This article was first published on July 3th, 2024
The Ministry of Health in Mexico is proposing changes to a standard (NOM-240-SSA1-2012) regarding medical device safety and reporting. The draft standard strengthens reporting requirements for manufacturers, distributors and adds new responsibilities.
Update
On June 27, 2024, the Ministry of Health, through CONAMER (National Commission for Regulatory Improvement), published a draft to modify the NOM-240-SSA1-2012 Standard.
After that, last July 24, 2024 the draft NOM-240-SSA1-2024, Installation and operation of post-marketing surveillance, was published in the Official Gazette of the Federation (DOF by its acronym in spanish).
The publication of the draft opens a 60-day public consultation period. During this time, interested parties can submit comments and suggestions to refine the standard before its final implementation.
If the draft standard is approved, it will be published in the DOF and enter into force in 180 calendar days. The standard becomes enforceable once it's published as an Official Mexican Standard in the DOF and after the specific timeframe.
Additional terms and definitions are proposed to strengthen safety and quality among the parties involved. It is important to mention the addition of Software as a Medical Device definition.
The new project adds new responsibilities for Sanitary Registration Holders in Mexico, the most notable is to have documentary evidence regarding the risk posed by using the medical device according to the risk management carried out in the design and development stage. Furthermore, to inform the authorities about Sanitary Registration cancelation, revocation, or transfer of rights, international safety alerts that result in a national recall.
In addition, Distributors are incorporated in the responsibilities. They must have a PMS unit and a responsible person to communicate with the National Center of Pharmacovigilance (CNFV). The PMS unit is required to have at least 10 Standard Operation Procedures; the following are added to the current standard: Training and diffusion of PMS activities, Trend reporting based on Risk Management, Reporting and follow-up of field safety corrective actions, and Research for security alerts.
New requirements for 5 year-PMS report are added such as trends report and international information about medical device security.
The notification criteria are simplified and the notification exceptions are more detailed. It should be noted that the notification times from the current standard remain.
Finally, the authority will provide Guides for PMS development activities that will be available on the COFEPRIS website for public consultation.
Regulatory framework
The regulatory framework is based on various articles of the Organic Law of the Federal Public Administration, article 39; the Federal Law of Administrative Procedure, article 4; and the General Health Law with articles 3o, 17 bis, 194, 194 bis, 195, 201, 210, 212, 213, 214, 262, 263, 264, 265, and 376. Additionally, the Law of Quality Infrastructure with articles 3, 10, 30, 34, 35, 37, 38, and 139 d, among others, is considered. Furthermore, regulations such as NOM-241-SSA1-2021, NOM-137-SSA1-2008, and specifying the Pharmacopoeias of the United Mexican States 5.0 and 6th Ed.
Effects from the RA update
The proposed standard represents a substantial enhancement to Mexico's regulatory framework for medical devices. Its nature will facilitate the development of a robust post-market surveillance system, thereby contributing to the improvement of patient safety and device performance.
Written By:
Gabriela Pedraza
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Our PMS team helps medical device manufacturers proactively monitor the performance of their products in Mexico. We offer a suite of services to help you navigate the new regulations, from standard operating procedures to PMS implementation, as well as a wide range of services to meet your specific needs.
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