Since the 1st of June 2021 amendments to the Health Supplies Regulation (Reglamento de Insumos para la Salud RIS, which also includes the regulations for Medical Devices) have come into effect in order to eliminate bureaucratic redundancy, to optimise the processes required for quality management and to strengthen the role of post-market surveillance.
The changes have been officialized with the publication of the decree of reference, Decreto por el que se reforman, adicionan y derogan diversas disposiciones del Reglamento de Insumos para la Salud, on the Official federal Journal (Diario Oficial de la Federación – DOF) last May 31 2021.
What are the most significant changes?
- Elimination of the obligation to translate into Spanish. The Mexican Regulatory Authority Cofepris (Comisión Federal para la Protección contra Riesgos Sanitarios) removes the obligation of sending documents only in Spanish, accepting them also in English, in order to reduce the time and cost of third-party translations.
- Changes applied to the process of renewing registrations. Prior to these changes, any registration had to be renewed every 5 years. Now, after 5 years, if your registration is renewed, you don’t need to submit further renewals unless there are safety issues with the product. This simplifies the administrative process, reduces renewal costs and reduces the regulatory burden.
Do you want to market your Medical Devices in Mexico?
Choose Thema as your consultant. Check out the Country Profile Medical Device Registration in Mexico to have a general overview of the registration procedure.
Through a wide range of strategic-regulatory consulting services we can support you during the registration process to properly market your Medical Device in the Mexican market.
Contact us for more information!
Comisión Federal para la Protección contra Riesgos Sanitarios – Cofepris
Cofepris, Comunicado a la poblacion 17/2021, 1 June 2021
DECRETO por el que se reforman, adicionan y derogan diversas disposiciones del Reglamento de Insumos para la Salud, Diario Oficial de la Federación (DOF), 31 May 2021