TBT BSN | Notification

Notification Detail :: G/TBT/N/MEX/534

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Proyecto de Norma Oficial Mexicana PROY-NOM-241-SSA1-2024, Buenas prácticas de fabricación de dispositivos médicos (Draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good manufacturing practices for medical devices) (78 pages, in Spanish)

Objective

Protection of human health or safety (TBT); Quality requirements (TBT)

Product Covered

All establishments involved in the manufacture of medical devices, warehouses for the packaging, storage and distribution of medical devices to be marketed or supplied in Mexico.

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Specific Regions

Description

Purpose • The purpose of the notified draft Standard is to set forth the minimum requirements for the design, development, manufacture, warehousing and distribution processes for medical devices for human use, based on their level of risk, that are to be marketed and made available in Mexican territory, so as to ensure their consistent compliance with quality, safety and performance requirements for use by the end consumer or patient. • The notified regulation also establishes the quality management and quality risk management system and provides for the design and development of medical devices, specifications for facilities and equipment, manufacturing systems, the control of inputs and specifications for quality control laboratories, among other considerations for applying good manufacturing practices. G/TBT/N/MEX/534 - 2 -   Scope • This Standard is binding in Mexican territory on all establishments engaged in the manufacture of medical devices and on warehouses that package, store and distribute medical devices to be marketed or supplied in Mexico.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/MEX/534

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