Ultimate Guide for Regulatory Affairs in Colombia
This guideline is prepared to explain all the requirements, processes, timelines and other important matters you need to know to register your devices in Colombia.
To facilitate your information search, this guide details each of the following topics:
The legal framework surrounding a medical device in Colombia
INVIMA (the National Institute for Food and Drug Surveillance) is in charge of assuring the safety and efficacy of products (including Medical Devices) distributed in Colombia. INVIMA’s website facilitates the consultation of the applicable regulation for Medical Devices, including the rules to get a product approved. Some of the key regulations related to Medical Devices are:
Laws
- Law 100 of 1993
- Which regulates the origin of the entire system of social security of the country, and which instructs the creation of INVIMA.
- Law 715 of 2001
- That dictates the expedition of applicable regulations to the healthcare sector.
- Decree 612 of 2000
- Which regulates the releasing of automatic or immediate registrations (only applicable for Class I and Class IIa devices).
- Decree 3770 of 2004
- Which express the rules to get the registration for IVDs and the respective post-marketing surveillance.
- Decree 4725 of 2005
- Indicates the conditions and requirements to get a sanitary registration, a commercialization permit and regulates the post-marketing surveillance of medical devices.
- Decrees 4562 of 2006, 3275 of 2009, 582 of 2017
- These are examples of decrees that have modified articles in the Decree 4725 of 2005 over time.
- Decree 476 of 2020
- Indicates the actions and conditions to prevent, diagnose and treat COVID-19.
- Resolution 2511 of 1995
- That dictates the adoption of a technical standards manual for a range of products, including medical devices.
- Resolution 132 of 2006
- Manual of warehousing conditions for IVDs
- Resolution 4816 of 2008
- Which establishes the National Program of Technovigilance.
- Resolution 522 of 2020
- Details the rules to import and manufacture IVDs, medical devices and other healthcare products required for the prevention, diagnosis and treatment of COVID-19.
As mentioned above, the INVIMA website is a well-organized place where you can make a further research for a specific topic.
Inside INVIMA Colombia
Headquartered in Bogotá and with presence in different locations in Colombia, INVIMA (the National Institute for Food and Drug Surveillance) started operations in 1995. Since then, it has evolved to finally being redesigned in 2012 to consolidate itself. INVIMA is an ISO 9001:2008 certified agency and has been recognized by the Pan American Health Organization (PAHO) as a National Authority to regulate medicines in Latin America.
INVIMA’s scope involves products, such as: medicines, biological products, natural and homeopathic products, reagents of in vitro diagnostics, medical devices, processed foods, meats, packaged drinks, alcoholic beverages, cosmetics, condoms, among others.
The stakeholders in a regulatory project in Colombia
If you are a manufacturer, an independent regulatory consultant, or a local distributor, it is important to understand the key roles of the main stakeholders. This will provide a better understanding of your legal responsibilities and/or common roles in a project.
Manufacturer
The person or company responsible of designing, manufacturing, packaging and labeling of a medical device. Other specific operations may be required depending on the nature of the product.
Registration holder
It is the person or company that owns the registration on behalf of the manufacturer and is responsible for applying for the new registration, modifications or extension to the device license (registration). It is worth mentioning that this entity does not need to be located in Colombia.
Authorized Importer and Distributor
It is the person or company that has been authorized to import and commercialize the product, and that has previously received a Certificate of Warehousing and Conditioning Capacity (CCAA). This entity must be located in Colombia.
Technical Director
It is a technical responsible person with an appropriate major related to the nature of the medical device field and that is hired by the Importer.
The routes to register a medical device
At this point, we have identified the rules and specific documents that lay behind every medical device sold in Colombia. In addition, we have identified the main stakeholders in a regulatory project. Now, it is time to talk in detail about the routes you can choose.
First of all, it is necessary to determine whether the product is a:
- Non-Controlled Technology Biomedical Equipment
- Controlled Technology Biomedical Equipment or
- In Vitro Diagnostic Product
Once this is defined, we have to identify the classification/category:
- For Medical Devices and Biomedical Equipment
- Class I
- Class IIa
- Class IIb
- Class III
- For In Vitro Diagnostic Devices
- Category III
- Category II
- Category I
Non-Controlled Technology Biomedical Equipment
Non-Controlled Technology devices are subject to the following two registration routes:
- Automatic Sanitary Registration (with Posterior Controls)
- Sanitary Registration (with Previous Controls)
Automatic Sanitary Registration (with Posterior Control)
This is the registration route to follow for Non-Controlled Technology Biomedical Equipment located in Class I or Class IIa. Such devices require an automatic sanitary registration issued by INVIMA to be manufactured, imported, exported, processed, packaged, warehoused and commercialized in Colombia.
By using this route, you will have to submit the registration dossier to INVIMA, who will review it for full compliance. INVIMA will release the registration within 2 days upon confirmation. This is the official timeline but the real timelines may be longer in practice.
It is important to know that although the registration has been released, the INVIMA may continue the revision, and if it is detected that additional information is required, it could be requested to the registration holder, who will have up to 90 days to attend the requirement. Otherwise, the registration will be cancelled.
Sanitary Registration (with Previous Control)
This is the registration route to follow if your product is a Non-Controlled Technology Biomedical Equipment Class IIb or Class III. Similarly, these kind of products require of a sanitary registration issued by INVIMA. But in this case, the Ministry of Health will review the registration dossier in detail prior the authorization, which could take up to 4 months upon submission.
Another difference is that INVIMA might request samples of the products to be analyzed before the authorization of the products.
Controlled Technology Biomedical Equipment
A further significant route to be considered is when the device is a Biomedical Equipment of Controlled Technology. These devices are subject to special controls due to their particular characteristics, such as:
- High risk and vulnerability
- If they are used
- When the device is a prototype with scientific improvements
If the mentioned scenarios prevails, it is necessary to get a Commercialization permit. This is a document required in order to manufacture, import, export and/or sold within the country. Article 24 of the Decree 4725 of 2005 enlist the requirements to get this permit. It is worth mentioning that spare parts required to fix or provide maintenance to these equipment also require a Commercialization Permit.
In-Vitro Diagnostic Products
Last but not least, it is important to mention that for INVIMA, IVDs are somehow treated separately from the medical devices. First of all, their classification is given by three different categories, based on their level of risk: Category III, Category II and Category I (for high, medium and low risk, respectively).
The IVDs in Category III do require a sanitary registration to be manufactured, imported, exported, warehoused and sold in Colombia, unless they are being commercialized in USA, EU, Canada, Japan and Australia.
The IVDs under category II and category I also require an automatic sanitary registration to be manufactured, imported, exported, warehoused and sold in Colombia. Articles 10, 12 and 13 of the Decree 3770 of 2004 details the requirements and procedures to apply for this registration process. As it happens for the Non-Controlled Technology Biomedical Equipment in class I and class IIa, the automatic registration is released a few days upon submission, although INVIMA will continue with the evaluation of the information.
For all these processes, INVIMA has developed a site where the companies and users can apply for a registration fully on-line. You can visit the INVIMA site, sign up and perform the payment of an application to submit the dossier or upload documents for INVIMA’s review.
Timelines
We have talked about the timelines. In an effort to make this easy for you, this is a summary for different pathways and processes. Please consider that none of them is based on legal information but rather on our experience throughout the years. In addition, these timelines are based upon submission of your documents to INVIMA.
- Automatic registration for Biomedical Equipment (Class I and Class IIa) and IVDs in Categories I and II:
- 1 month after completing the revision of the submitted information.
- Registration for Class IIb and Class III or Commercialization Permit:
- 4 months upon complete reception of the requirements.
- Registration of IVDs, Category III:
- 4 months upon complete reception of the requirements.
- Modifications to registrations due to slight changes to the product or the stakeholders:
- 1 month upon submission.
It is worth mentioning that IVDs registrations in Category III are valid for 5 years. The rest of approvals, by means of the registrations for medical devices (Class I, Class IIa, Class IIb, Class III), the IVDs in Categories II and I, and the commercialization permits are valid for 10 years and these periods can be extended by the proper procedures and timelines, accordingly.
What is a request of additional information
The INVIMA has the authorization to request documents or explanations concerning to a sanitary registration either it has been approved through the Automatic Registration or not. In any case, the holder can be requested to submit extra information in order to be compliant with the local regulation. That being the case, there is an average response time of 90 days, starting a day after INVIMA request it.
As it happens in other countries, if the Holder does not attend the notification from INVIMA, the registration might be cancelled (in case of an automatic registration) or the application can be withdrawn, having to start over the entire process.