Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document was released by the Sanitary Authorization Comission (CAS) –a division of COFEPRIS that approves Sanitary Registrations, Import Permits and other official authorizations.
In this article we highlight the main features you have to consider before submitting a request (here referred as “the dossier”) to COFEPRIS. We focus only on submissions related with medical devices.
Characteristics of the dossier
Considering that paper is used in the majority of the submissions. COFEPRIS has settled in this guide that all the dossiers presented in paper must have the following features:
- Organized in separated files containing a maximum of 500 sheets each one.
- Fastened with aluminum screw posts of adequate size to avoid loose sheets.
- Use sheet protectors to save original documents that should not be perforated nor foliated (e.g. legal documents).
- Identify each individual file with a printed label containing:
- Type of submission.
- Company name.
- Generic or distinctive name for the medical device.
- File number.
- Total files in the dossier.
- The cover color in all files, depending on the type of request, must be:
|Type of request
|New sanitary registration
|Extension of sanitary registration
Moreover, you should avoid:
- Perforate relevant information and seals.
- Use sheet protectors for ordinary documents.
- Underline, cross out, hide or highlight text.
- Use sheet separators, adhesive strips (Post-it) and blank sheets.
Finally, it is recomended:
- Print sheets by both sides.
- Write “No Text” in the back of one side printed sheets.
The specifications for numbering all sheets contained in the dossier are as follow:
- Number all pages at the upper-right corner in the front side.
- Use a numbering machine with color and size that allows easy identification.
- Start by numbering the last page of the dossier.
- Include single copies of all legal documents and number those duplicates.
- Cancel wrong numbers with diagonal lines.
To be avoided, when numbering sheets:
- Use handwriting for numbering sheets.
- Use correction fluid or labels to fix numbering mistakes.
Do not number the following documents
- Printed materials such as: product labels, containers, brochures, among others.
- Documents expected to be returned by COFEPRIS after reviewing your request including medical prescriptions, invoices, certificates, power of attorney, etc.
- Any other document when it is disordered, illegible or incomplete.
- You must use letter size sheets for all the dossiers.
- Legal documents can be presented in A4 or Legal size.
- All documents larger that a letter size sheet must be folded by the lower edge to fit.
Digital media storage devices (DMSD)
The following rules must be followed when attaching a DMSD (i.e. CDs, DVDs, USB flash drives):
- Mark DMSD with an adhesive label and/or permanent marker.
- Add a properly numbered sheet including the description of the DMSD included and its content.
- Place the digital media and their description sheet inside a sealed sheet protector.
- When you include a CD or DVD it must be inside an envelope, not to use plastic boxes.
The content included in the dossier must be arranged as follows:
- Identify the proper COFEPRIS code submitting evidence that all requirements are met to choose the COFEPRIS code in the dossier.
- Submit all the information in the original language and its translation into Spanish when applicable. Expert translation is required for legal documents.
- Sort the information included in the dossier according to the checklist for each kind of request, prevention or as requested by COFEPRIS.
- Send all necessary information in a single dossier as no further information is accepted.
For new requests, free writings and response to preventions:
- The dossier must include a cover with the following data:
- Number of submission (will be filled by COFEPRIS).
- Number of initial request (only for preventions).
- COFEPRIS code.
- Name and type of request.
- Company name.
- Keywords of the request reason (new request, response, and consultation.)
- Number of sheets included in each file.
- Total files.
- Name and signature of the sanitary responsible or legal responsible.
- Request form (filled and complete).
- Deposit receipt, original document and two copies inside a sheet protector.
- Table of contents.
- This section must mention at least the documents that by requirement are integrated into the application (the order of the checklists should be followed when applicable).
- Consider at most three levels of detail and identify the numbering in which each section is located.
- Information corresponding to the requirements.
We strongly recommend to follow this guide to avoid any complication during the COFEPRIS submission. To learn more about these rules please contact Veraque.
Also, check our guides for further details and hints!