MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
These kinds of databases are not subject to authorisa- tion before operations commence.
bolic mechanisms; however, they can be assisted by these means to achieve their function. Medical devices include supplies for health in the following categories: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, supplies for dental use, surgical and healing materials, hygienic products and other medical products considered for these uses and recognized as medical devices by COFEPRIS per request of the interested party”. Initially, any product that falls under this definition should be considered a medical device. If there is uncertainty concerning a product’s regulatory cat- egory, a request of confirmation of criteria directed to COFEPRIS is encouraged. It is also important to remember the list of products that, due to their nature, characteristics and uses are not considered medi- cal devices, are considered medical devices but do not require an MA or are considered low-risk medi- cal devices subject to a simplified approval process. Products included on this list are not excluded from existing medical device regulations concerning tech- novigilance. There are other categories that are recognised in prac- tice (eg, combination products) but not formally regu- lated through mandatory instruments. 3.2 Marketing Authorisation for Biologic Medicinal Products In general, there is only one type of MA for pharma- ceuticals for human health and for medical devices, which is granted by COFEPRIS. The same require- ments of quality, safety and efficacy apply, regardless of whether the product is allopathic, homeopathic, herbal or a vitamin pharmaceutical. However, there is a significant difference between the extent and scope of safety and efficacy data that would be required for an innovator product compared with a subsequent product, and a specific require- ment for releasing biologic products after importation. Biotech drugs are also subject to a pre-submission regulatory meeting with COFEPRIS’ New Molecules Committee. Please also note that a new class of approvals was introduced during the COVID-19 pandemic (albeit
3. Marketing Authorisations 3.1 Product Classification
The GHL provides a general definition for pharmaceu- ticals, and any product that falls under such definition should be considered a pharmaceutical. According to the GHL, a medicine is any substance or mixture of substances of natural or synthetic origin that has any therapeutic, preventative or rehabilitative properties, is presented in any pharmaceutical form and is identified as such for its pharmacological activity and physical, chemical and biological characteristics. On the other hand, the new definition of medical device contained in Section 3.41 of Standard NOM- 241-SSA1-2025 (NOM-241) is broader: “Medical device, instrument, apparatus, utensil, machine, software, implantable product or material, diagnostic agent, material, substance or similar product, to be used, alone or in combination, directly or indirectly in human beings; with any of the following purposes of use: • diagnosis, prevention, surveillance or monitoring, and/or aid in the treatment of diseases; • diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or aid in the heal- ing of an injury; • substitution, modification or support of the anato- my or of a physiological process; • life support; • control of conception; • disinfection of medical devices; • disinfectant substances; • provision of information through an in vitro exami- nation of samples taken from the human body, for diagnostic purposes; • devices incorporating tissues of animal and/or human origin; and/or • devices used in in vitro fertilisation and assisted reproductive technologies. as well as those whose main purpose of use is not through pharmacological, immunological or meta-
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