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Policies

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Submitted By aidanbocardo
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Direct Government Policy
The main barrier to commercialization entry is that the technology must be approved by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) rules and regulations in order to enter the national market.

The Health and Economy Departments published in the Official Gazette the agreement which is recognized as equivalent to the requirements and procedures for requesting the Federal Commission for the protection against health hazards (COFEPRIS) to emit the registration of medical devices, with requirements that establish health agencies of the United States and Canada1.
This decision of the Government of Mexico is aimed at enabling the Mexicans as quickly as possible to the medical equipment of last generation that are sold worldwide access.

The Faculty of the Health Department to emit equivalence agreements is provided in article 161 of the Regulation of Health Supplies and will be more expeditious the entry into the Mexican medical devices market while maintaining the same level of quality, safety and efficacy that guarantees the COFEPRIS because the Mexican health authority not only review the medical devices have been evaluated and approved, in this case, by the health authorities Canadian (Health Canada) and American (FDA), it will verify the results of inspections and the documentation for manufacturing plants.

The Article 194 of the General Law of Health establish2: "For the purposes of this Law, are considered as health devices: The medicine, psychotropic substances, narcotics and raw materials and additives involved in its development; as well as medical equipment, prosthesis, orthesis, functional aids, diagnosis agents, devices for deontological use, surgical material, healing and personal hygiene products, those last in terms of the fraction VI of article 262 of this law; while article 195 of the same law provides: "The Health Department emit the Mexican official standards to which the process and the specifications of the products referred to in this title shall hold. Drugs are normed by the pharmacopeia of the Mexican United States"; Article 204 defines "The medicines and other health supplies … for sale or supply must have sanitary authorization …"

Article 376, "Require Health registration: drugs, narcotics, psychotropic substances and products containing them, medical equipment, prosthesis, orthesis, functional aids, diagnosis agents, devices for deontological use, surgical material, healing and personal hygiene products”

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