In Vitro Diagnostic Devices (Category II and IIl)

Regulatory Roadmap

Submission Method

Applications for registration can be submitted online.

Type of Market Approval

Category I and Il IVDs are eligible for automatic registration. Category Ill IVDs are subject to pre-market approval.

Roadmap by Category

Category Ill

The registration process for pre-market approval of category Ill IVDs will require the following steps:

1. Appoint a local representative through a power of attorney.

2. If IVD has no valid certificate of free sale (CFS) from recognized reference countries, obtain technical approval from the Specialized Board, according to the requirements in Article 7 of Decree 3770/2004.

3. Ensure documents provided by the manufacturer are compliant with INVIMA requirements.

4. Compile the technical submission in Spanish (or at least Spanish summaries of test reports).

5. Provide product certifications and manufacturer's testing methodology.

6. File the application with INVIMA.

7. Answer any questions that INVIMA may ask regarding the application (responses must be submitted within 90 working days of the request).

8. Make any legal and technical revisions of the application, if required by INVIMA.

9. Upon approval, begin marketing.

10. Maintain post-market obligations.

Technical Documentation

Dossier Requirements

Category l, Il, and Ill

The following documentation is required for registration submissions for all IVDs:      

1. A Power of Attorney in favor of the applicant for registration (if third-party is used for application), which must be Apostilled or legalized up to a Colombian consul in the country of origin.      

2. Letter of authorization to the importer(s), on company letterhead, signed by a person responsible for the manufacturing of the product within the company.      

3. Duly completed application form, including:

   1. Name of the product.

   2. Name of the manufacturer and importer.

   3. Application and use of the device.

   4. Components.

   5. Kit content.

   6. Additional needed materials.

   7. Trademark certificate issued by the Trademark Office.

   8. Authorization of use of the trademark if the same is already registered.

4. Certificate of free sale (CFS) from the country of origin, or acceptable reference countries (EU, US, Canada, Japan, and Australia, or countries where there is mutual recognition agreement in force with Colombia); apostilled or legalized by a Colombian Consul from the country of origin.      

5. Certificates of Analysis (sensitivity, specificity, reproducibility).

6. Stability studies.

7. Insert.

8. Labels.

9. Quality Management System (QMS) Certificate.

Standards

Testing to international standards is generally accepted by INVIMA.

Clinical Data

Clinical performance data from other countries are generally accepted by INVIMA.

INVIMA clarifies the expected methodological design quality of the clinical studies to be submitted with the IVD technical dossier in Act No. 10 from 13 November 2019. This document states that clinical studies should be:

1. Performed on human beings to demonstrate safety and effectiveness.

2. Published in a magazine or scientific journal (periodical research publication that is of high quality, listed in a database of the global consultation, and that requires specialized methodological and technical evaluation for publication).

3. Submitted clinical data can be of similar or equivalent technologies to the one presented in the application of health registrations and can be up to 10 years from the issuance date.

Testing (local)

Local testing for category I and Il IVDs is not required. For category Ill IVDs without a valid CFS from a recognized reference country, the Specialized Board may require samples for local testing.

Labeling

Requirements

Labeling of IVDs is addressed in Article 25 of Decree 3770/2004. The labeling of the primary container of the IVD should contain:      

• Product name.

• Name of the manufacturer and importer.

• Lot number.

• Expiration date.

• Composition.

• Intended use.

• Conditions for storage.

• Precautions.

• Registration number.

Requirements for the Insert to be included with IVDs are listed in Article 10.1.1 of Decree 3770/2004. The Insert must provide a clear indication of the proper use and storage Of the IVD. Imported IVDS can be labeled in the language of the country of origin; however, the Insert must be provided in Spanish.

E-Labeling

E-labeling is not permitted in Colombia.

Advertising

Regulations for advertising of IVD reagents are addressed in Articles 29 and 30 of Decree 3770/2004. Only registered IVDs can be advertised in Colombia, and the advertisement cannot make any claims beyond what is included in the registration.

Quality Management System

Manufacturers are required to have valid QMS certification. Foreign manufacturers must submit a valid QMS certificate issued by a recognized national or international entity as part of the registration application. INVIMA does not require certification to any particular QMS standards, but, in practice, most manufacturers provide their ISO 13485 certificate, which is INVIMA's general expectation.

Cost

Registration fees are listed on the INVIMA website.

Category Ill

The fee to register a category Ill IVD is COP $2,340,805.

If approval by the Specialized Board for IVDs is required, an additional fee of COP $3,272,640 will apply.

Time-to-Market

Category Ill

The official timeline for the review of category Ill IVD applications is 90 working days. In Emergo's experience, approval is typically obtained within 4—6 months after submission. For category Ill IVDs that require approval by the Specialized Board, the approval process can take up to 4 months from submission, followed by the additional 4-6 months for product registration.