printable version | January 2022
On December 20, 2021, the Ministry of Health published, in the Official Gazette of the Federation, the new Mexican Official Standard NOM-241-SSA1-2021, Good manufacturing practices for medical devices, which aims to establish the minimum requirements for the processes of design, development, manufacturing, storage and distribution of medical devices for use by the patient or final consumer. According to the General Health Law, medical devices include medical equipment, prostheses, orthoses and functional aids, diagnostic agents, dental supplies, surgical and healing materials, as well as hygienic products.
The aforementioned NOM classifies medical devices according to the risk that their use represents: Class I, Class II and Class III. Likewise, the Quality Management System, through the measures adopted, guarantees the quality of medical devices for their intended use, incorporating the standards of GMP, GMP, GMP, GMP and the principles of Risk Management.
Additionally, the standard establishes criteria for the design and development of medical devices, which must be planned by the person responsible for the development area of the same, as well as the requirements that must be met by the facilities and equipment used at the time of manufacturing, storage and release of finished products on the market, to guarantee the quality of the medical devices.
Based on the above requirements, a system for qualification and validation of compliance with the standard is incorporated, as well as studies on the stability and final destination of waste, also establishing a complaints system for users that makes the communication of faults with the devices effective.
The entry into force of this Standard will render the Mexican Official Standard NOM-241-SSA1-2012, Good manufacturing practices for establishments dedicated to the manufacture of medical devices.
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