In recent years, companies submitting applications in Mexico have had to adjust to a different way of dealing with the health authority. Much of the back-and-forth that once involved physical documentation now takes place within a centralized online system managed by COFEPRIS. That system is known as DIGIPRIS, and it has become the primary channel for handling product registrations and several other regulatory procedures.
In this article, we explain how DIGIPRIS works, what types of products and procedures it covers, and how businesses can use the platform efficiently for regulatory submissions in Mexico.
What Is DIGIPRIS System?
DIGIPRIS is the online system used by Mexico’s health authority, COFEPRIS, to receive and manage regulatory applications. It serves as the official digital channel for submitting product registrations and other sanitary procedures. Companies use the portal to upload documents, track progress, and complete required filings electronically instead of using paper-based submissions.
DIGIPRIS allows users to submit online applications such as
- Product registration
- Import and export permits
- Sanitary approvals
- Advertising notifications
- Establishment notifications / Facility Registrations
- Clinical Trial Authorizations
Features of DIGIPRIS
DIGIPRIS provides a centralized online platform for managing and tracking regulatory submissions with COFEPRIS.
- Online submission of regulatory applications
- Secure user account for companies and representatives
- Digital upload of required documents
- Real-time application status tracking
- Electronic communication with COFEPRIS reviewers
- Support for various procedures including registrations and permits
- Reduction of in-person visits and paper documentation
Products Covered Under DIGIPRIS
DIGIPRIS is used for several types of regulated products in Mexico, particularly those that require authorization or registration before being placed on the market. The platform supports applications across multiple sectors, depending on the regulatory classification of the product.
DIGIPRIS supports submissions for:
- Medical devices, including higher-risk categories that require formal registration
- Medicines, including biological products
- Food items and dietary supplements
- Cosmetics
- Healthcare materials and related items
- Herbal and traditional products
Using DIGIPRIS for Submissions Management
To use DIGIPRIS, users must first create an account and register their business. Once registered, users can create and submit applications for regulatory approval online. DIGIPRIS provides users with detailed instructions on how to complete each application, and allows them to upload all required documentation electronically. DIGIPRIS procedures can be divided into two main categories: self-managing processes and electronic submissions.
Self-Managing Processes
Self-managing processes are fully digitalized and can be completed without the need for COFEPRIS intervention. These processes include:
- Warehouse notice updates
- Modifications to company representation details
- Suspension or cancellation of product registrations
The relevant form is selected inside the DIGIPRIS system, and the requested information is submitted electronically.
Electronic Submissions
Not all procedures in DIGIPRIS are completed independently. Many applications — such as product registrations, clinical trial authorizations, import and export permits, and sanitary certificates — are submitted through the same portal but require evaluation by COFEPRIS. After submission, the file enters the review stage, where authorities may request clarification or additional documentation before reaching a final decision.
To make online submissions and notices in COFEPRIS, the site is DIGIPRIS:
In order to access Digipris, the e-firma or FIEL is used (two names for the same identifier), this is comprised of three coded archives: Certiicate, Private Key, Passcode. FIEL also known as e-firma is the identifier given by Mexico tax department, meaning only those registered as taxpayers in Mexico may enter. And FIEL exists for both companies and individuals.
Inside Digipris, there are four different types of submissions as described in the COFEPRIS site:
- Premaket authorization renewals for pharmaceuticals and medical devices.
NOTE: All authorizations have to be renewed as follows:
For the first time, 5 years after receiving the pre market authorization.
For the following renewals, every 10 years.
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- The renewals can be submitted online or at the window, the response may be retrieved online or at the window.
Handbooks for these submission can be found in the provided website.
- Self-managed submissions, which do not require a written response from COFEPRIS or a signature from any authority.
- These DIGIPRIS submissions include: product notifications, company registration (Notice of operation) for foods, food supplement, cosmetics, marketing notices for cosmetics, notice of operation for pharmaceutical warehouses that do not need a license of operation (only psychotropics/ controlled substances and biologicals such as vaccines or hemoderivates require license).
- These submissions are not accepted at any window, so it is mandatory to make them online.
- For commodities, the submissions are made using the FIEL for the company and once the online format is complete, they must be signed with the FIEL of the legal representative registered at COFEPRIS.
- For pharma which requires both a legal representative and a sanitary officer, the signatures at the end must be by both the legal representative and the sanitary officer.
- Clinical trials, which require prior authorization from COFEPRIS are also submitted via DIGIPRIS.
- First time premarket authorization for medication using CTD documentation can be submitted through DIGIPRIS.
- The site will display the CTD requirements which must be uploaded and completed.
In order to make any of these submissions it is necessary to know the code for the specific submission, as well as the required information that will be uploaded when submitting.
- There are a few procedures not included in this list:
- Marketing materials permit for food supplements, are still submitted at the window.
- Classification letters, general consultations, are still submitted at the window.
- Medical device first time premarket authorizations, at the COFEPRIS window.
- Free Sale certificates, submitted at the COFEPRIS window.
- License of operation for pharmaceutical manufacturing or processing, or for warehouses that carry biologicals and controlled substances, are also submitted at the COFEPRIS window.
For all of these there is also a submission code and information required.
In order to get the code and requirements, there is a link to the formats with a pdf instructive per format here.
“Autorizaciones, Certificados y Visitas” format covers the premarket authorization. It is necessary to review the PDF where the code for the specific procedure is indicated along with the format spaces to fill out and the list of attachments. This format is not the CTD document. For submissions made using CTD, the CTD guidelines apply.
“Aviso de Funcionamiento, de Responsable Sanitario y de Modificación o Baja” format for the self managed procedures. Again, the PDF instructions are necessary to get the specific code and specific areas that will be filled out online.
How Artixio Supports Your DIGIPRIS Submissions
If you are a business that needs help using the DIGIPRIS system, Artixio can help. Our team of experts can help you to:
- Create an account and register your business with DIGIPRIS
- Complete and submit applications for regulatory approval
- Track the status of your applications and respond to requests from COFEPRIS reviewers
- Ensure that your applications are compliant with all applicable Mexican regulatory requirements
Contact Artixio today to learn more about how we can help you to use the DIGIPRIS system to streamline the regulatory process for your products in Mexico. Contact us at info@artixio.com