The "Guide for Modifications to Medical Devices" provides detailed criteria and requirements for requesting administrative and technical modifications to medical device sanitary registration conditions in Mexico. The document outlines various types of modifications that can be requested, including changes in ownership, distributors, manufacturers, importers, and product details such as commercial name, catalog number, packaging material, and presentation codes. It also specifies the necessary documentation for different types of modifications, emphasizing the importance of complying with technical and legal requirements according to current legislation.
Furthermore, the guide highlights the significance of ensuring medical device safety, efficacy, and quality by submitting accurate and complete documentation. It distinguishes between administrative modifications, such as changes in company information or corrections in the sanitary registration, and technical modifications, which involve alterations in product specifications, manufacturing processes, or labeling.
Update
The guide describes two main types of modifications to the conditions of medical device sanitary registration:
Administrative Modifications: These include changes in ownership, distributors, manufacturers, importers, and details such as commercial name, catalog number, packaging material, and presentation codes.
Technical Modifications: These involve alterations in product specifications, manufacturing processes, labeling, sources of radiation, changes in maquilador (national or foreign), devices with exclusive presentation for public health or social security institutions, changes in manufacturing site, changes in primary packaging material, changes in expiration date, new product presentations that do not include technological advances altering the primary purpose of use, and changes in formula that do not involve substitution of the active ingredient.
The guide provides detailed information on the specific requirements for each type of modification, whether administrative or technical. It outlines the necessary documentation, forms, and procedures that need to be followed when requesting changes to the conditions of medical device sanitary registration. By following the guidelines provided in the guide, stakeholders can ensure that they meet all the requirements set forth by the regulatory authorities in Mexico, such as COFEPRIS, for each type of modification they wish to make
Additionally, the updated guide describes the documentary requirements to be met for each type of modification. Letter No. COFEPRIS-CFS-125-2024, dated February 20, 2024 (see in Sources), complements the provisions by which a priority lane (Ventanilla de Atención Inmediata) can be applied for modifications to the sanitary registration of medical devices outlined in this update.
Regulatory framework
The regulatory framework outlined in the guide for modifications to medical devices includes various laws, regulations, and official standards that govern the registration and modification processes for medical devices in Mexico. Some key components of the regulatory framework mentioned in the guide are:
Ley General de Salud (General Health Law): This law establishes the legal framework for health regulations in Mexico, including provisions related to medical devices.
Reglamento de la Comisión Federal para la Protección contra Riesgos Sanitarios (Regulation of the Federal Commission for the Protection against Sanitary Risks): This regulation specifies the responsibilities and procedures of COFEPRIS, the regulatory authority overseeing health risks in Mexico.
Norma Oficial Mexicana (Official Mexican Standard) NOM-001-SSA1-2020: This standard establishes the structure of the Mexican Pharmacopeia and the process for its revision, updating, editing, and dissemination.
Other regulations and agreements related to the Secretaría de Salud (Ministry of Health) and COFEPRIS include those concerning good manufacturing practices for medical devices, labeling requirements, and specific procedures for modifying sanitary registrations.
Effects from the RA update
By following the guidelines outlined in this document, stakeholders in the medical device industry can navigate the process of requesting modifications to sanitary registrations effectively and in compliance with regulatory standards in Mexico.
Written By:
Ana Carla Díaz
About ips
Our regulatory affairs team helps medical device manufacturers obtain the necessary sanitary licenses to commercialize their products in Mexico. We have a deep understanding of the local regulatory framework and a proven track record of success. We offer a wide range of services to meet your specific needs. Contact your service leader or email us at info@insumosparasalud.com to learn more.