MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
Baker McKenzie Edificio Virreyes Pedregal 24, 12th Floor Colonia Lomas Virreyes CP 11040 Mexico City Mexico
Tel: +52 55 4335 6419 Fax: +52 52 79 2999 Email: Adrian.Rodriguez-Montfort@bakermckenzie.com Web: www.bakermckenzie.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The legal framework regulating pharmaceuticals and medical devices is largely federal in Mexico, and includes the following laws and regulations: • the General Health Law (GHL); • the Health Supplies Secondary Regulations ( Regla- mento de Insumos para la Salud , or RIS); • the Health Services Secondary Regulations; • the Health Advertisement Secondary Regulations; • the Clinical Research Secondary Regulations (CRSR); and • several official Mexican standards on specific tech- nical aspects (eg, good manufacturing practices, labelling and stability). In Mexico, the legal and administrative nature of the Federal Commission for the Protection against Sani- tary Risks ( Comisión Federal para la Protección con- tra Riesgos Sanitarios , or COFEPRIS) is that of an autonomous agency, under the administrative struc- ture of the Ministry of Health (MoH). The GHL created COFEPRIS and gave it administrative, technical and operational autonomy. On 15 January 2026 a broad amendment to the GHL was published (the “Amendment”) which, among oth- er things, incorporates “digital health” into the GHL and introduces a dedicated chapter defining digi- tal health (including telehealth/telemedicine, mobile health, electronic health records and wearables). The
Amendment requires the MOH to issue implementing provisions and set baseline conditions for telehealth services, encompassing secure systems, protection of personal data and confidentiality, mechanisms to obtain informed consent and appropriate documenta- tion in respect of remote care. The Amendment does not develop further regulations or criteria for medtech or product-related digital health applications, includ- ing software as a medical device. 1.2 Challenging Decisions of Regulatory Bodies Decisions of the regulatory bodies that apply and enforce pharmaceutical and medical device regula- tions may be challenged through the following option- al appeal proceedings: • an initial administrative review, decided by the same authority that issued the appealed adminis- trative decision; • an annulment trial, decided by the Federal Admin- istrative Tribunal; and • an amparo trial, decided by a judicial body, a judge or a court (depending on the nature of the decision being challenged). The formal requirements for challenging a decision vary depending on the nature of the decision being challenged, but generally the appeal lawsuit will include: • identification of the affected party; • identification of the challenged decision;
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