{"id":1828,"date":"2024-08-29T19:33:13","date_gmt":"2024-08-29T19:33:13","guid":{"rendered":"https:\/\/www.ibarrapg.com\/?p=1828"},"modified":"2026-04-06T18:50:21","modified_gmt":"2026-04-06T18:50:21","slug":"proposed-official-mexican-standard-proy-nom-241-ssa1-2024","status":"publish","type":"post","link":"https:\/\/www.ibarrapg.com\/en\/proposed-official-mexican-standard-proy-nom-241-ssa1-2024\/","title":{"rendered":"Proposed Official Mexican Standard PROY-NOM-241-SSA1-2024"},"content":{"rendered":"

The purpose of this note is to inform you about the new proposed Official Mexican Standard \u201cPROYNOM-241-SSA1-2024<\/strong>\u201d (the \u201cStandard<\/span>\u201d), which was published in the Official Gazette of the Federation (for its Spanish acronym \u201cDOF<\/span>\u201d) on July 26th, 2024. This proposal is generally focused on the medical device manufacturing industry<\/strong>. The Standard will be submitted to a specialized committee, which will provide their technical opinion and justification within 60 (sixty) days after the Standard comes into force. Additionally, once the Standard is published in the Official Gazette, it will come into effect 180 (one hundred eighty) days thereafter.<\/p>\n

Goal, Scope of Application and Quality Management System<\/h4>\n

The objective of the Standard is to ensure that these products (medical devices) consistently meet the necessary requirements for quality, safety and performance<\/strong> to be used by consumers or patients. This Standard is mandatory throughout national territory and applies to all establishments engaged in the manufacturing, storage, conditioning and distribution of medical devices<\/strong>.<\/p>\n

The proposal defines a set of essential terms for its correct interpretation and application, such as Good Documentation<\/strong> Practices (\u201cGDP<\/span>\u201d), Good Storage and Distribution<\/strong> Practices (\u201cGSDP<\/span>\u201d) and Risk Management<\/strong>. It also includes normative references that must be consulted for proper implementation, such as NOM-005-STPS-1998<\/a><\/strong>, which establishes safety and hygiene conditions<\/strong> in workplaces for the handling, transportation and storage<\/strong> of hazardous chemicals and NOM-073-SSA1-2015<\/a><\/strong>, which defines and establishes the requirements for conducting stability studies<\/strong>, including their design and execution<\/strong> for drugs and medications intended for use<\/strong> as well as for research<\/strong>.<\/p>\n

The quality management system is a central component<\/strong> of this Standard, requiring establishments to design, implement, document, and maintain<\/strong> quality management systems that incorporate GMP, GDP, GSDP and risk management principles. This system must be reviewed periodically<\/strong> to ensure its effectiveness and continuous improvement.<\/p>\n

Subcontracting, Quality Control and Studies<\/h4>\n

In the case of the subcontracting of services, the Standard requires that any activity impacting the quality of the medical device<\/strong> must be formally contracted and controlled to avoid inaccuracies. This includes technology transfer and process validation<\/strong> at the subcontractor’s facilities.<\/p>\n

Additionally, to ensure a consistent supply of highquality materials<\/strong>, strict criteria<\/strong> must be established for the selection and evaluation of suppliers<\/strong>. This includes conducting initial and periodic audits<\/strong> to assess the supplier’s ability<\/strong> to meet quality requirements. Continuous monitoring<\/strong> of the supplier’s performance is essential, using quality indicators, delivery times, and compliance with technical specifications. Contracts with suppliers should include representations specifying the expected quality standards<\/strong> and the consequences of failing to meet these standards. Furthermore, constant and open communication<\/strong> with suppliers must be encouraged to proactively anticipate and resolve quality issues<\/strong>.<\/p>\n

The Standard establishes detailed procedures for the release of medical devices<\/strong>, both imported and domestic, including inspections, analytical certifications<\/strong>, and cold chain monitoring. It requires the retention of samples<\/strong> and documentation of special transportation and storage conditions<\/strong>.<\/p>\n

For devices with an expiration date, stability studies<\/strong> must be conducted under specific conditions, documenting accelerated and real-time stability tests<\/strong>. It also regulates remanufacturing and refurbishment<\/strong>, requiring specific areas and procedures to ensure traceability and quality, with approved alternate facilities.<\/p>\n

The Standard requires comprehensive and accessible documentation<\/strong> for audits, with detailed records of production, inspection, and testing<\/strong>. It establishes procedures for the creation, review and archiving of documents<\/strong>, and the implementation of backup systems. Finally, it regulates the handling of waste and counterfeit devices<\/strong>, mandating their proper disposal and destruction<\/strong>.<\/p>\n

This Standard will supersede the Official Mexican Standard<\/strong> NOM-241-SSA1-2021<\/a> for Good Manufacturing Practices of Medical Devices.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

The purpose of this note is to inform you about the new proposed Official Mexican Standard \u201cPROYNOM-241-SSA1-2024\u201d (the \u201cStandard\u201d), which was published in the Official Gazette of the Federation (for its Spanish acronym \u201cDOF\u201d) on July 26th, 2024. This proposal is generally focused on the medical device manufacturing industry. The Standard will be submitted to […]<\/p>\n","protected":false},"author":3,"featured_media":2004,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1828","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-otros"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/posts\/1828","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/comments?post=1828"}],"version-history":[{"count":4,"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/posts\/1828\/revisions"}],"predecessor-version":[{"id":3394,"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/posts\/1828\/revisions\/3394"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/media\/2004"}],"wp:attachment":[{"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/media?parent=1828"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/categories?post=1828"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ibarrapg.com\/en\/wp-json\/wp\/v2\/tags?post=1828"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}