RAUpdate Reform to the Regulations for Health Supplies (RIS): Validity extension for Medical Devices
The Federal Commission for Protection against Sanitary Risks (COFEPRIS), through the Official Gazette of the Federation (DOF), updated some articles of its Regulations for Health Supplies (RIS, its acronym in Spanish), which helps to improve and reduce processing times.
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Decree reforming and adding various provisions to the Health Supplies Regulations Published 24/04/2026
Update
The purpose of these reforms is to align Mexican regulations with international industrial property commitments (such as those derived from the USMCA) and to streamline the regulation of health supplies, ensuring a balance between protecting innovation and access to medicines.
For medical devices, the Article 190 Bis 3, establishes that to obtain the first renewal of the sanitary registration of medical devices that are nationally manufactured, the authorization will be granted for a period of ten years, in accordance with the provisions of article 376 of the General Health Law (LGS).
Article 190 Bis 7, establishes that holders of the health registrations, provided for in the previous article of this regulation, in order to obtain their second and subsequent renewals, must submit to the authority, every ten years in accordance with the provisions of article 376 of the Law, and no later than one hundred and fifty calendar days before the date on which the validity concludes, the corresponding application, using the forms that said authority issues for this purpose.
This reform responds to the reform of the LGS of January 2026 in article 376 which stipulates that the renewals remain for 10 years.
The transitional regime of this update establishes that the Decree becomes effective on the day following its publication in the Official Gazette of the Federation. Regarding matters in progress, those applications for registration or renewal submitted prior to the entry into force of this decree will be governed and processed until their final conclusion according to the provisions in effect at the time of their initial filing. Finally, concerning supplementarity, it is determined that previous provisions will continue to be applied while the necessary regulatory and administrative adjustments are made, provided that they do not contradict what is established in the new decree; in cases of conflict, the competent authority must directly apply the new provisions.
Note: the Decree does not include foreign-made medical devices, so it is expected that these will be included in the coming months.
Regulatory Framework
This Decree is grounded in, and has implications for, the following regulatory instruments:
General Health Law (Ley General de Salud)
Regulation for Health Supplies (Reglamento de Insumos para la Salud)
Effects from RAUpdate
The update to the RIS generates direct effects on the strategic planning of medical device companies:
Administrative burden simplification: By doubling the validity period of renewals from five to ten years, the frequency of interaction with the health authority for continuity procedures is reduced. This allows for more stable product portfolio management and reduces the operational costs associated with preparing renewal dossiers.
Compliance scenarios companies: Currently holding sanitary registrations nearing expiration must evaluate their application date. If the procedure is already in progress, previous conditions will be maintained. However, for new renewal applications, the focus must center on strict compliance with official formats and the 150-day deadline prior to expiration to ensure the granting of the ten-year period.
Impact on nationally manufactured supplies: The emphasis of Article 190 Bis 3 on nationally manufactured supplies suggests a direct benefit for the industry established in Mexican territory, facilitating its permanence in the market through longer-duration authorizations.
Written By:
Sandra Miguel
Medical Device Regulatory Affairs Analyst with 4+ years of experience in national and international regulation, having collaborated with global teams for successful submissions of Class I, II, and III medical devices; ensuring regulatory compliance and providing strategic guidance to facilitate product commercialization in Mexico.
About IPS
IPS specializes in providing strategic regulatory intelligence and hands-on support. We can help you analyze the impact of this new decree on your products, ensure renewals on time
Contact us at info@insumosparasalud.com for more information regarding our specialized services.