I.INVIMA Introduction

In Colombia, the regulatory body that oversees medical devices is known as the National Institute for the Supervision of Medicines and Food (INVIMA). This institution was created by the Colombian Ministry of Health (MoH) and includes not only the supervision of medical devices, but also food, medicines and any other product that requires sanitary supervision.

II. Applicable Regulation

1. MD: Decree 4725/2005 (and its amendments)

2. IVD: Decree-Law 3770/2004 (and its amendments).

III. Medical Devices Classification

The classification of equipment in Colombia follows a four-level risk model (Class I, Class IIa, Class IIb and Class III), similar to the classification scheme used in Europe. In descending order, MD is categorized as Class I, IIa, IIb and III, and IVD is categorized as Class I, II and III. The classification rules followed are Decree 4725/2005.

IV. Medical Device Registration Information

INVIMA categorizes all medical devices from a regulatory point of view into uncontrolled and controlled, with different certification modalities for each classification: uncontrolled category I and lla devices are eligible for "automatic" registration. Controlled devices and Class IIb and III devices require premarket approval.

1. The following documents are required to submit registration documents for Class I and lla equipment:

Authorization letter of the registered applicant

Authorization to Importer

Certificate of free distribution stamped or notarized/legalized by the Colombian consulate in the country of origin

Application form

Copy of quality management system (QMS) certificate

Medical device descriptions (and other technical descriptions)

Technical research and analytical testing

Final labeling and instructions

If necessary, additional information for the evaluation of the safety of the medical device is provided upon request by INVIMA.

2. Class IIb or III

(1) Uncontrolled equipment

In addition to the above documentation, in the case of biomedical devices, the evidence should demonstrate that the design complies with applicable standards and codes.

If necessary, additional information for the evaluation of the safety of the medical device is provided upon request by INVIMA. Clinical studies demonstrate safety and efficacy of the devices.

Certificate of free sale (CFS) from the country of origin or an acceptable reference country (European Union, United States, Canada, Japan and Australia, or a country with which Colombia has a valid mutual recognition agreement)

(2) Controlled equipment

Applications for controlled equipment must include the following:

Certificates or proof of compliance with international quality standards (ISO 13485 certificates for manufacturers and all contract manufacturers).

Name and location of the health services lending institution, IPS, in which the equipment is to be installed, or commitment to report the equipment (if not yet commercialized)

Statements about the equipment issued by the manufacturer or a representative of Colombia

For INVIMA, it is important that IVD are somehow handled separately from medical devices. First, they are categorized into three different classes based on their risk level: Class III, Class II and Class I (high, medium and low risk, respectively). Class III IVD do require health registration to be manufactured, imported, exported, warehoused and sold in Colombia, unless they are commercialized in the United States, the European Union, Canada, Japan and Australia. Class II and Class I IVD also require automatic sanitary registration at the time of manufacture, import, export, warehousing and distribution in Colombia. Articles 10, 12 and 13 of Decree No. 3770 of 2004 detail the requirements and procedures for applying for this registration procedure. As with non-controlled technical biomedical devices in Class I and IIa, automatic registration will be issued a few days after submission, although INVIMA will continue to evaluate the information.

V. System Assessment

Class I and IIa: INVIMA allows for immediate approval. Manufacturers will still need to submit complete technical documentation to INVIMA for review, but INVIMA can immediately issue a certificate of registration and manufacturers can begin importing immediately. Once the formal review has begun, the manufacturer must respond to INVIMA's requests in a timely manner in order to maintain the validity of the registration. This was allowed in order to address the long review times and large backlogs of applications experienced by the Ministry of Health.

Class IIb and III: do not qualify for fast-track approval and must wait until the formal review and approval process is complete before marketing and sales can begin, usually within six to eight months of filing an application.

VI. Medical Device Registration Process in Colombia

1. Determine product classification

2. Appointed representative

3. Provide certificates

4. Provide quality system certification

5. Prepare registration documents

6. Submit materials and application fee

7. Registration Approval