INVIMA Medical Device & IVD Regulatory Registration in Colombia
Obtain marketing clearance and sell your medical device or IVD product in Colombia now. Register your medical device under your company's name at INVIMA. Retain ownership, control, and maintain independence from local distributors.
Before foreign manufacturers can legally sell their medical devices in Colombia, they must be in compliance with Colombian health regulations and registration requirements. Food, medical device, drugs, dietary supplements and cosmetic products in Colombia are regulated by the National Institute for Medications and Food Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or INVIMA).
We can become your authorized/registered agent/legal representative in Colombia and assist with the preparation and submission of your medical device registration dossier file/application to INVIMA. We will compile your technical and legal file, will review all labeling for compliance, and will provide post-submission assistance with INVIMA all the way through the approval of the device registration. The validity of your marketing authorization to sell your medical device in Colombia will be for 10 years.
This offering includes,
The possibility of having us as your regulatory, administrative, and commercial agent in Colombia.*
One registration certificate (family of SKUs that can be consolidated in one certificate).
Unlimited regulatory and business strategy sessions with you.
Review of your market readiness (i.e., distributor partner program, contract, website, marketing material) and recommendations to successfully enter the market.
Review of documentation, gap analysis and classification of your product.
Assistance with the search and selection of an INVIMA-certified importer of record (IOR).*
Assistance with document translations to Spanish.*
When applicable, we will assist you with transferring to your company's name any existing registration that a local distributor may have secured in Colombia for your product.*
If needed in special cases, we will send INVIMA a formal petition letter to seek the agency's opinion on product classification or specific documentation requirements.
Preparation and submission of the final dossier file to INVIMA.
Answering post-submission follow-up questions from the INVIMA reviewer.
(*) See exclusions.
Class I: 2,999
Class IIa: 3,999
Class IIb: 5,999
Class III: 8,999
Assembly of dossier file: Approx. 30-45 days after receipt of technical and legal documents.
Submission, follow up, and approval of registration by INVIMA (approx. times):
Class IIb and III device applications must first be reviewed and approved by INVIMA prior to being placed onto the market, which on average takes 3-6 months (approx.), depending on INVIMA’s current review times. INVIMA automatically approves Class I and Class IIa devices but it may take about eight (8) days to issue the registration certificate.
Upon acceptance of the Offer a) bioaccess.™ will invoice 50% of the listed fees and 50% upon completion.
This offering excludes:
INVIMA fees (USD): 600-1,000 (depending on the device classification).
Annual fees for authorized/registered agent/legal representation in Colombia.
Simple document translations to Spanish. bioaccess.™ can translate these documents and will invoice you at USD 0.25 per word in Spanish. The total cost of translating your technical and legal documents will depend on their page count.
Documents which must be notarized/apostilled such as your certificate of free sale/certificate to foreign government and letter of representation.
INVIMA visit to a foreign manufacturing plant (if applicable).
Market research, market access plan or search and selection of a distributor or IOR in Colombia.
Transfer of an existing INVIMA product registration certificate from an entity in Colombia to your company's name.
Note: INVIMA does not currently allow for the registration of medical devices that don’t have a certificate of free sale (CFS) from their country of manufacture or regulatory approval from a reference country (EU, USA, Canada, Japan and Australia).