Article gives overview of the medical device regulations in Colombia.
The institution responsible for medical device regulations in Colombia is INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). INVIMA, similarly to the EU, uses a risk-based classification system. Medical devices in Colombia are classified into four classes: I, IIa, IIb, and III. Class I medical devices are associated with the lowest risk and class III medical devices are associated with the highest risk.
Colombia — like Argentina, Brazil, Paraguay, and Uruguay — is a full member of Mercosur (official Southern Common Market), a South American trade bloc established in 1991 used to promote free trade and fluid circulation of goods, people, and financial assets between the member states.
As of May 1, 2006, the medical device registration process for the Southern Common Market countries have been unified. Currently, there are ten harmonized medical device regulations for Mercosur member states (including premarket approval, vigilance reporting, and training of the inspectors).
How to register your medical device in Colombia?
The timeframe for medical device registrations in Colombia varies depending on the risk classification of the device. The registration process takes about two to three months for Class I and IIa medical devices, and from about four to six months for Class IIb and III devices.
Before proceeding with the registration process in Colombia, manufacturers must first register the device in their home country. Alternatively, it is possible to provide Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from either the European Union, United States, Australia, Canada or Japan. Issued registrations are valid for 10 years and the renewal application should be submitted 3 months prior to the expiration date.
Foreign manufacturers are required to appoint an Authorized Representative and submit all relevant documents in Spanish. Relevant documentation includes:
- Product information
- Test reports (for Class IIa, IIb, and III devices)
- Data from clinical trials (for class III devices)
Detailed information regarding required documents can be found in Articles 18, 19, 24, and 29 of Decree 4725/2005 (document in Spanish).
It is also possible to have the device registered immediately, although this option is available only for Class I and IIa medical devices. In order for this to happen, manufacturers are required to provide full technical documentation along with the application. If the review by INVIMA is successful, the certification is granted immediately. However, it does not release the device from the official review process. Throughout this review process, manufacturers are obligated to provide answers to any questions INVIMA may have during formal review period.
In Vitro Diagnostic (IVD) devices
Framework for IVD devices in Colombia is different than for medical devices. IVD devices are also classified accordingly with the risk-based model, but instead of being classified into four classes, they are classified into three classes: I, II, and III, each holding higher risk to the human body, respectively.
In early April 2017 INVIMA introduced Decree 581/17 (document in Spanish), which provides some substantial changes to the IVD regulations in Colombia. The first change concerns only Class III IVD devices and makes it obligatory for manufacturers to submit the device to an additional review conducted by specialized review boards. However, there are exceptions to this rule. If the device is already marketed in the European Union, United States, Australia, Canada or Japan and a Certificate of Free Sale was issued less than a year from the date of application submission, the device is not subject to additional review.
The second substantial change concerns Class I and II IVD devices in which registration renewals are now processed automatically. However, additional information regarding the device may be requested at any time and manufacturers have 30 days to provide answers to any questions the review board may have.