Medical Device Registration in Colombia

GENERAL ADMINISTRATIVE INFORMATION FOR MEDICAL DEVICE REGISTRATION IN COLOMBIA

1. Power duly given to Authorized Rep office accompanied by notarized statement. Must be legalized through consulate or apostille. (Spanish)

2. Authorization letter addressed to the importer(s), in company letter head, including importers data, signed by responsible person (model available – LOA) (Spanish)

3. Ownership authorization (if applicable). In company letterhead, including owner company data, signed by responsible (it can be done in the same LOA) (Spanish)

4. Free Sales Certificate (FSC) or CFG issued by the competent sanitary agency in the country of origin or a reference country (Canada, Japan, Australia, European Union, USA). Must be legalized through consulate or apostille. This document must provide the following information:
 Indicate the name, brands, references, models of all of the products
 Indicate all manufacturers (original and legal, when apply). Name must be the same as technical documents
 Indicate that the product has been authorized for production and/or commercialization in the country of origin.
 The above will be valid for one (1) year from issuing date; nevertheless, the date given by the sanitary authority is valid.
 Must be officially translated to Spanish language (in Colombia)

5. Importer´s documents:
 Certificate of Conditioning and storing capability conditions (CCAA), issued by INVIMA, valid, and applicable to the class of MD/EBC to import
 Business license certification (less than one month older)

GENERAL TECHNICAL INFORMATION FOR MEDICAL DEVICE REGISTRATION IN COLOMBIA

For Medical devices and/or equipment classified I, IIa, IIb or III:

1. The description of the medical device must have the following basic information (required in Spanish)
 Generic name and/or brand (preferably identical to those included in CFS/CFG)
 Classification risk / standard/ rule
 International code (UMDNS, GMDN, UDI or similarly recognized).
 Uses and indications.
 List of the main parts / components and/or when applicable, its composition.
 Contraindications, warnings and precautionary statements.
 Commercial presentation (sales unit / format).
 List of references (code/model – Family – Description).
 Accessories.
 Patient interaction, specifications, operation and description of operation.
 Shelf life.
 For Biomedical Equipment, indicate type of system: ELECTRICAL, ELECTRONIC, ELECTROMECHANICAL, HYDRAULIC, MECHANICAL, PNEUMATIC
 For Biomedical Equipment, indicate type equipment: for DIAGNOSIS, TREATMENT, LIFE SUPPORT, SOFTWARE, REHABILITATION, ASSISTANCE

2. Technical study and validation (*): (Spanish)
 Summary of the design verification and validation documents (test reports during manufacturing process). In the case of biomedical equipment, the documentation must establish that the design meets the current standards and rulings specific to these.
 Certificate of analysis of the finished product containing the specifications, indicating the values or acceptance ranges (must fulfil with norms and technical standards specific for the product)

3. Declaration of conformity issued by the manufacturer where the requirements of the referenced international standards are met, and the name of the device / equipment is clearly stated (Spanish)

4. Sterilization method when applicable (*). In all cases provide certificate of analysis, method, results and conclusions. In case of ETO sterilization attach studies of ethylene oxide residues. (Spanish – summary)

5. Method of final disposal of the product (*). A certification issued by the manufacturer or authorized importer is accepted along with the manual or insert specifying the method for the final disposal of the product or the application of local regulations (available model). (Spanish)

6. Shelf life (When applicable) (Spanish- summary)
 For accessories or sterile medical devices from the factory or non-sterile products that declare useful life, this requirement is met by attaching the stability studies that allow to validate the attributed shelf life, attaching summary of the method, verification, validation and final result.
 In the case of products that do not declare the shelf life, the manufacturer’s declaration will not be required.
 For biomedical equipment, declaration issued by the manufacturer certifying the shelf life of the equipment

7. Declaration stating that operation and maintenance manuals are available in Spanish and will be submitted to the user, for equipment’s class I and IIa (model available) (Spanish)

8. Final arts of the labels and inserts (when applicable) of the manufacturer in which it is evidenced as a minimum:
 Name of the product or reference, name and address of the manufacturer and internationally recognized safety symbols.
 Label of the importer where indicated: name of the product, model and / or reference, name and address of the importer, number of Sanitary Registry
 To include “FREE SAMPLES”, provide the tag label with the observation. These samples only apply to health professionals

9. Commercial history of the device referencing countries where the device is marketed, and a declaration of health alerts and serious events involved with the device and corrective actions related to them. If events have occurred, closure support from other authorities is required. Issued by manufacturer. (Spanish)

10. Declaration issued by the manufacturer stating the name that the product will have in Colombia, if applicable (model available). (Spanish)

11. List of international standards used/applicable (Spanish – summary)