Medical Devices

We advise on Sanitary Registration procedures and permits related to products such as:

Tomography equipment, X-rays, probes, catheters, pressure gauges, syringe, thermometers, scales, diapers, female sanitary pads, hospital grade disinfectants, aesthetic prosthesis, prosthetic joints, prophylactic, clinical diagnostic reagents, bioanalytical equipment, Intrauterine Devices (IUDs), toilet paper and much more.

 

Technical and legal requirements for the registration of medical equipment and supplies, paramedical and related*

• Sanitary registration of the importer company, must be updated.
• Certificate of free sale: issued by the health authority or local health office, legalized  by consulate or notarized, must be updated.
• Certificate of good manufacturing practice or also manufacturer’s production capability, issued by authorized agency, legalized by the consulate or notarized.
• Power of Attorney (POA) of distribution from the manufacturer / owner to the national company, to “import, market and register” their products, should be legalized at the consulate or notarized.
• Composition of the products or equipments: types and varieties or sizes within the group.
• Prospects or inserts with information of the usage of the product.
• Certificate of analysis that verifies the quality, conducted on a batch or lot, should contain specifications and results of all the parameters evaluated. Original form and Signed.
• Catalogs: promotional materials in Spanish that explains benefits and technical features.
• Samples: in commercial presentation, by type and size for a national laboratory evaluation, if the product is required for this control.
• Professional Representation and sponsorship Power of Attorney (POA): Awarded by the national company for the pharmaceutical Sponsor.

*(Indicative only)