Regulatory registration of medical devices in Colombia.
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 product registration dossier file and 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.
This offering includes,
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 document requirements.
Preparation and submission of the final dossier file to INVIMA.
Answering post-submission follow-up questions from the INVIMA reviewer.
Class I: 2,699
Class IIa: 3,499
Class IIb: 5,499
Class III: 7,799
Submission and registration
The following steps will be conducted in order to obtain the registration of your medical product:
Review of initial device information (intended use and claims) to verify the classification.
According to product classification, we will provide an applicable list of requirements for registration.
Preparation of the registration documentation after receiving the registration information from you.
Assist and coordinate translations as needed.
Deliver the technical file to INVIMA.
Assist with any post-submission follow-up questions from the INVIMA reviewer.
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.
Drugs: 6-12 months.
Dietary supplements: 90 days.
Food: 90 days.
Cosmetics: Automatic/immediate upon submission/notification.
Alcoholic beverages: 30 days.
Personal hygiene: Automatic/immediate upon submission/notification.
Medical devices: 10 years
Drugs: 5 years
Dietary supplements: 10 years
Food: 10 years (low risk), 7 years (medium risk), 3 years (high risk)
Cosmetics: 7 years
Alcoholic beverages: 10 years
Personal hygiene: 5 years
Notes (*): 50% payable upon receipt of invoice, and remaining 50% payable upon submission to INVIMA. If your product already has marketing authorization from a reference country (i.e., GHTF founding-member countries: US, EU, Canada, Australia or Japan), INVIMA will approve your product faster. For medical devices, pricing 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. Includes one (1) registration certificate (family of SKUs that can be consolidated in one certificate). Colombian regulations require INVIMA applications to include the name of your IOR in Colombia. If you plan to have one distributor in Colombia, then your distributor will likely be your IOR. If you plan to have two or more distributors, then very likely you will name a third-party independent logistics operator as your IOR. Translations are not included and will be charged separately. Our pricing model is based on the fact that the pending product has already been approved in another major reference country that has a governing regulating body that approves or denies new product. If a new INVIMA-regulated product does not have any approvals in a reference country, the cost of the INVIMA approval process will increase substantially as the manufacturer will now have to conduct numerous new product tests as applicable for usage, performance, safety, sterilization, bio-compatibility, electrical, and technical.
INVIMA Regulatory Registration and Approval in Colombia
*Source: INVIMA (in Spanish).
This offering excludes:
INVIMA fees (USD): Medical devices: 850-1,000 (depending on the classification). Drugs: 1,200 to 14,000 depending on the type of drug and whether your product has FDA or EMA marketing authorization or not. Food: 2,000. Cosmetics: 800. Personal hygiene: 500. Nutritional supplements: 1,500. These fees are valid until december 2018 and are approximated due to exchange rate fluctuations.
Simple document translations to Spanish. bioaccess.™ can translate these documents and will invoiced you at USD 0.25 per word in Spanish.
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).
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.