Mexico is one of the largest importers and a remarkable manufacturer of medical devices in the world and specifically gripping in Latin America. Mexico, offering an attractive market for foreign companies, is ministered by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), the Regulatory Body of the Mexican Government. In April 2022, COFEPRIS announced new rules for medical device submission.

Until 2021, every application was printed, gathered, and submitted in physical copies in the submission window of COFEPRIS, including GMP certificate applications, modifications, renewals, warehouse licenses, etc.; all had to be submitted 100 % on paper.

Nevertheless, COFEPRIS finally decided to continue working in a digital platform, allowing several procedures to be concluded in minutes rather than months. The first digital submission platforms were opened for renewals and so-called “self-managing” processes, such as warehouse notice applications, in 2021. COFEPRIS retains its digitalization processes through DIGIPRIS – Platform for procedures and Services of COFEPRIS. In early 2022, new modifications were included in the digital COFEPRIS submission system. Here are the key highlights of the new rules:

Registrations: Mexico is a favorable market for medical devices, which are regulated by COFEPRIS.

• The medical device registration certificate will be valid for five (05) years for initial approval and first renewal
• The renewal submission should be under the same route as the original submission
• Medical device registrations should be submitted online until COFEPRIS issues a homoclave at the COFEPRIS submission website

Good Manufacturing Practices (GMP) Certification: Mexico has its own GMP requirements and they are related to:

• The General Law of Health
• Regulation for Health Supplies
• Regulations from the General Law of Health regarding controls for Health-related activities, establishments, products, and services
• NOM-241-SSAI-2012 in GMP (dedicated to producing medical devices)

In Mexico, a GMP certificate is applicable to the manufacture of medicines, medical devices, or other health supplies manufactured and marketed in the country. To obtain a GMP certificate from COFEPRIS, an application must be submitted with essential documents and an inspection fee. The GMP certification requirements, forms, and export authorization inspection can be done via a digital platform.

Renewals: As the medical devices approval certificate issued by COFEPRIS is valid for five (05) years, It must be renewed to continue marketing devices in Mexican territory. After COFEPRIS grants renewal, the registration validity will be indefinite. Further, the new rules also detail the following:

• Renewal applications should be submitted 270 days prior to the expiration of registration instead of the current 150-day timeline
• All renewals (first and subsequent) should be submitted via an electronic platform
• Each renewal (1^st and 2^nd) shall have a new Unique Identification code called homoclave. The earlier system for Unique identification code was based on Device class or registration route

According to Article 190, the requirements for registration renewal for national manufacturing have been redacted, and only the following listed documents shall be submitted:  

• Proof of payment of rights
• Copy of the sanitary registry in which extension and its modifications are requested
• Post-market surveillance report

In addition to the above, the following documents must be submitted for registration and renewal of the foreign manufactured products:

• Document certifying a legal representative domiciled in the United Mexican States
• GMP certificate of the product, issued by the secretariat or by the equal authority of the country of origin

Post-approval Changes: Most countries and regions have specific requirements for what constitutes a modification, whether minor or major. Mexico is no exception. The new rules define and categorize the changes or modifications into three (03) kinds:

• Administrative changes like addition or change of a distributor, change in the name of the distributor or manufacturing company, legal address of distributor, etc.
• Technical changes like upgradation to new models, formulas, raw materials, device classification, manufacturing site, changes to shelf life, etc.
• Changes related to the transfer of rights, i.e., the change in the sanitary registration holder

All the applications for post-approval changes shall be reviewed within twenty-two (22) business days.

Warehouse License:  It is essential to have a warehouse with a controlled environment for the storage of medical devices to ensure their efficacy, safety, and quality until it is delivered to the final users. The warehouses utilized for the storage of medical devices shall hold a valid “Warehouse License” granted by COFEPRIS.

The applications for warehouse licenses were previously submitted in the form of hard copies. The current rules published by COFEPRIS require that all applications be submitted online only.

On analyzing the aspects that impact medical device registration, the above changes seem to ease the language barrier, and it definitely seems like a boon for companies that are based outside Mexico and willing to register their medical devices in the Mexican market.

To gain further insights for an impact assessment on your device registrations or Regulatory services in Mexico and other LATAM countries, consult Freyr today!