Proyecto de Norma Oficial Mexicana PROY-NOM-240-SSA1-2024 Instalación y operación de la tecnovigilancia (Draft Mexican Official Standard PROY-NOM-240-SSA1-2024: Introduction and operation of technovigilance) (18 pages, in Spanish)

Protection of human health or safety (TBT)

Applicable to technovigilance that ensures that medical devices are safe, effective and perform according to the manufacturer's specifications.

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Human health

• The purpose of technovigilance is to ensure that medical devices in use on the market in the national territory are safe, effective and perform according to the manufacturer's specifications, authorized by the Ministry of Health through the Federal Commission for Protection against Health Risks. • The purpose of draft Mexican Official Standard PROY-NOM-240 is to establish guidelines for the introduction and operation of technovigilance in order to guarantee the protection of patient health and the safety of medical devices in use in the national territory. • The notified draft Standard is binding throughout the national territory on federal and local government agencies and entities, natural or legal persons in the social and private sectors that are part of the National Health System, institutions and establishments where human health research is conducted, health professionals, patients and users, holders of sanitary registration certificates or their legal G/TBT/N/MEX/536 - 2 - representatives in Mexico, manufacturers, distributors and marketers of medical devices and those involved in the medical device supply chain.

1:File here 2:File here

EN:File here

FR:File here

ES:File here

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