulfilled by attaching the stability studies that allow validation of the attributed shelf life, attaching a summary of the method, verification, validation and final result.

Original label artwork (inserts, when applicable).

a. Manufacturer’s labels shall be submitted evidencing at a minimum: product name or model/reference, manufacturer’s name and address, and internationally recognized safety symbols.

b. Sticker (label) of the importer indicating (name of the product, model and/or reference, name and address of the importer, sanitary registration number (I and IIA) or marketing permit (IIB and III).

Declaration stating that it has operation and maintenance manuals in Spanish language and the delivery of the same to the user, in the case of risk I and IIA equipment.
Scientific information supporting the safety of Biomedical Equipment risk IIA, IIB and III. For which the development of electrical and electromagnetic compatibility tests (e.g. IEC standards) must be attached, according to current international standards. Biological evaluation tests must be provided (cytotoxicity, sensitization, skin irritation, among others), which only apply to equipment accessories that are in direct contact with the patient, and a summary of the studies and tests performed must be provided. In the case of sufficiently demonstrated technologies, this requirement may be met by providing scientific evidence that is indexed or published in world-renowned journals relating to the biological evaluation of the material.
Risk analysis issued by the manufacturer for class IIA, IIB and III Biomedical Equipment, mentioning the risks detected during design and manufacture, causes, severity, occurrence, detectability, solutions proposed for the mitigation of each one of them.
List of standards used.
Commercial history of the biomedical equipment (imported products) that references some countries in which the biomedical equipment is sold and sanitary alerts involved with such equipment. (Issued by the product manufacturer).
Clinical studies conducted in patients on use to demonstrate safety and effectiveness. Class IIB, III. Published clinical studies of similar or equivalent technologies may be submitted.
Certificate or proof of compliance of the equipment with international quality standards (brand and model), issued by a national or international entity, or proof of the manufacturer’s quality system for controlled technology equipment IIB and III. (Example: ISO 13785, ISO9001).
Name and location of the health service provider institution, IPS, where the equipment will be installed, or commitment to inform about it, in case it has not yet been commercialized. commitment that at the time the equipment is placed will be reported. for controlled technology equipment IIB and III.
Declaration issued by the manufacturer or by the representative in Colombia of controlled technology equipment IIB and III, stating the following:

a. That the equipment being procured is not under experimentation.

b. Indications and uses of biomedical equipment.

c. That it is capable of supplying consumables, parts, spare parts and maintenance service for at least five (5) years, or for the useful life of the equipment if less.

d. That it will provide the user with the programs and mechanisms for the training of operators and maintenance engineers or technicians.

e. That it will provide the user with the operation, installation and maintenance manuals in the language of origin and in Spanish.

When dealing with imported devices, are additional documents required?

Article 24 of Decree 4525 of 2005 states that, in order to obtain a marketing permit for manufactured and imported biomedical equipment, the following additional documents are required in addition to the documentation required to obtain sanitary registrations:

a) Certificate or evidence of compliance of the equipment with international quality standards (brand and model), issued by a national or international entity with experience and recognition. The Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA, will define the entities recognized to issue such certifications or certificates for each country of origin;

b) Name and location of the Health Service Provider Institution, IPS, where the equipment will be installed, or commitment to inform about it, in case it has not been commercialized yet.

c) Declaration issued by the manufacturer or by the representative in Colombia of the equipment, stating the following:

That the equipment to be acquired is not under experimentation. 2. Indications and uses of biomedical equipment. 3. That it is capable of supplying consumables, parts, spare parts and maintenance service for at least five (5) years, or for the useful life of the equipment if less. 4. That it will provide the user with programs and mechanisms for the training of operators and maintenance engineers or technicians. 5. That it will provide the user with the operation, installation and maintenance manuals in the language of origin and in Spanish.

Paragraph 1. In the case of imports, in replacement of the quality certificate indicated in this article, the importer may present a certificate or proof of the manufacturer’s quality system, issued by a national or international entity with experience and recognition in this field, specifying compliance with quality standards in the manufacture of biomedical equipment, accompanied by a declaration of conformity, indicating the model of the equipment to be imported and a certificate of free sale of the product.

Paragraph 2. The marketing permit issued by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA, may cover several models of equipment of the same brand and technology, as long as the technical concept so provides.

Paragraph 3. The holder of the marketing permit for biomedical equipment classified as controlled technology must prepare an annual report specifying the amount of equipment imported, manufactured and sold, the series of each piece of equipment, its geographic and institutional location and reports of serious adverse effects presented during its use and the actions taken in this regard, as well as the information required by the competent authorities in accordance with the control of this technology. The omission or inaccuracy in the provision of this information shall give rise to the penalties established in this decree. The Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA, will compile this information, as well as that related to equipment, and will forward it to the Ministry of Social Protection.

Paragraph 4. Spare parts for the maintenance and technical support of imported biomedical equipment must have a marketing permit for the biomedical equipment to be repaired, maintained or supported. Companies whose corporate purpose includes the importation of spare parts for specific biomedical equipment must report to the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA, the imports of this kind of spare parts.

Sanitary registration or automatic renewal of risk I and IIA medical devices of imported products:

According to the
official INVIMA website
For medical devices coming from reference countries (European Economic Community, United States of America, Canada, Japan, Australia, or countries where there is a mutual recognition agreement), the provisions of Decree 3275 of 2009 must be taken into account, which homologates the following documents for Risk I and IIA medical devices: technical studies and analytical verifications, sterilization method, disposal method or final disposition.

Sanitary registration or automatic renewal of risk IIB and III medical devices of imported products:

According to the official INVIMA websiteFor medical devices coming from reference countries (European Economic Community, United States of America, Canada, Japan, Australia, or countries where there is a mutual recognition agreement), the provisions of Decree 3275 of 2009 must be taken into account, which homologates the following documents for Risk IIB medical devices: Technical studies and analytical verifications, sterilization method, disposal or final disposition method and clinical studies.

What does the sanitary registration process consist of?

Article 21 of Decree 4725 of 2005 establishes the process for the prior sanitary registration process and Article 22 establishes the process for automatic sanitary registration. It is important to note that neither type of registration requires to be processed through a lawyer.

Prior sanitary registration:

a) Fill out the form to obtain the sanitary registration, which will be provided by the National Institute for Drug and Food Surveillance, INVIMA, according to the instructions attached thereto, and submit the technical and legal documentation required by this decree;

b) File the documentation with the National Institute for Drug and Food Surveillance, INVIMA, which will verify that it is complete. Otherwise, a record shall be made, in accordance with the provisions of the Contentious-Administrative Code. This procedure does not require an attorney;

c) In case it is necessary to add or clarify the information provided, the interested party shall be requested only once to provide it within the following ninety (90) days, counted from the date of the request. If the request is not submitted within this term, it will be understood that the request is withdrawn and, consequently, INVIMA will proceed to declare the withdrawal of the application for the sanitary registration, without the refund of the money corresponding to the fee.

Paragraph 1. The sanitary authority may require samples at any time or take them from the market for the pertinent technical analysis, without the presentation of such samples being a requirement for the issuance of the sanitary registration.

Paragraph 2. The INVIMA will process the applications for sanitary registrations or marketing permits for Risk IIB and III medical devices within a term of ninety (90) working days, once all the technical and legal requirements established by the regulations on the matter are met.

Automatic sanitary registration:

a) The interested party must file before the National Institute for Drug and Food Surveillance, INVIMA, the application to which the technical and legal documentation required for the issuance of the automatic sanitary registration must be attached. The Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA, will verify that the requirements are complete;

b) When all the requirements are complied with, the National Institute for Drug and Food Surveillance, INVIMA, within two (2) days following the evaluation of the documents submitted, will issue the corresponding administrative act;

c) If the documentation is incomplete at the time of receipt, the application will be rejected outright; if the petitioner insists on filing it, the provisions of articles 11 and subsequent articles of the Contentious Administrative Code will be applied.

Paragraph. In accordance with the powers of inspection, surveillance and control, the competent health authority may verify at any time the information provided for obtaining the automatic health registration, taking into account the risk of the medical device. If from the result of the verification, the sanitary authority requires additional information, it may request it to the interested party only once, who shall have a term of ninety (90) working days to provide such information. If the information is not attached within this term, it will be understood that the registration is suspended and, therefore, without effect. After three (3) months following the suspension of the sanitary registration, if the situation is not corrected, the registration will be cancelled.

What are the costs of the medical device sanitary registration process?

The Resolution 2019058384 of December 27, 2019. updates INVIMA’s fees for all types of procedures, including the sanitary registration of medical devices in terms of Taxable Value Unit (UVT) where each unit has a value of 35,607 pesos for the year 2020. The following table of fees is shown in the aforementioned resolution for the application for the sanitary registration of medical devices, as well as for its renewal:

3003	Sanitary registration or automatic renewal for medical devices and biomedical equipment that are not Class I and IIa controlled technology.	74.78/ 2,662,691 pesos approx.
3004	Sanitary registration or renewal for medical devices and biomedical equipment that are not controlled technology Class IIb and III.	84.64/ 3,013,776 pesos approx.
3005	Marketing permit for controlled technology biomedical equipment.	85.46/ 3,013,776.48 pesos approx.
Code	Concept	UVT
3007	Sanitary registration or automatic renewal for medical devices and biomedical equipment that are not Class I and IIa controlled technology. New Platform only.	65.22/2,322,288.54 pesos approx.
3008	Sanitary registration or renewal for medical devices and biomedical equipment that are not controlled technology Class IIb and III. New Platform only.	74.21/ 2,642,395.47 pesos approx.
3009	Marketing permit for controlled technology biomedical equipment. New Platform only.	74.56/ 2,654,857.92 pesos approx.

What is the validity of the sanitary registration of medical devices?

According to Article 31 of Decree 4725 of 2005, sanitary registrations and marketing permits shall be valid for ten (10) years from the date of issuance of the corresponding administrative act. The holder of such registrations or permits may request their cancellation at any time.

How is the registration renewal processed?

In accordance with Article 32 of Decree 4725 of 2005, renewals of sanitary registrations and marketing permits will be carried out following the same procedure as their issuance with regard to technical and legal evaluations. The following are the specificities that the standard establishes:

For the same, quality control analysis and evaluation of the manufacturing process may be performed, when applicable, as well as compliance with current Good Manufacturing Practices for Medical Devices (GMP). The sanitary registrations and commercialization permits referred to in this decree shall be renewed under the same number it had initially but followed by the letter R, added with the number 1, 2 and so on.

The application for renewal must be filed before the National Institute for Drug and Food Surveillance, INVIMA, three (3) months prior to the expiration of the respective sanitary registration or commercialization permit. Any application for renewal of a sanitary registration or marketing permit that is not submitted within the established term shall be processed as a new application.

Paragraph 1. If the respective sanitary registration or commercialization permit has expired without the renewal application being filed, the application is abandoned or abandoned or the application has not been filed within the term provided herein, the corresponding product may not be imported into the country, nor manufactured, as the case may be.

If there are stocks in the market, the National Institute for Drug and Food Surveillance, INVIMA, will give the interested parties a term to dispose of them, which may not exceed six (6) months. If after this term, there are products in the market, the National Institute for Drug and Food Surveillance, INVIMA, will order their confiscation in accordance with the provisions of this decree.

Paragraph 2. If the scientific information in the file has not changed and is still valid at the time of requesting the renewal, it should not be attached again, and instead, the holder shall provide a statement to that effect.

What are in vitro diagnostic reagents?

In vitro diagnostic reagents are regulated by Decree 3770 of 2004, which has defined them as:

A reagent product, calibrator, manufactured in control material, used alone or in association with others, intended by the manufacturer to be used in vitro for the study of samples from the human body, including donations of blood, organs and tissues, primarily for the purpose of providing information related to A physiological or pathological state. 2. A congenital anomaly. 3. Determination of safety and compatibility with potential recipients. 4. Supervision of therapeutic measures.

Article 3° of the same Decree states that these are classified according to the sanitary risk in: Category III (high risk), Category II (medium risk) and Category I (low risk), taking into account knowledge, training, technology, analysis and impact of the result. The standard also gives examples of types of reagents according to their classification, as follows:

Category III:

1. Used for screening for communicable diseases in donors of blood, blood components and other tissues and organs for transplantation. 2. Used to ensure immunological compatibility of blood and other tissues and organs for transplantation. 3. Used for diagnosis of life-threatening communicable diseases in the general Colombian population, including rapid tests.

Category II:

Molecular Biology. 2. Endocrinology. 3. Toxicology-Pharmacology. 4. Blood chemistry. 5. Hematology. 6. Immunology. 7. Microbiology. 8. Coproparasitology. 9. Coagulation. 10. Blood gases. 11. Uroanalysis. 12. Immunohematology tracer cells. 13. Self-diagnostic and self-control tests.

Category I:

1. Culture media. 2. Replacement components of a case. 3. Coloring materials. 4. Diluent solutions, buffers and lysing agents. 5. Washing solutions.

However, for their manufacture, storage, conditioning, import, export and commercialization, in vitro diagnostic reagents require the sanitary registration issued by INVIMA, after complying with the requirements set forth in the current sanitary regulations.

It is pertinent to clarify that this is a different product category from medical devices.

Our lawyers are experts in the process of sanitary registration before the INVIMA of medical devices and can provide you with the help and advice you require, if you want to know more about our services you can contact us through our website.

Sanitary Registration of Medical Devices in Colombia