*You can assign the function of the Legal Representative in Colombia to the Importer. In this case your Importer will control the registration process and own your registration certificates. To keep the registration under control companies appoint an independent Legal Representative. However, irrespective of whether the registration is managed by a Colombian Legal Representative or not, the manufacturer must appoint a licensed importer and designate it in writing. Registration documentation will not be accepted without an importer named.
IMPORTANT: The Colombian regulator may choose to audit your submission. INVIMA can also request additional documents.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Colombia.
Colombian medical device classification is rule-based. Determining the proper classification for your medical device might be challenging. And it is critical to ensure a smooth registration process. We have many years' experience with Colombia medical device classification.
Companies without presence in Colombia are required to appoint an Importer and should name it in their registration documentation. Also, it is recommended to manage all registration processes in Colombia with the help of a Legal Representative as an in-country liaison with INVIMA. Having an independent firm controlling registration processes is a big advantage. We will help you find an Importer and a reliable Colombia Legal Representative.
Correctly prepared documentation will become the basis of a successful medical device registration in Colombia. MDRC will prepare your documentation in accordance with INVIMA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Colombian regulations.
If you do not have QMS certificates acknowledged by INVIMA, our consultants will advise you on what modifications must be made to your existing quality system to prepare for the INVIMA inspection. MDRC is also available to conduct preassessment audits to ensure that you, or your major suppliers, are ready for the audits. Internal auditor training is also available.
While your registration is being finalized, our distribution specialists can help you find and evaluate distributors in Colombia. This will increase the chances of finding a partner who is qualified and able to effectively market your products.
| Validity | 10 years |
| Language | Documents and Labeling must be in Spanish |
| Postmarket Surveillance | Adverse events and device recalls must be reported. |
| Expected Time | Class I and class IIa devices can be marketed after submission. The review of class IIb and III submissions normally takes 4-7 months . |
*You can assign the function of the Legal Representative in Colombia to the Importer. In this case your Importer will control the registration process and own your registration certificates. To keep the registration under control companies appoint an independent Legal Representative. However, irrespective of whether the registration is managed by a Colombian Legal Representative or not, the manufacturer must appoint a licensed importer and designate it in writing. Registration documentation will not be accepted without an importer named.
IMPORTANT: The Colombian regulator may choose to audit your submission. INVIMA can also request additional documents.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Colombia.
Colombian medical device classification is rule-based. Determining the proper classification for your medical device might be challenging. And it is critical to ensure a smooth registration process. We have many years' experience with Colombia medical device classification.
Companies without presence in Colombia are required to appoint an Importer and should name it in their registration documentation. Also, it is recommended to manage all registration processes in Colombia with the help of a Legal Representative as an in-country liaison with INVIMA. Having an independent firm controlling registration processes is a big advantage. We will help you find an Importer and a reliable Colombia Legal Representative.
Correctly prepared documentation will become the basis of a successful medical device registration in Colombia. MDRC will prepare your documentation in accordance with INVIMA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Colombian regulations.
If you do not have QMS certificates acknowledged by INVIMA, our consultants will advise you on what modifications must be made to your existing quality system to prepare for the INVIMA inspection. MDRC is also available to conduct preassessment audits to ensure that you, or your major suppliers, are ready for the audits. Internal auditor training is also available.
While your registration is being finalized, our distribution specialists can help you find and evaluate distributors in Colombia. This will increase the chances of finding a partner who is qualified and able to effectively market your products.
