In Colombia, there is a significant regulatory framework for medical devices and healthcare products. Each product category has its own set of standards with which to comply in order to be considered safe for the consumer.
Thus, for medical devices, Decree 4725 of 2005 regulates the marketing authorisation regime for products and health surveillance.
Decree 677 of 1995 establishes the entire regulatory framework for pharmaceuticals, including the evaluations with which all pharmaceuticals drugs must comply to be considered safe and effective in order to be marketed in the country.
Concerning blood products, these are given the same treatment as biological drugs, and their safety and effectiveness evaluation requirements are contained in Decree 1782 of 2014.
Finally, as regards personal protective equipment and medical instruments, under Colombian healthcare regulations, these are also considered medical devices, and the same provisions for medical devices mentioned above apply to these products.
Medical devices are also subject to the general recall provisions set forth in the Consumer Protection Statute. If the medical device has a design or manufacturing defect that threatens the life or health of patients, the general recall provisions are applicable and the Superintendence of Industry and Commerce, as the Colombian consumer protection agency, must be informed about the recall and the measures adopted to withdraw the product from the market or repair any units already marketed.
Accordingly, anyone involved in the commercialisation chain of a product has a duty to report any defect that may threaten the safety of consumers, within three days of learning about the problem. Alongside the report of the issue, a plan to address the safety concerns must be filed before the Superintendence of Industry and Commerce. The filing must be made through the product safety website administered by the Superintendence and should include:
Regarding cosmetics, in Colombia, they are regulated by the provisions of the Andean Community (a free trade area comprising Bolivia, Colombia, Ecuador, and Peru), particularly in Decision 833 of 2018. It is pertinent that cosmetics are not considered health products in Colombia, and they cannot make therapeutic claims.
There is no legal definition of biocides in Colombian law. They are regulated according to the use of the product. Thus, biocides for medical devices are regulated by Decree 4725 of 2005. Moreover, if a biocide is intended for household utensils, objects, or surfaces, it will be considered a household hygiene product, and Decision 706 of 2008 contains the relevant provision. Finally, biocides with antibacterial agents for human skin are governed by the same provisions applicable to cosmetics.
For food, Resolution 2674 of 2013 sets out the general sanitary requirements to manufacture, prepare, bottle, transport, distribute and market food in the country. Accordingly, all food directed to the consumer must be authorised to be sold by the National Institute for Drug and Food Surveillance (INVIMA).
Furthermore, in Colombia, each type of food has its own regulation and standards to follow. In that sense, INVIMA has enacted several resolutions for different foods and the safety requirements manufacturers must comply with to import and distribute food products in Colombia.
For example, Decree 616 of 2006 provides all the technical requirements for milk to be suitable for human consumption, Decree 1673 of 2010 sets forth the requirements for labelling milk powder as a raw material for the food industry, and Decree 1880 of 2011 establish the chemical and physical characteristics necessary to market milk for human consumption in Colombia.
For meat derivatives, Decree 2162 of 1983 regulates the production, processing, transport, and sale of processed meat products made from meat, fat, offal, and edible by-products of authorised animals.
Finally, concerning nutrition supplements, Decree 3249 of 2006 establishes the health regime for this type of product, as well as the control carried out by INVIMA to ensure that nutritional supplements comply with the technical specifications to be marketed in the country.
The general rules of Colombian consumer protection law governing product safety are applicable to cosmetics, biocides and food and nutrition supplements. Therefore, if the manufacturer or any other party in the commercialisation chain become aware of a manufacturing or design defect, the issue must be reported, and a recall of the product conducted.
According to the Colombian health regulation, both medical apps and wearables are considered types of medical devices, and therefore their product safety regulatory regime is included within Decree 4725 of 2005.
Resolutions 2654 and 3100 both of 2019 implemented a series of provisions related to telemedicine. These resolutions establish which type of health services can be provided through telemedicine, the requirements placed on the technological platforms, and patient data protection provisions.
Concerning CBD and all cannabis derivatives, Decree 613 of 2017 establishes the main regulatory framework for growing seeds, producing cannabis, and manufacturing cannabis products. Notwithstanding the above-mentioned Decree, CBD is only an ingredient and cannot be sold to the final consumer if it is not in the form of a drug, cosmetic, or a phytotherapeutic product.
To outline the difference between a medicine and a medical device it is necessary to analyse if there is an active pharmaceutical ingredient and the specific definition of these products.
A medical device is considered an instrument, machine, device, software, biomedical device, or any other similar item used to diagnose, prevent or relieve a disease. On the other hand, even though a drug also has a diagnostic, preventative or disease-relieving purpose, pharmaceutical products are prepared with an active pharmaceutical ingredient. Therefore, the primary way to differentiate a drug from a medical device is the active pharmaceutical ingredient included in pharmaceutical products.
On the considerations for the classification of biocides products, please refer to 1.2 Healthcare Products.
As a general rule, for imported products, manufacturing entities must fulfil all their local requirements to market and sell their products in their country. INVIMA will not request further information on the manufacturing site; however, companies will have to provide a certificate of free sale to obtain marketing authorisation for their products.
If the products are manufactured in Colombia, a good manufacturing practices (GMP) certificate will be necessary to produce medical devices or healthcare products.
Nevertheless, the requirements for manufacturing sites or the design or specifications of products will vary depending on the nature of the product.
Regarding the standards that manufacturing sites must comply with, the Colombian regulatory agency demands a list of all the international standards followed by the manufacturing site for medical devices. In our experience, manufacturing sites generally follow the ISO 13485 or other quality management systems that focus on risk management and design control activities.
The design of medical devices should be focused on minimising risk as much as possible. If it is not possible to eliminate the risks, it is necessary to take appropriate protection measures, including alarms. Finally, the manufacture must inform the user of any residual risks.
The packaging of the product should:
Drugs and Blood Products (Biologicals)
For pharmaceutical drugs and blood products, the manufacturing site must have a GMP certificate issued by the FDA, EMA, WHO, PAHO or by the regulatory authorities of Canada, Germany, Switzerland, France, the United Kingdom, Denmark, Holland, Sweden, Japan, and Norway.
Resolution 1160 of 2016 provides the standards for GMP for pharmaceutical products. This regulation includes a series of requirements that seek to ensure that products are consistently produced and controlled to the quality standards appropriate for their use and required for marketing authorisation. In this way, the GMPs are mainly oriented to reducing risks inherent to pharmaceutical production, such as cross-contamination and confusion due to mislabelling.
The benefits of the design of this type of product must outweigh the possible risks. Furthermore, studies must demonstrate that these products are safe for human consumption and effective for the uses attributed to them.
Cosmetics have to be produced following the GMPs outlined in Annex 2 of Decision 516 of 2002 that set out the GMP standards to be followed by the cosmetics industry.
The GMP standards include the following rules:
Cosmetics should not be harmful to human health when applied under normal conditions, and the components of the product must be accepted by one of the following:
Household Hygiene Products
As in cosmetics, these products must not harm human health when applied under normal conditions. Manufacturers shall include instructions for use and disposal, as well as any other indications or information relevant to their use.
Manufacturers must have a certificate of good manufacturing practices for nutrition supplements to obtain the marketing authorisation of their product in Colombia.
Human or animal hormones, pesticide residues, antibiotics, or veterinary drugs are not allowed in nutrition supplements. Narcotics, psychotropic or dependent substances are also not permitted.
For nutrition supplements, ingredients and additives prohibited in the codex Alimentarius or expressly in Colombian legislation are not accepted. Moreover, Colombian regulation accepts the substances, ingredients, or additives included in the Codex Alimentarius, approved by the FDA (Food and Drugs Administration) and the EFSA (European Food Safety Authority).
As for the specifications and design of food, there is a range of regulations governing food products. The manufacturer must refer to the specific rule applicable to the food type to be distributed in Colombia.
For example, for milk, the design, location, and maintenance of herd sites or areas and premises must ensure the minimum risk of contamination of raw milk of both intrinsic (animal) and extrinsic (environmental) origin. Furthermore, milking must be carried out in conditions that guarantee the health of the udder.
As for meat derivatives, every plant of processed products must have a sanitary operating licence. They may only use meat, fats, offal, and edible by-products of animals for slaughter that have been slaughtered in approved slaughterhouses. Processing plants must keep daily records of the origin and sales destination of the meat they process, as well as the approximate quantity of supply and means of transport used.
Concerning environmental obligations, with respect to detergents and soaps, the Ministry of Environment and Sustainable Development has issued Resolution No 689 of 2016, which establishes the standards related to phosphorus and biodegradability applicable to the surfactants of such detergents and soaps. Under this resolution, producers and importers of detergents and soaps with domestic, commercial, medical or industrial use are required to comply with such standards and provide the relevant technical information. Moreover, importers and producers of industrial soaps and detergents shall also conduct an administrative registration with the Environmental Licensing National Authority.
Under Resolution 371 of 2009, pharmaceutical producers and importers must design and implement a post-consumer (ie, take-back) programme for expired drugs, aimed at ensuring the proper environmental management of such products. For such purposes, collection point shall be made available at distributors’ facilities, for consumers to return expired medicines at no cost. Distributors must also inform consumers about the risks arising from consuming expired drugs, both for the environment and the patient’s health. Compliance with the obligations applicable to each agent is verified by the national environmental authority.
As a general rule, all claims and advertising must follow the conditions approved within the marketing authorisation of the products discussed in 1. Applicable Product Safety Regulatory Regimes.
Rules for Medical Devices
For medical devices, all advertising must be made according to the conditions established in the marketing authorisation. It should be based on scientific evidence, and the benefits cannot be exaggerated, nor can an advert defame or make pejorative comparisons with other brands.
Advertising in mass media is permitted for medical devices within classification I.
For medical devices of classification IIa, IIb, and III, companies can promote their products through scientific publications. For mass-media advertising, it is necessary to obtain authorisation from INVIMA for the referred classification IIa, IIb and III.
Rules for Drugs and Blood (Biological) Products
For drugs, all scientific or advertising information must comply with the provisions of the marketing authorisation, taking into account the authorised uses.
Advertising on mass media for prescription drugs is forbidden and shall be directed only to the medical body through scientific publications.
On the other hand, for over-the-counter medicines, the authorisation of INVIMA is required to advertise in mass media. In this type of advertising, the following information is necessary:
Rules for Cosmetics
As previously mentioned, cosmetics are not considered health products in Colombia. Hence it is not permitted to include therapeutic claims within the advertising of cosmetics.
Rules for Household Hygiene Products
Advertising of these types of products cannot induce behaviour that affects health. Furthermore, distributors cannot promote household hygiene products that do not have a valid marketing authorisation.
Rules for Nutrition Supplements
The advertising of nutrition supplements must be adjusted to the benefits attributed to each of the ingredients and must be previously approved by INVIMA.
The advertising must not induce or promote harmful eating habits or claim that the product can replace any food or that it provides people with extraordinary abilities.
Furthermore, it is not permitted to make any therapeutic claim or to suggest that the supplements are useful to prevent, relieve, treat or cure a disease, disorder, or physiological state.
Lastly, it is mandatory to include the following legend "This product is not used for the diagnosis, treatment, cure or prevention of any disease and does not supply a balanced diet".
Rules for Food
Advertising is made according to the nature of the food following the marketing authorisation of the product.
In food advertising, manufacturers cannot allude to medicinal properties, preventive qualities or include false assessments about the true nature, origin, composition, and quality of the food.
In addition, advertising should not suggest that the product is sufficient to replace a balanced diet or that it supplies in content and quantity all the nutrients required for a healthy diet.
Finally, for the advertising of energy drinks, it is necessary to obtain authorisation from INVIMA for its publication, and it is mandatory to include the following claims:
All the products discussed in 1. Applicable Product Safety Regulatory Regimes, including medical devices and healthcare products, require marketing authorisation from INVIMA. According to the nature of the product, this marketing authorisation has the denomination of a sanitary notification, sanitary authorisation, or sanitary register.
In relation to pre-marketing requirements, in all cases, the manufacturer shall gather all applicable technical information and evidence to obtain marketing authorisation.
In addition, and after obtaining the marketing authorisation, all batches of the final product must be manufactured according to the conditions quoted to INVIMA within the marketing authorisation submission.
Finally, concerning post-marketing obligations, particularly for medical devices that are considered biomedical equipment, both the manufacturer and its representative in Colombia have a duty to offer the services of calibration, maintenance, and supply of spare parts, as well as the training required both for operation and for basic maintenance of the biomedical equipment.
Currently, Colombia has free trade agreements with the USA, the EU, Mexico, Salvador, Guatemala, Honduras, the Caribbean Community, the Andean Community, Mercosur, Chile, Canada, EFTA and Venezuela. These agreements allow local manufacturers to enter international markets with low tariffs, fair competition conditions and a clear legal path for exports.
Colombia has a clear regulatory regime for most health products, and INVIMA is constantly evolving to evaluate the new technologies introduced by the industry. Moreover, INVIMA is considered a regulatory authority of regional reference that applies comparable regulatory standards to other regulatory agencies such as Cofepris (Mexico), Anvisa (Brazil), and Anmat (Argentina).
As for the flexibility of Colombian health regulation, in our experience, it is comparable to the regulation of other regions. However, for medical devices and pharmaceuticals products, INVIMA conducts independent assessments and may issue additional requirements not requested by other regulatory agencies.
Post-market Surveillance Obligations
In general, post-marketing surveillance obligations apply to all health products.
Notwithstanding this, with regard to medical devices, companies must comply with a technovigilance programme that involves reporting adverse events related to medical devices.
For drugs, manufacturers must have a pharmacovigilance programme that monitors and reports adverse events related to drugs.
There are no specific rules for record-keeping on adverse events reported by physicians or patients. Therefore, the general rule, applicable to all business, regarding record-keeping is to maintain all registers that support the relevant business (ie, ledgers, journals. etc) for ten years.
In cases where there are products that pose a risk to consumers' health due to a manufacturing defect or new safety information, the company must notify INVIMA of the situation. In this event, the company will be obliged to withdraw from the market all existing units of defective products, using all necessary means for this purpose.
Notification to Regulatory Authorities
As noted above, in medical devices, companies must maintain a technovigilance programme that ensures the follow-up of adverse events that medical devices may cause during their use. In the case of serious adverse events, the report must be made within 72 hours of the event or incident. All other adverse events, these should be presented quarterly, including the company's preventive measures.
Likewise, suppose there is an international alert reported by the parent company or by any health agency worldwide regarding medical devices marketed in Colombia. In that case, the company must report the situation to INVIMA within 72 hours of becoming aware of this alert.
In the case of drugs, within the pharmacovigilance programme of pharmaceutical companies, severe and unexpected adverse events must be reported within 72 hours of knowledge. Equally, international health alerts on a product marketed in Colombia must be reported within 72 hours.
Expected or non-serious adverse events should be reported every two months.
The Consumer Protection Statute establishes certain duties in connection with recalls. Although product specific rules supersede the general provisions of consumer protection laws, the Superintendence of Industry and Commerce has stated that the duty to report the recall is applicable to all products that may cause harm to consumers.
Accordingly, recalls must be reported to the Superintendence of Industry and Commerce in accordance with the rules outlined in 1.1 Medical Devices, even if there is a concurrent duty to inform INVIMA of the recall, except in the cases of pharmaceutical products (Drugs and biological drugs).
Medicines, medical devices, and – generally – products for human consumption in Colombia are regulated and monitored by the National Institute for Drug and Food Surveillance (INVIMA).
Thus, INVIMA is responsible for controlling and authorising the manufacture, import, and marketing of medicines, medical devices, cosmetics, food, beverages, alcoholic beverages, and diagnostic reagents, among others.
The Superintendence of Industry and Commerce is Colombia’s consumer protection agency. As such, it has jurisdiction over all industries and products not under specific surveillance by another agency. Please note that, as stated before, the Superintendence of Industry and Commerce may have concurrent jurisdiction with INVIMA when dealing with recalls.
Taking into account that INVIMA is the national regulatory agency in health matters, it has a total authority to:
The Superintendence of Industry and Commerce has jurisdiction to oversee the duties of producers and suppliers of all types of products concerning:
As a general rule, all medical devices and healthcare products introduced to Colombia must comply with all the specifications and conditions stipulated within the submission to obtain marketing authorisation.
Furthermore, during the marketing of the product, the distributor must comply with the sanitary requirements and quality control to secure safe products for the public.
If a company fails to comply with the sanitary and quality requirements, the following penalties will apply:
Failure to follow the Consumer Protection Statute rules governing product safety (ie, failing to report a known dangerous defect or to undertake the appropriate steps to stop commercialisation or repair existing products) is punishable by fines.
The Superintendence of Industry and Commerce may levy fines of up to 2,000 times the Colombian minimum monthly wage (COP1.8 billion in 2021, about USD500,000).
Aside from fines, the Superintendence can issue specific instructions, such as market withdrawal orders.
Product liability is actionable under the general non-contractual civil responsibility (tort) provisions. Accordingly, if a product causes harm to persons or property, the injured party has a right to seek compensation.
Individual tort causes of action may be filed before the general courts. Class actions may also be filed in connection with product safety claims, provided that there are at least 20 actual or potential claimants.
Individual claims for compensation of damages can only be filed if the plaintiff has attempted a mandatory pre-trial mediation with an impartial mediator. If the mediation fails, or the defendant fails to appear at the mediation hearing, the minutes prepared by the mediator must be submitted alongside the complaint. The general statute of limitations is set at ten years.
Class actions are not subject to the pre-trial mediation requirement, but during the procedure, before the evidence hearing is conducted, the judge must convene the parties to conduct a mediation hearing. The statute of limitations for class actions is set at two years, once the term lapses class actions are time barred but individual claims may still be litigated if the general statute of limitations has not lapsed.
Other than standard settlements, which include provisions as to costs, there are no specific measures available to protect against cost orders. Settlements are finalised in a contract known as a transaction in which the parties can provide for the termination of judicial proceedings through a joint motion in which the court is asked not to assess any costs.
There are no specific provisions involving product-related contentious matters. However, fines and penalties ordered by the Superintendence of Industry and Commerce or INVIMA involving product safety issues can be subjected to judicial review by administrative courts. In those cases, the litigation will involve both procedural (eg, due process issues) and substantive questions. The latter ones allow the administrative judges to review the findings of these entities concerning the safety of a product.
Class actions allow for mass tort litigation involving plaintiffs with a common claim, for further details please refer to 4.7 Class Actions, Representative Actions or Co-ordinated Proceedings?
Class actions are available and allowed under Colombia law, and may be used to litigate any controversy involving product safety claims. Class action decisions bind the entire class, unless a specific opt-out request is filed within a prescribed term before the court hearing the proceeding.
A recent example in Colombia involves a class action, currently being litigated, filed by a group of women to whom the HPV vaccine was administered. The group alleges the existence of adverse effects attributable to the vaccine and are seeking compensation (material and pain and suffering damages).
Under Colombian law, parties can freely agree to:
Superintendence of Industry and Commerce decisions regarding product liability can give rise to individual and class actions seeking compensation, as the penalties are well publicised and can be included as statements of fact in the specific claims. However, the administrative decisions issued by Superintendence of Industry and Commerce are not, themselves, considered as evidence of liability or even as proof of a defect in a product.
Under Colombian law corporations are not subject to criminal prosecution, although they may be ordered to pay damages by criminal courts in the context of the prosecution of individuals who acted on behalf of the company.
Currently, there are no emerging trends in respect of the environmental impact of consumer packaging and/or the manufacturing processes of medical devices and healthcare products.
Due to the widely publicised case of the death of a patient who received and took the wrong medicine due to the similarities of its packaging with other medicines, there is an initiative that seeks to regulate the similarities between pharmaceutical packages to avoid confusion. However, the bill of law was not approved by Congress.
A project is currently underway to amend the marketing authorisation regime for pharmaceutical and biological products.
Under this amendment, all renewals would be granted automatically. INVIMA would carry out a subsequent review of the product and issue requirements if necessary.
In addition, this project regulates in greater depth the modifications made to the marketing authorisations and divides them into minor, moderate, and critical risk modifications.
Minor risk modifications will not require authorisation from INVIMA, moderate risk modifications will have an automatic authorisation procedure, and critical risk modifications will require a preliminary review from INVIMA before the authorisation is granted.
Finally, the project mentions the possibility of presenting information to patients through websites and regulates the marketing of medicines through digital platforms.
Brexit has had no appreciable impact on the Colombian medical devices and healthcare products regulatory regime.
Due to the impact of COVID-19 and the urgency of implementing a successful vaccination programme, the Colombian government sponsored the adoption of legislation that created a special rule governing liability related to COVID-19 vaccines.
Specifically, under Law 2064 of 2020, manufacturers of the vaccines are only liable for gross negligence and non-compliance with GMP. The law also established a special compensation system inspired by the no-fault compensation developed in other countries, by which actions arising out serious adverse events after the administration of the vaccines must be filed in administrative courts. If liability exists, compensation must be provided by the government.
Furthermore, claims may only be filed after having requested and received an opinion from a scientific and technical body, known as the adverse reactions evaluation council, in which the causal link between the administration of the vaccine and the alleged injury is reviewed.