INVIMA Medical Device Regulatory Registration in Colombia

Medical device Invima regulatory registration in Colombia

INVIMA Medical Device Regulatory Registration in Colombia

from $2,699.00

Obtain marketing authorization and sell your medical device in Colombia now. Register your medical device under your company's name. Retain ownership, control, and maintain independence from local distributors.

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INVIMA Regulatory Registration and Marketing Authorization in Colombia for FDA/EU-approved Medical Devices

Before foreign manufacturers can legally sell their regulated products 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 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,

  1. One registration certificate (family of SKUs that can be consolidated in one certificate).
  2. Unlimited regulatory and business strategy sessions with you.
  3. Review of your market readiness (i.e., distributor partner program, contract, website, marketing material) and recommendations to successfully enter the market.
  4. Review of documentation, gap analysis and classification of your product.
  5. Assistance with the search and selection of an INVIMA-certified importer of record (IOR)*.
  6. Assistance with document translations to Spanish*.
  7. 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*.
  8. 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.
  9. Preparation and submission of the final dossier file to INVIMA.
  10. Answering post-submission follow-up questions from the INVIMA reviewer.
“It is strongly recommended that U.S. companies process the registration under their name and not under the local distributor’s name or else the U.S. company will not be able to change or add distributors during the lifetime of the registration, which is 10 years.”
— US Department of Commerce, Export.gov

Timeline

  • Assembly of dossier file: Approx. 30-45 days after receipt of documents.

  • Submission, follow up, and approval of registration by INVIMA (approx. times).

    • Medical devices: 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.

Exclusions

This offering excludes:

  1. INVIMA fees (USD): Medical devices: 850-1,000 (depending on the classification). INVIMA fees are valid until December 2018 and are rounded-up due to exchange rate fluctuations. 

  2. Simple document translations to Spanish. bioaccess.™ can translate these documents and will invoice you at USD 0.25 per word in Spanish. 
  3. Documents which must be notarized/apostilled such as your certificate of free sale/certificate to foreign government and letter of representation.
  4. INVIMA visit to a foreign manufacturing plant (if applicable).
  5. Biological/biotechnology/biopharmaceutical drugs.
  6. Search and selection of a distributor or IOR in Colombia.
  7. Transfer of an existing INVIMA product registration certificate from an entity in Colombia to your company's name.
  8. Medical devices that are not approved for sale at a reference country (i.e., GHTF founding-member countries: US, EU, Canada, Australia or Japan).