The DIGIPRIS system (Sistema Digital de Procesos y Servicios Regulatorios, or Digital System of Regulatory Processes and Services) is a digital platform developed by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS, or Federal Commission for the Protection against Sanitary Risks) of Mexico.
DIGIPRIS was launched in 2020 as part of COFEPRIS's efforts to modernize its operations and improve the efficiency and transparency of its regulatory processes. The platform has been well-received by the regulated community, with over 20,000 users registered and more than 10,000 procedures processed since its launch. It allows users to submit and process various sanitary procedures and services online, including:
Import and export permits
Establishment notifications / Facility Registrations
Clinical Trial Authorizations
DIGIPRIS offers a variety of features and benefits to users, including:
Convenience: DIGIPRIS allows users to submit and track applications for regulatory approval online, from anywhere in the world.
Efficiency: DIGIPRIS automates many of the manual tasks involved in the regulatory process, which can significantly reduce the time it takes to get products approved.
Transparency: DIGIPRIS provides users with real-time updates on the status of their applications, and allows them to interact with COFEPRIS reviewers electronically.
Reduced costs: DIGIPRIS eliminates the need for users to travel to COFEPRIS offices or submit paper applications, which can save them a significant amount of time and money.
DIGIPRIS streamlines and automates the regulatory process for medical devices, food products, and other health-related products. Products that can be registered through DIGIPRIS include:
Medical devices: All Class III and Class IV medical devices, and Class I and Class II medical devices (optional)
Pharmaceuticals: Drugs, biological products, and medical devices for human use
Food: Processed foods, beverages, and dietary supplements
Cosmetics: Personal care products, including skin care, hair care, and makeup products
Medical supplies: Medical equipment, instruments, and materials
Other healthcare products: Homeopathic products, herbal products, and traditional Mexican medicines
DIGIPRIS is currently available for a limited number of regulatory procedures, but COFEPRIS is working to expand its scope in the coming years. As of today, DIGIPRIS can be used to submit applications for the following procedures:
Medical devices: Registration, modification, renewal, and cancellation of registrations for medical devices of all classes.
Food products: Registration, modification, renewal, and cancellation of registrations for food products of all types.
Other health-related products: Registration, modification, renewal, and cancellation of registrations for other health-related products, such as cosmetics, food supplements, and traditional medicines.
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 are fully digitalized and can be completed without the need for COFEPRIS intervention. These processes include:
Requesting a warehouse notice amendment
Changing the legal representative of a company
Suspending or canceling a product registration
To initiate a self-managing process, users must log in to DIGIPRIS and select the "Self-managing processes" section. From there, they can select the specific process they want to initiate and follow the instructions.
Electronic submissions are also digitalized for Product and registrations, Clinical trial authorizations, Import and export permits and Sanitary certificates, but they require COFEPRIS review and approval. To initiate an electronic submission, users must log in to DIGIPRIS and select the "Electronic submissions" section. From there, they can select the specific submission they want to initiate and follow the instructions.
Once an application has been submitted, it will be reviewed by a COFEPRIS reviewer. The reviewer may request additional information or documentation from the user. Once the review is complete, the reviewer will approve or deny the application.
Users can track the status of their applications in real time using the DIGIPRIS portal. DIGIPRIS also provides users with the ability to interact with COFEPRIS reviewers electronically. For example, users can submit questions or request clarification from reviewers.
Overall, the DIGIPRIS system is a valuable tool for businesses that need to obtain regulatory approval for their products in Mexico. It offers a number of benefits, including convenience, efficiency, transparency, and reduced costs.
The DIGIPRIS system is a significant development in the Mexican regulatory landscape for medical devices and other regulated products. It offers a number of benefits to users, including convenience, speed, transparency, and cost savings.
If you are a business or individual that needs to interact with COFEPRIS, I encourage you to learn more about the DIGIPRIS system and how it can help you to streamline your regulatory processes.
How Artixio Can Help
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.