Colombia medical device approval chart - Emergo

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Easy to understand chart describes the medical device registration process with INVIMA in Colombia.

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Colombia medical device approval chart - Emergo

  1. 1. Colombia © 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 10/2016. EmergoGroup.com/Colombia Medical devices are governed by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). Determine classification of your medical device according to Chapter II of Decree 4725/2005. If you have no local presence in Colombia, appoint a qualified Importer or Colombia Legal Representative who will submit your registrations to INVIMA. If you appoint an Importer they may list themselves as the owner of the registration. If you appoint a Legal Representative, they will manage your registration process, but you will retain ownership.* Provide test reports for Class IIa, IIb, and III devices. Provide clinical data for Class IIb and III devices. Provide a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) to demonstrate that your device can be legally sold in your home market or Australia, Canada, the European Union, Japan or the US. Class IIaClass I Class IIb Class III Your Importer or Colombia Legal Representative submits your application dossier to INVIMA and manages your medical device registration in Colombia. Documents must be submitted in Spanish. Pay application fee to INVIMA. Provide proof of quality system compliance, such as an ISO 13485 certificate or proof of FDA QSR compliance. Prepare registration application dossier including detailed device information. Once approved, INVIMA will issue the registration certificate. Your registration certificate will be held by your Legal Representative or Importer in Colombia. 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. You may begin marketing your device in Colombia. Registrations are valid for 10 years. Once INVIMA receives your application for renewal, your registration will be automatically renewed. 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. You may begin marketing your device in Colombia. Registrations are valid for 10 years. Application renewals are due to INVIMA three months before the expiration of your registration certificate. 5163-1016 The Regulatory Process for Medical Devices *Companies may appoint a Legal Representative in order to maintain control of the registration. However, irrespective of whether the registration is submitted via Legal Representative or not, the manufacturer must appoint a licensed importer in the registration. Registrations will not be accepted without a valid importer named. This is a simplified overview of the process. INVIMA may choose to audit your submission and request more documents, which will add time to your approval.
  2. 2. Colombia Notes 1. The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation and how much time you take to address additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE. 2. Registrations remain valid for the time specified as long as you do not make changes to the device, intended use or indications for use. 3. Renewal documents are due to INVIMA three months prior to the expiration of the current registration certificate. We recommend starting the re- registration process no later than the time period specified above. However, please consult with your distributor or regulatory expert well before this suggested time to avoid any lapse in your registration. 4. Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who were asked to rate the difficulty of registering a device in each country. The European CE Marking process is considered the mid-point to which all other markets are compared. 5. Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing, in-country representation, submission preparation consulting and translation of registration documents but not IFU. Costs assume you already have approval for your device in the United States, Europe, Canada or Japan. Does not include cost of implementing or auditing a quality management system compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable. EmergoGroup.com/Colombia Device classification in Colombia  Class I Class IIa Class IIb Class III How long you should expect to wait after submission until approval is granted.1 < 1 month < 1 month 4-6 months 4-6 months Validity period for device registrations.2 10 years 10 years 10 years 10 years Registration renewal should be started this far in advance.3 3 months 3 months 9 months 9 months Complexity of the registration process for this classification.4 Overall cost of gaining regulatory approval.5 5163-1016 © 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 10/2016. Time, Cost, and Complexity of Registration Simple Complex Simple Complex Simple Complex Simple Complex Low High Low High Low High Low High This is a simplified overview of the process. INVIMA may choose to audit your submission and request more documents, which will add time to your approval.

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