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Inter Institutional Formulary Product Registration Requirements – English
Distromex is dedicated to Mexico's Health Care improvements for it patients and Hospitals. To carry out this activity, we analyze the needs of the Mexican National Institutions of Public Health. As we work together to determine the selection of products we wish to commercialize in Mexico, greater sales can be accomplished if we can add the products to the Inter institutional formulary called the CUADRO BASICO.
It is the Council of General Health that publishes what the Institutions could buy without any risk. By virtue of which the product is scientifically proven by Mexican experts of diverse institutions (ISSSTE, IMSS AND DIFFERENT UNIVERSITIES), that it is an economic benefit to the country as well as for its technical advance to what already exists.
Mexico emits the laws under which the products can be imported, distributed and commercialized inside its territory. The requirements will depend on the product itself; nevertheless, the general requirements are needed in Spanish. If it is not possible, please notify us so we may discuss an alternative way to translate.
Please provide Distromex with a letter to import and distribute your companies products. Include the list of products and Certified and or notarized the document in Spanish.
Additionally, please include the following information for each product in Spanish if possible. This specific data will benefit your company because it describes your specific products to be sold in the inter-institutional formulary.
| 1. Specific product name |
| 2. Commercial name, commercial brand name or secondary name |
| 3. Common International denomination, scientific name or generic name |
| 4. Products physical formation (solid, liquid or gas) |
| 5. Product description and product size |
| 6. Technical and scientific Information proving that the product is safe and efficient. |
| A. Quantitative and Qualitative chemical formulation |
| B. Sterility test and certificate |
| C. Investigation protocol |
| D. Characteristic description of primary and secondary packing materials with citoxitity test. |
| 7. User manual |
| A. Specific use of product |
| B. Accessories and characteristics of its operation i.e. if product is an accessory, what is used with it. |
| Or if product is an instrument, what accessories are used with it? |
| 8. Description of the products structure, materials, physical characteristics and functions. |
| 9. Laboratory studies of the physical, mechanic and chemical specifications of the product. |
| 10. Conditions of storage and product shelf life, and or Stability test using 3 different lots and 3 different temperatures |
| 11. Microbiological test |
| 12. Product Citoxitity or Bio compatibility test |
| 13. Bibliographical product publications or medical reference journals |
| 14. Notarized Certificate of sale |
| 15. FDA certificate of product |
| 16. Products 510 K |
| 17. Cost benefit analysis of products |
| 18. Four color catalog of specific products in Spanish |
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