El Salvador | Technical Regulation RTS 11.03.03:22 MEDICAL DEVICES. GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICES AND ITS VERIFICATION GUIDE

Title of document
Reglamento Técnico Salvadoreño RTS 11.03.03:22 DISPOSITIVOS MÉDICOS. BUENAS PRÁCTICAS DE MANUFACTURA DE DISPOSITIVOS MÉDICOS Y SU GUÍA DE VERIFICACIÓN. (89 page(s), in Spanish)

Description
This regulation establishes the principles and guidelines of the Good Manufacturing Practices, which regulate all the procedures involved in the manufacture of medical devices, in order to ensure their efficacy, safety and quality.

Notifying member: El Salvador

Notification: G/TBT/N/SLV/219

Objective tag
Prevention of deceptive practices and consumer protection; Protection of human health or safety

Documents

• 22_1105_00_s.pdf

Agency responsible
Organismo Salvadoreño de Reglamentación Técnica (OSARTEC).

Timing:

• Submission: 28/01/2022
• Reception: 28/01/2022
• Distribution: 31/01/2022
• Final date for comments: 01/04/2022
• Proposed date of adoption: N/A