Launch of the Medical Device Sanitary Registration Viewer: A step towards information analysis and consultation.

Sep 18

On August 20, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) launched the Medical Device Sanitary Registration Viewer. This dynamic, up-to-date platform consolidates information on sanitary registrations granted for medical devices, facilitating real-time verification of the validity and legal status of registrations issued by COFEPRIS. It features a dynamic interface with multi-criteria search capabilities covering various parameters, such as brand name, generic name, category, risk class, and registration holder.

The launch of the Medical Device Sanitary Registration Viewer marks a turning point toward transparency and regulatory modernization. It aligns the Mexican health authority with international standards promoted by bodies such as the International Medical Device Regulators Forum (IMDRF) by making open data available through a query platform designed to match global benchmarks like EUDAMED (the European Union platform) and AccessGUDID (managed by the U.S. FDA).

- Medical Device Sanitary Registration Viewer

UPDATE

On August 20, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) made the Medical Device Sanitary Registration Viewer available to the public and the industry. This digital public inquiry tool enables the search, verification, and analysis of both current and historical sanitary authorizations issued in the country.

COFEPRIS has indicated that the platform will undergo continuous updates, allowing registration records to be maintained and displayed in real-time as registration conditions or regulatory statuses change. Only sanitary registrations that comply with applicable legal provisions will be included on the platform.

What is the Sanitary Registration Viewer?

The Sanitary Registration Viewer is a public digital platform designed to centralize and systematize sanitary authorizations granted for medical devices in the country, enabling real-time access to this information. It features multi-criteria search capabilities, with the following key characteristics:

Advanced and Multi-criteria Search: Allows for filtering and querying registrations using key variables such as:
- Sanitary registration number
- Medical device type (based on risk class)
- Medical device classification (based on medical device category)
- Brand name
- Generic name
- Sanitary registration holder
- Full dataset (download of the complete database of sanitary registrations published in the viewer).
Centralized and Historical Interface: Access to consolidated real-time data, reducing reliance on static PDF lists or historical bulletins.
Data Export: Ability to download lists and reports in structured formats (such as CSV or Excel), facilitating the processing of large volumes of information.
Dynamic Visualization: Incorporates dashboards and visual indicators regarding the distribution of registrations by category, risk class, and manufacturing origin.

Search filters allow users to query sanitary registrations granted by COFEPRIS without needing the registration number. Searches can be performed by brand or generic name, or by medical device class or category, enabling quick and dynamic inquiries.

What information is displayed in the Medical Device Sanitary Registration Viewer?

Through the Medical Device Sanitary Registration Viewer, users can access a detailed record for each registration issued by COFEPRIS. This platform breaks down key data associated with each registration, including:

Sanitary registration number
Name of the sanitary registration holder
Status of the sanitary registration (active or undergoing renewal)
Medical device classification (based on the medical device category)
Medical device type (based on risk class)
Brand name and generic name
Advertising (targeted at healthcare professionals or the general public, or both)
Date of issuance and validity period
Validity date of the renewal
Indication for use and description.

COFEPRIS has established a mechanism allowing registration holders to verify and validate the information displayed in the viewer and submit observations regarding the data to correct errors, thereby facilitating access to up-to-date information. Holders have a two-week window to submit their comments to the email address digipris@cofepris.gob.mx.

EFFECTS FROM RAUPDATE

What is the purpose of the Medical Device Sanitary Registration Viewer?

The Medical Device Sanitary Registration Viewer provides the industry, distributors, users, and public sector institutions with centralized access to structured data regarding the status of registrations issued by the authority. This tool facilitates the analysis and consultation of information for various practical applications, notably:

Facilitating precise correlation between health alerts/field safety notices and the official registration numbers currently valid in the country for the products described in those notices.
Mapping competitors and the technical state-of-the-art of similar products already registered in Mexico to inform market access strategies.
Immediate verification of the validity and current status of the Sanitary Registration.
Consulting prior criteria applied by the authority to confirm the risk classification of similar medical devices.

A Step Toward International Convergence

The implementation of interoperable digital platforms aligns the Mexican authority with international standards promoted by bodies such as the International Medical Device Regulators Forum (IMDRF). The availability of open data not only strengthens post-market surveillance but also fosters an environment of fair competition and legal certainty for technological innovation in healthcare.

The COFEPRIS Sanitary Registration Viewer aims to match global benchmarks such as EUDAMED (European Union) and AccessGUDID (US FDA), allowing for an assessment of the Mexican authority's progress while simultaneously identifying the technological and regulatory gap that still separates us from international convergence.

Written by:

Mauricio Amaro

Senior Regulatory Affairs Analyst at Insumos para la Salud, S.A. de C.V. with extensive experience in the sanitary regulation of medical devices. Specialist in the comprehensive management of registrations before COFEPRIS, dossier evaluation, and coordination of efficacy evaluation projects with accredited national laboratories.

About IPS

At IPS, we specialize in guiding the medical device industry through regulatory compliance. With our extensive experience in the sanitary regulation of medical devices, we are experts in designing and implementing effective strategies tailored to the requirements and guidelines of the Equivalence Agreement pathway and the Abridged Regulatory Pathway. Our team of experts not only understands the regulations, but also translates these guidelines and simplifies regulatory complexity to accelerate the market entry of health technologies in Mexico.