All information submitted to the Mexican medical device regulating authority should be provided in the particular form set forth in the appropriate submissions guidance. The authority provides an exhaustive list of requirements the applicants must fulfill.

Physical Presentation Requirements

 

All paper materials regarding submissions should be provided in files with the appropriate identification in accordance with the corresponding matter. The color of the pastes used should correspond with the type of the procedure. The information indicated should include the company name of an applicant, the input name and the file number. Any perforations should not impact the visibility of the information contained in the document, including any stamps or seals. There is no limit on the number of files, but the maximum number of the pages one file should not exceed 500 (five hundred). All pages should be fastened with metallic elements. Sheet protectors are not required for the general document, while they are needed for drawings and blueprint submissions.

According to the recommendations, an applicant must avoid submitting pages with scratches, underlines, hidden or highlighted texts, as well as placing tab dividers, guard sheets, blank sheets or flag pointers to portray a medical device. At the same time, it is recommended to print text and other elements on both sides of sheets to reduce the overall number of pages to be submitted. In this case, however, one side of the sheet should be intentionally left blank.

All sheets should be provided in A4 size, while the legal document could be provided either in A4 size or official size. However, it is admissible to submit documents in sizes other than A4 only in cases when such documents were initially issued in such size. In this case, such documents should be folded at the bottom end.  

Before foliating the documents, an applicant must ensure that the documents are placed in the correct order, complete and there are no unnecessary duplicates. Each sheet should be foliated in the upper right corner in color and size allowing to distinguish it easily from other text on the page for the submissions.

Some of the elements should not be foliated due to their nature while they still should be listed. This rule covers such elements as:

  • Labels, samples of packaging, brochures, newsletters, and other printed materials,
  • Specific elements that could not be integrated into the text and provided in writing,
  • Elements to be returned after the evaluation, such as books, bills, certificates or powers of attorney.

Some documents, like ones to be returned at the time of receipt, as well as original documents provided for comparison, are not required to be listed.

Blueprints Submissions Requirements

 

Drawing, schemes, and blueprints should be protected with the plastic protectors folded according to the size of each element, and the identification box shall remain clearly visible.

According to the recommendations, blueprints should be executed in A1 size with a 1:50 scale, while the minimum acceptable size is A2 with the scale 1:100 respectively, except in certain cases. This is when drawings to portray a medical device served on letter-size sheets are acceptable when performed in the readable scale. In a case when it is necessary to provide a plan for the purpose of authorization, such a plan should be provided in the format 90 x 60.

 

Digital Media Submissions Requirements

 

In certain cases, an applicant shall or may provide information of some kind using digital media. The authority sets forth the following requirements regarding such cases:

  • All digital media carriers should be accompanied with the sheet containing the description of the information the carrier contains. Such an information sheet should be provided in a way ensuring that it would not be lost when transferring and contain the seal of an applicant.
  • Each data carrier should have an identification label or appropriate marks served with indelible ink, and also a description sheet.
  • CDs should be handled using envelopes instead of boxes and duly protected to avoid any deformation.

 

Communications with the Authority

 

The guidance document issued by the authority also describes the rules governing the way and manner all communications to the authority should be filed depending on their type, namely:

  1. Requirements for filing requests. The request should be submitted on a white sheet and contain the following information:
    1. Entry number (if applicable),
    2. Name of the procedure,
    3. Social Reason,
    4. Main information regarding the object related to the reason for filing the request, such as process, product or establishment,
    5. List of folios attached,
    6. A total number of the files dispatched,
    7. Name and signature of the authorized person or legal representative,
    8. Properly filled application form,
    9. Confirmation of fees payment (original and two copies),
    10. Table of contents,
    11. Data and information related to the process requirements.
  2. Requirements for general communications and responses. The communications of this type should contain the following information:
    1. Entry number (if applicable),
    2. Initial application number (if there were no previous communications regarding the same matter),
    3. “NEW” label,
    4. Social Reason,
    5. Main information regarding the object related to the reason for filing the request, such as process, product or establishment,
    6. Information about the applicant and reason is a format: “XXX, ask about YYY”,
    7. A number of folios provided in writing,
    8. A number of folios contained in the file, in writing,
    9. A total number of the files provided, in writing,
    10. Name and signature of the authorized person or legal representative,
    11. Brief description of the reasons,
    12. Table of contents.
  3. Requirements for filing notices. All notices should be foliated and stapled in a folder except ones that should be integrated as a request or advertising notices that do not require a folder.

How Can RegDesk Help?

 

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.

Sources:

https://www.gob.mx/cms/uploads/attachment/file/535715/Guia_Ingreso_Tramites_Febrero_2020.pdf


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