Cases

Case: FOOD

STEPS TO FOLLOW FOR REGISTRATION OF AN IMPORTED FOOD ITEM OR A NATIONAL MANUFACTURED FOOD ITEM

1. Feasibility

Regulaffairs requests all the required technical documentation, a commercial presentation sample to conduct a food study, all the text on the labels and will adjust all the requirements. The product ingredients list will be verified regarding its controlled or limited components according to current National Regulations.

2. Samples Presentation

Samples presentation at the Official Laboratory. Expenses are requested, final legal and technical documentation to be able to present the samples to the official laboratory to be analyzed.

3. Documents Presentation to the Authorities

After obtaining satisfactory laboratory results, our team of specialists will compile a file with all the technical and legal documents and will submit the registration to the authorities or (Health Ministry).

4. Review by the Technical Unit

Review by the food hygiene management technical unit that will review the file and if everything is compliant will issue the product registration with a validity of 5 years.

5. Sanitary Registration Authorization

Signature by the Sanitary Control Service, delivery to the Representative

Case: COSMETIC

STEPS TO FOLLOW FOR REGISTRATION OF AN IMPORTED COSMETIC ITEM OR A NATIONAL MANUFACTURED COSMETIC ITEM

1. Feasibility

Regulaffairs requests all the required technical documentation, labels and packaging samples of each commercial presentation to review all the text and to adjust all the requirements. The product formula will be verified regarding its controlled or limited components according to current International Regulations.

2. Samples Presentation

Samples presentation at the Official Laboratory. Final legal and technical documentation is requested to be able to present the samples to the Health authority to be analyzed.

3. Documents Presentation to the Authorities

After obtaining satisfactory laboratory results, our team of specialists will compile a file with all the technical and legal documents and will submit the registration to the authorities.

4. Review by the Technical Unit

Review by the technical unit of the Cosmetics Department in the Drugs, Medicine and Cosmetics Management that will review the file and if everything is compliant will issue the product registration with a validity of 7 years.

5. Sanitary Registration Authorization

Signature by the Sanitary Control Service, delivery to the Representative.

6. Commercialization Notification

Once the product commercialization begins, health authority must be notified. Our team of specialists will compile a technical file and one digital file, and electronic appointment will be requested, product samples are subjected to analysis. A sample with the nationalized text will be presented to the authorities along with a constancy of sample analysis presentation.

Case: MEDICAL EQUIPMENT

STEPS TO FOLLOW FOR REGISTRATION OF AN IMPORTED OR A NATIONALLY MANUFACTURED MEDICAL EQUIPMENT OR MATERIAL

1. Feasibility

Regulaffairs requests all the required technical documentation and an illustrative catalog of each commercial presentation to review all the text and to adjust all the requirements. The equipment or material information will be verified regarding its controlled or limited components according to current International Regulations to be able to select the national evaluation agency, according to the type of material or equipment.

2. Samples Presentation

Samples presentation at the Official Laboratory. Final legal and technical documentation and samples are requested to be able to subject the material or equipment to a quality evaluation or documentation as applicable.

3. Documents Presentation to the Authorities

After obtaining satisfactory evaluation results, our team of specialists will compile a file with all the technical and legal documents and will submit the registration to the authorities.

4. Review by the Technical Unit

Review by the technical unit of the Medical, Paramedical and related Equipments and Materials Department that will review the file and if everything is compliant will issue the product registration with a validity of 5 years for nationally manufactured products and the same validity as the Certificate of Free Sale for the country of origin for imported products.

5. Sanitary Registration Authorization

Signature by the Sanitary Control Service, delivery to the Representative.

Case: PACKAGING AND CONTAINERS

STEPS TO FOLLOW FOR REGISTRATION OF AN IMPORTED OR A NATIONALLY MANUFACTURED MATERIAL CONTAINER FOR FOOD PACKAGING

1. Feasibility

Regulaffairs requests all the required technical documentation and a sample of each commercial presentation to conduct a study of type of material and to adjust all the requirements. The list of ingredients of the product will be verified regarding its controlled or limited components according to current national Regulations.

2. Documents Presentation to the Authorities

Final documentation will be requested and our team of specialists will compile a file with all the technical and legal documents and will submit the registration to the authorities of Food, Hygiene, Equipments and Containers Department.

3. Review by the Technical Unit

Review by the technical unit of the Edification, Equipments and Containers Department that will review the file and if everything is compliant will issue a Material analysis order.

4. File Compilation

Regulaffairs, through its team of specialists, will select an optimal evaluating agency and will coordinate the material delivery to be analyzed until satisfactory results are obtained. After obtaining such results, we will compile a file with all the technical and legal documents and will submit the registration to the authorities.

5. Review by the Technical Unit

Review by the technical unit of the Official Department in the Ministry that will review the file and if everything is compliant will issue a sanitary authorization with a validity of 5 years to the container material requested.

6. Sanitary Registration Authorization

Signature by the Sanitary Control Service, delivery to the Representative.