FAQ: Medical Device Regulatory Registration, Legal Representation, and Importer of Record in Colombia

 

Colombia Regulatory Frequently Asked Questions

VIDEO: Colombia medical device regulatory overview

What's the name of Colombia's medical device regulatory agency? 

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA): www.invima.gov.co

Is there a document in English that summarizes Colombia's regulatory framework for medical device registration?

Yes, please see the World Health Organization's summary for Colombia here

What is the medical device classification system in Colombia?

Colombia's INVIMA medical device classification system is based on the potential health risk related to the use and possible failure of a device. The criteria used involves duration of contact with the body, how invasive the device is, and local effect vs systemic effect. 

  • Class I
    • Low risk
    • Subject to general manufacturing controls
    • No potential harm of disease or injury
    • Not destined to protect or maintain life
    • Made to prevent the deterioration of human life
    • Examples: Surgical instruments, gauze
  • Class IIA
    • Moderate risk
    • Subject to special manufacturing controls to demonstrate their safety and efficacy
    • Example: Hypodermic needles, suction equipment
  • Class IIB
    • High risk
    • Subject to special controls in their design and manufacturing to show safety and efficacy
    • Example: Pulmonar ventilator, orthopedic implants
  • Class III
    • Very high risk
    • Subject to special controls to protect or maintain life 
    • Made to prevent the deterioration of life
    • Their use represents a potential health risk or injury 
    • Example: Heart valves, pacemakers

Source: ABC de Dispositivos Médicos INVIMA

What are the document requirements and steps to register a medical device in Colombia? 

  1. Appoint an in-country legal representative if you have no local presence in Colombia (optional).
  2. Appoint an importer of record (IOR) and an INVIMA-certified storage company with a valid CCAA certificate.
  3. Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from your home country or an INVIMA recognized market (e.g., USA/FDA, EU/CE Marking). 
  4. Provide quality system certificate (e.g., ISO 13485, GMP).
  5. Provide product information and commercial history of the product; test reports will be required for Class IIa, IIb and III devices, and clinical data will be required for Class IIb and Class III devices.
  6. Submit the final dossier to INVIMA in Spanish and pay the required application fee.
  7. Once approved, INVIMA will issue a registration certificate. INVIMA automatically approves Class I and IIa applications, so you can begin selling right away. The agency will still review the application, and manufacturers must respond to any additional information requests within 30 days. Failure to comply will result in approval being revoked.

Note: This is a simplified overview of the process. Click here for a more detailed list of document requirements. INVIMA may choose to audit your submission and request more documents, which will add time to your approval.

What parties do I have to name in my medical device registration application at INVIMA in Colombia?

You will need to name three parties in your application to INVIMA:

  1. The title holder of the registration certificate (e.g., your company as a foreign manufacturer)
  2. An importer of record (IOR) company (e.g., your local distributor or a third-party logistics operator)
  3. An INVIMA-certified storage company (e.g., your local distributor or a third-party logistics operator)

You as a foreign manufacturer (or a local third-party that you appoint) will be the title holder of the registration. Any local company in Colombia could be your IOR as long as it is certified by INVIMA to store medical products. INVIMA issues a special certificate to medical device storage companies (aka CCAA or Certificado de Capacidad de Almacenamiento y/o Acondicionamiento). Many logistics companies in Colombia have this certificate. 

Does my company have to appoint a legal representative in Colombia?

Colombian law does not specifically mandate foreign medical product manufacturers to appoint an in-country regulatory legal representative. Most foreign manufacturers that do not have a local office in Colombia appoint an in-country legal representative for practical reasons (e.g., to manage the submission of the initial registration, receipt of notices, reporting of adverse events, to file the mandated annual post-market surveillance report, and to be the liaison between the manufacturer and its distributors). 

What is the role of a regulatory legal representative in Colombia

Foreign manufacturers must issue power of attorney to a local third-party in Colombia if they would like to have that third-party represent their interest while doing business in Colombia and communicating with INVIMA on their behalf.

Most foreign manufacturers that have more than one distributor in Colombia, appoint a legal representative to submit their INVIMA registration application, and to manage all regulatory aspects of doing business in Colombia. This way, foreign manufacturers have an independent third-party looking after their interest in Colombia.

The legal representative acts as a liaison between you, INVIMA, and any other private or government entity. Medical device manufacturers that do not have a physical location within Colombia usually appoint and maintain that legal representative for as long as they market and sell their products in Colombia.

Your legal representative in Colombia will manage your product registration process, will interact with INVIMA on your behalf, will receive legal notices on your behalf, and will ensure that you comply with local post-marketing surveillance requirements (i.e., filing the mandatory annual report). 

We can act as your legal representative in Colombia, fulfilling all regulatory responsibilities per national health regulations. When you assign power of attorney to us,

  • We will place our name, mailing address, email address, and phone number on your device submissions and registrations to INVIMA.
  • We will receive all INVIMA notices about your product, review them and share them with you to establish the best course of action. 
  • Upon request by INVIMA, we will provide information about your product, and names and addresses of distributors established in Colombia. We will have access to your product documentation for inspection by INVIMA if requested. Note that we can only supply this information for inspection by INVIMA upon written permission from you and cannot share it with any other person or entity.
  • We will be available to make changes (e.g., switching importer of record) to your existing registration certificate.
  • We will be available to coordinate inquiries, analysis and responses for reportable adverse events as reported by users, distributors, importers of record or INVIMA. We will help you determine the best response.
  • We will be available to provide technical assistance for the reporting of adverse events as reported by users, distributors, and importer of record.
  • We will be available to make certain your distributor or importer of record follows Colombia's post-market surveillance regulations.
  • We will be available to act as a liaison between INVIMA and you in case of recall or risk for product withdrawal from the market.
  • We will be available to submit to INVIMA the required annual report (if applicable to your product) stating:

    • Number of imported products

    • Number of sold products

    • Location of all sold products

    • Serial number of all sold products

    • Serious adverse events and the actions taken

What's the role of an importer of record in Colombia

You will need to name three parties in your product registration application to INVIMA:

  1. The title holder of the registration certificate (e.g., your company as a foreign manufacturer)
  2. An importer of record (IOR) company (e.g., your local distributor or a third-party logistics operator)
  3. An INVIMA-certified storage company (e.g., your local distributor or a third-party logistics operator)

You as a foreign manufacturer (or a local third-party that you appoint) will be the title holder of the registration. An importer of record (IOR) is a legally formed entity under Colombian law that has been classified as an "importer" by Colombia's custom agency (DIAN). Any local company in Colombia that is certified by INVIMA to store medical products could be your storage company. INVIMA issues a special certificate to medical device storage companies (aka CCAA or Certificado de Capacidad de Almacenamiento y/o Acondicionamiento). Many logistics companies in Colombia have this certificate. 

If a manufacturer only has one distributor in Colombia, very likely it will appoint this distributor as its IOR. If a manufacturers has more than one distributor in Colombia, it will very likely appoint a third-party company as its IOR (preferably a logistics company that is also certified by INVIMA as a storage company). 

The role of the IOR is to apply for import permits at Colombia's Ministry of Industry and Commerce (VUCE office) and to interact with Colombia's customs agency (DIAN) to nationalize the manufacturer's products in Colombia.

Could I appoint my distributor as my regulatory legal representative in Colombia?

Some manufacturers have considered appointing a Colombian distributor to fulfill this role. While it is possible to appoint a local distributor, there are valid reasons not to appoint a distributor as your legal representative, including:

  • You may need to provide access to your device information and documentation (mandatory for registration purposes) and most companies prefer not to put (confidential) design information in the hands of their distributors.
  • A conflict of interest may occur in the event of recall and/or incident reporting between you (the manufacturer) and the distributor. If INVIMA questions an incident or a non-compliance that occurred in the distribution system, will your distributor defend his company or yours?
  • The distributor is focused on sales and marketing, not on regulatory affairs. They may not keep you up-to-date on regulatory changes in the market and provide timely warnings when changes affect your devices.
  • The legal representative will assign an initial distributor or a logistics operator to act as your importer of record, and may need to assign additional distributors to your INVIMA registration certificate. If you select us as your legal representative in Colombia, we will would fully cooperate with you so that you control all regulatory aspects of your device on the market.

What are the specific labeling requirements for submission to INVIMA? 

  • Original artwork (if applicable). 
  • The artwork in Spanish with at least the following information: product name or reference, manufacturer's name and address, and internationally recognized safety symbols. 
  • Artwork for a separate label in the form of a sticker with the following information: name of the importer of record, product name, product model or reference number, importer of record's name and address, registration certificate number, and classification of the device (I, IIA, IIB y III). 

What documents does my company need to translate? 

The number of documents to translate will depend on the classification of your device. The steps above tell you what documents you generally need to submit to INVIMA in Spanish. Registration materials pertaining to biocompatibility, risk analysis, sterilization, and clinical studies and test reports may now be submitted to reviewers in their language of origin; summaries of study descriptions, methods and conclusions must be provided in Spanish.

Once we review your product information, we will be able to tell you exactly what documents you need for submission. Please bear in mind that after submission and INVIMA internal technical review, it may ask for additional documents at its discretion. You must translate to Spanish your devices' operations and maintenance manuals. Please review INVIMA's official website (in Spanish) for detailed information about submission requirements.

Any legal document (e.g. power of attorney) must have an Apostille and must have its respective "official" translation by a translator who is certified by Colombia's Ministry of Foreign Affairs. 

What are the costs associated with translating the submission documents to Spanish? 

Our standard rate per word translated to Spanish is USD $0.25. This rate may change without further notice. However, we will ask you whether you want us to handle the translations locally in Colombia for you or if you prefer to send us the documents in Spanish. Please be aware that there are slight differences in the way Spanish-speaking countries use the language. INVIMA prefers to receive documents in "Colombian" Spanish so that their staff and the general public can easily understand them in Colombia. 

How long will it take for you to review our documents and assemble the final dossier package to INVIMA?

Generally, it will take about 30-60 days. The time will depend on whether you have all the technical and legal documents ready for us to review or not. You will need to notarize and Apostille some legal documents and ship them to us by courier; this may delay the review and assembly process. 

Can my company start selling in Colombia as soon as INVIMA receives a submission for medical device approval? 

INVIMA automatically approves Class I and IIa applications, so you can begin selling right away. The agency will still review the application, and manufacturers must respond to any additional information requests within 30 days. Failure to comply will result in approval being revoked. For Class IIb and Class III INVIMA must review and approve your application before you can begin selling; the review could take 4-6 months. During this review, they may ask follow-up questions or request additional information.

Is home country approval required? 

If you don’t have approval in your home market, then you can provide a CFS/CFG from one of the following markets: Australia, Canada, Japan, Europe, or the United States.

What if we do not have ISO 13485 certification for medical devices? 

The regulation requires proof of a QMS (such as ISO 13485); however, if your company doesn't have it, then you can meet this requirement by providing an ISO 9001 certificate, an FDA Establishment Report, or some other equivalent document. 

How do I control my approval with you as my legal representative? 

When foreign manufacturers trust their local distributor to register their products in Colombia —instead of an independent third-party regulatory legal representative— the distributor will often list itself as both the holder and importer of record of the registration. This means that the distributor is in total control of your product registration (and commercialization) in Colombia; any future modifications, such as adding a new distributor, models, etc., would need to be authorized and processed at INVIMA by the distributor itself.

Please note that it's not in the distributor's best interest to relinquish its ownership of the registration certificate. This forces the foreign manufacturer to re-start the process of registering the product when in need to change its distributor in Colombia —duplicate product registrations are allowed in Colombia. As your legal representative, We will register your product in your company's name, ensuring that you have 100% control over your registration and the commercialization of your products; this way, you will be able to switch at will the importer of record (a local commercial distributor or a logistics operator) of your product registration.

Can I transfer my registration certificate to another registration holder? 

Registrations can be transferred in Colombia as long as the original holder (a local distributor, in most cases) would agree. If the holder is a distributor, it is usually not willing to give up control of a registration, and often foreign medical device companies need to submit a new application and incur additional costs. When you appoint us as your regulatory legal representative, you can change your registration as needed and have total control over the commercialization of your product in Colombia.

We will submit the INVIMA application with your company as the holder and controller of the registration. It is advisable that you have a third-party logistics operator (independent from your distributor) be your registration's importer of record (as opposed to having one local distributor as the entity that imports and stores your products); this way, you will be able to have several distributors in Colombia —your logistics operator will be able to import products on your behalf, store them in its INVIMA-certified warehouse; as distributors place orders with you, your logistics operator will ship products domestically to your distributors' preferred shipping address in Colombia. 

Are there any INVIMA requirements for distributors so that they can officially sell my company's products in Colombia? Does INVIMA and/or the regulatory legal representative or manufacturer have to officially “recognize" them as commercial distributors? 

No.

Can my company sell directly to end-users in Colombia? 

Yes, as long as your end-user (buyer) contacts your IOR in Colombia to process the physical importation of your medical device. Bear in mind that your IOR may be a logistics operator or a commercial distributor. 

Can my company register the products that a former distributor had already registered? 

Yes. Colombian allows duplicate registrations. A foreign manufacturer can register its products in Colombia despite the fact that its current distributor has already registered them. Bear in mind that your company will have to pay for this registration process as a new submission and re-submit all necessary documents (INVIMA will not grandfather a prior submission or give you access to prior documents). We, as your company's local regulatory legal representative, could handle this process for you. Your company will have to name a new IOR on the new application submission.

Whom do I name as an importer of record (IOR) in my product registration certificate application submission to INVIMA? 

On the application form for the new registration, we will add the name of the importer of record (IOR) of your preference. In some cases, the importer of record is a distributor. However, it could also be a logistics operator (this is the recommended approach). We can help you find a logistics company that can become your registration IOR (as opposed to having one local distributor as the entity that imports and stores your products); this way, you will be able to have one IOR (a logistics operator) and several distributors in Colombia. A third-party logistics operator will be able to import products on your behalf and store them in its INVIMA-certified storage warehouse. As distributors place orders with you, your logistics operator will ship products domestically to your distributors' preferred shipping address in Colombia. 

What if my company wants to amend (e.g. new importer of record, new manufacturer, new registration holder, product name, new label, use indication, risk classification, etc.) its existing registration certificate? 

It will be easily done after submitting a change request to INVIMA. INVIMA will take about 30 days to make the change after submission of the application. We will charge you our standard hourly rate plus any applicable INVIMA fee (approx. USD $150 to $250 depending on the type of change). 

What's the process to obtain an import permit in Colombia?

Once INVIMA issues your registration certificate, Colombia’s Ministry of Industry and Commerce (MinCIT) is the entity that issues import permits. You will need to provide MinCIT with a pro-forma invoice of the shipment, the INVIMA registration certificate, and complete an electronic application. You will need a separate import permit for each shipment. 

How do I ship something to Colombia that doesn't need an import permit? 

Sometimes manufacturers need to ship to Colombia products that are not part of their registration certificate but are commercial products (manufactured by third parties) necessary for the correct functioning of their medical devices (e.g. imaging calibration phantoms). In this cases, you will be able to ship them to your distributor or client in Colombia by express courier (i.e. DHL, Fedex, UPS) as long as the shipment complies with the following limits:

  • The shipment's declared value is less than USD $2,000
  • Weight is less than 50kg
  • Packaging dimensions should not exceed 1.5m on either side
  • The sum of the length of all sides of the package should not total more than 3m

What if my company wants to open a local sales office in Colombia or wants to switch to a different regulatory legal representative? 

It can be easily done. We will submit a formal request to INVIMA on your behalf. We will charge you our standard hourly rate plus any applicable INVIMA fee. We can also help you set-up your subsidiary new business entity in Colombia (read more). 

Does INVIMA need the name of my company's importer of record (IOR) in Colombia before the product registration certificate is submitted to INVIMA? 

Yes. INVIMA's medical device registration application form requires the name of your IOR upon submission. INVIMA has a rigorous certification process (also known as Certificado de Capacidad de Almacenamiento y Acondicionamiento, CCAA) to make sure importers of medical devices comply with storage, quality, and personnel regulations (Resolution 4002 of 2007). Any local entity in Colombia that has the CCAA certificate can be your importer of record. 

What power does the importer of record (IOR) have over my company's distributor(s) or regulatory legal representative? 

None. The IOR's only role is to be the official importer of your company's product in the Colombian territory. Colombia's customs agency (DIAN) will only let your company's IOR nationalize your products in the Colombian territory. No other third party in Colombia will be able to import your company's products and sell them to end-users. Your company's regulatory legal representative in Colombia will be able to act on your behalf to change the name of the IOR at your company's will. Your company's IOR does not control your regulatory legal representative nor it controls your distributors. Your company has full regulatory and commercial control over its IOR and its distributor(s). Your company may also choose to name a master distributor in Colombia as its local IOR. 

Could you be my company's importer of record (IOR)?

No, we are not a logistics operator in Colombia nor a commercial distributor. We can help you search and select the best local importer of record and distributor(s) for your company's products. 

What are the post-market controls for medical devices in Colombia?

Decree 4725 of 2005 and Resolution 4816 of 2008 set forth requirements for tracking of medical devices. Medical device reporting is required by Decree 4725 which mandates all stakeholders who become aware of adverse events to notify INVIMA. Additionally, INVIMA requires complete resolution and notification of any correction, removal or recall. Typically, the foreign manufacturer delegates this reporting requirement to either its regulatory legal representative, its importer of record, or one of its distributors in Colombia.

If your company appoints us as its regulatory legal representative in Colombia, we can take charge of this requirement by billing your company for the time involved per adverse event report submitted to INVIMA. Our standard hourly rate for regulatory work is USD $195/hour (this rate may change without notice, but will be agreed with your company upon execution of our regulatory legal representation contract). If you have more than one distributor in Colombia, your company certainly would want to centralize compliance of the reporting requirement with an independent third party such as its regulatory legal representative. 

Medical device registration title holders must also submit to INVIMA (with the help of their local regulatory legal representative) an annual report (Article 24, Decree 4725 of 2005) stating:

  • Number of imported devices
  • Number of sold devices
  • Location of all sold devices
  • Serial number of all sold devices
  • Serious adverse events and the actions that were taken

How do I renew a product registration certificate? 

You can submit an application for renewal 90 days before the expiration date of your registration certificate. Once a product registration certificate expires, then you will have to re-submit a new application. 

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About Julio G. Martinez-Clark: Julio is CEO of LATAM Market Access Inc. —an Orlando, FL-based market access company for medical device companies looking to expand their market, sell their products and conduct clinical trials in Colombia. The company offers a wide range of market access options including regulatory product registration, legal representation, distributor search, and trademark registration. Learn more.