Navigate COFEPRIS: Your Mexico FDA Equivalent for Medical Devices

Introduction

Navigating the complex landscape of medical device regulation in Mexico demands a thorough understanding of COFEPRIS, the country’s counterpart to the FDA. This regulatory body is crucial in ensuring the safety and efficacy of health-related products, making it imperative for manufacturers to become well-acquainted with its guidelines. As the market evolves, new reforms and compliance requirements present both opportunities and challenges for MedTech companies.

How can manufacturers effectively navigate these complexities to ensure successful product launches and enhance patient access to innovative technologies?

Understand COFEPRIS and Its Role in Medical Device Regulation

The Federal Commission for the Protection against Sanitary Risks is recognized as the , overseeing the safety and effectiveness of , medications, and pharmaceuticals. Operating under the Ministry of Health, this regulatory agency enforces stringent safety standards that all medical devices must meet before entering the Mexican market. For manufacturers, grasping the is essential, as it delineates the necessary documentation, , and approval processes vital for .

In January 2026, the agency introduced a reform allowing subsequent renewals for periods of up to ten years. This change underscores the importance of a proactive compliance strategy to navigate the complexities of the Mexican market effectively. Additionally, adherence to Article 376 is crucial for manufacturers to ensure compliance with local regulations. Bioaccess® specializes in facilitating this process, leveraging its expertise to help navigate the regulatory and efficiently meet ANMAT registration requirements.

As the regulatory authority states, “The agency must approve your regulatory application before you can sell your healthcare product in Mexico, in accordance with the .” Understanding the not only simplifies market entry but also . This ultimately leads to successful approvals for and improved patient access to innovative technologies.

Identify Medical Devices Regulated by COFEPRIS

into three primary categories based on risk levels:

1. Class I (low risk)
2. Class II (moderate risk)
3. Class III ()

Understanding these classifications is essential for navigating the effectively. Each class comes with .

, require minimal documentation and typically undergo a streamlined approval process, often completed within 30 days. In contrast, , which include syringes and infusion pumps, involve moderate risk and necessitate a more detailed submission, with an approval timeline of approximately 35 days.

, are considered and demand extensive . This leads to a more stringent review process that can take up to 60 days. Grasping the categorization of your equipment is crucial for effectively .

Follow the COFEPRIS Medical Device Registration Process

To successfully register a medical product with the health authority, follow these essential steps:

1. Determine : Identify your device’s risk class, as this will dictate the you must meet.
2. : Compile essential documents, including a technical dossier, , and proof of compliance with applicable standards. Precise translation of all documentation into Spanish is crucial for evaluation by the health authority. Additionally, ensure compliance with ANMAT requirements where applicable.
3. Submit Application: File your application with the health regulatory authority, ensuring that all documents are complete and correctly formatted.
4. : Pay the necessary registration charges, which differ by classification. For instance, Class II categories generally incur fees ranging from $3,000 to $8,000, while Class III categories can exceed $15,000.
5. Await Review: , with a decision usually provided within 30 business days for low-risk items, due to the accelerated 30-day approval process. However, the complete approval process can take up to 30 months depending on the complexity of the item.
6. Receive Registration: Upon approval, you will obtain a , which permits you to market your device in Mexico. It’s important to note that the Mexico FDA equivalent has a rejection rate of approximately 20% for applications, emphasizing the need for thorough preparation and compliance with all requirements. Furthermore, it is advised to initiate the approval process 12-18 months prior to your planned market entry to account for any unforeseen delays. For a comprehensive understanding, consider the as well.

Meet Key Compliance Requirements for COFEPRIS

To comply with COFEPRIS regulations, manufacturers must adhere to several key requirements:

1. : Implement a (QMS) that meets . This is essential for ensuring consistent quality in . ISO 13485 establishes a framework for effective quality management, enhancing compliance with regulatory requirements and fostering continuous improvement in processes.
2. : Ensure that all product labeling complies with NOM-137-SSA1-2008, which mandates that . This is crucial for consumer safety and clarity, as proper labeling assists users in comprehending the product’s intended use and any associated risks.
3. : Conduct a to demonstrate the safety and efficacy of the apparatus, particularly for higher-risk classifications. This evaluation must encompass a thorough examination of available clinical data, ensuring that the product meets the necessary safety standards before it can be marketed.
4. : Create a strategy to track the performance of the product and notify the regulatory authority of any negative incidents. This ongoing monitoring is vital for maintaining product safety and efficacy after the device has been introduced to the market.
5. Documentation Maintenance: Ensure all documentation is current and easily accessible for inspections or audits. Proper and facilitating a smooth regulatory process.

In 2026, revisions to ISO 13485 compliance requirements will further align with regulatory standards, reflecting the changing landscape of healthcare product regulation in Mexico. Following these guidelines not only guarantees conformity but also boosts the trustworthiness and appeal of healthcare products in a competitive landscape.

Utilize Mexico’s Abbreviated Regulatory Pathway for Faster Approvals

has unveiled a streamlined approval process, enabling producers to register medical products based on prior endorsements from recognized regulatory bodies, similar to the . This initiative is crucial for enhancing in Mexico. To effectively navigate this pathway, follow these :

1. Confirm Eligibility: Ensure your device mirrors one previously approved by a recognized authority, maintaining the same formulation, intended use, and manufacturing process.
2. Prepare Simplified Documentation: Submit a concise application that references the existing approval, along with any additional required documentation, which may include translations and administrative formalities.
3. Submit Application: File your application through the , typically resulting in a decision within a target review period of just .
4. Monitor Progress: Keep track of your application status and be prepared to provide any additional information requested by COFEPRIS.

This new pathway significantly reduces the , with estimates indicating a 70-80% decrease in the paperwork required for international healthcare product manufacturers. By leveraging existing approvals, manufacturers can expedite their entry into the Mexican market, ultimately improving access to essential medical devices through the for both patients and providers. Industry leaders emphasize that if the 30-day timeline is consistently upheld, it will represent a transformative shift in efficiency, facilitating quicker access to vital medical technologies. Furthermore, as part of bioaccess’s Global Trial Accelerators™, we offer critical and market access strategies that empower medtech startups to successfully .

Conclusion

Understanding COFEPRIS and its role as Mexico’s counterpart to the FDA is essential for any manufacturer looking to introduce medical devices into this growing market. The agency’s stringent oversight guarantees that all health-related products adhere to rigorous safety and efficacy standards, fostering trust and credibility among consumers and healthcare providers alike.

This article highlights crucial aspects of navigating COFEPRIS, including:

• The classification of medical devices into risk categories
• The comprehensive registration process
• The compliance requirements that manufacturers must follow

By outlining the necessary steps for successful registration and underscoring the significance of quality management and post-market monitoring, it becomes evident that thorough preparation is vital for securing approval and maintaining product integrity.

In conclusion, engaging with COFEPRIS not only opens avenues to the Mexican market but also elevates the overall quality of healthcare products available to patients. Manufacturers are urged to take advantage of the newly introduced abbreviated regulatory pathway to expedite approvals, ultimately enhancing access to innovative medical technologies. By prioritizing compliance and grasping the regulatory landscape, stakeholders can contribute to a healthier future for all, ensuring that safe and effective medical devices reach those who need them.

Frequently Asked Questions

What is COFEPRIS and what is its role in medical device regulation?

COFEPRIS, the Federal Commission for the Protection against Sanitary Risks, is Mexico’s equivalent of the FDA. It oversees the safety and effectiveness of health-related products, medications, and pharmaceuticals, enforcing stringent safety standards for medical devices before they enter the Mexican market.

What should manufacturers understand about COFEPRIS?

Manufacturers need to grasp the regulatory framework established by COFEPRIS, which includes necessary documentation, compliance requirements, and approval processes essential for successful product launches in Mexico.

What recent reform did COFEPRIS introduce in January 2026?

COFEPRIS introduced a reform allowing subsequent renewals of medical device approvals for periods of up to ten years, highlighting the importance of a proactive compliance strategy.

How does Article 376 relate to manufacturers?

Adherence to Article 376 is crucial for manufacturers to ensure compliance with local regulations set forth by COFEPRIS.

What is the significance of understanding COFEPRIS for market entry?

Understanding COFEPRIS simplifies market entry and enhances the credibility of producers, leading to successful approvals for health-related products and improved patient access to innovative technologies.

How does COFEPRIS classify medical devices?

COFEPRIS classifies medical devices into three categories based on risk levels: Class I (low risk), Class II (moderate risk), and Class III (high risk).

What are the approval requirements for Class I medical devices?

Class I devices, such as bandages and non-invasive diagnostic tools, require minimal documentation and typically undergo a streamlined approval process, often completed within 30 days.

What is the approval process for Class II medical devices?

Class II devices, including syringes and infusion pumps, involve moderate risk and necessitate a more detailed submission, with an approval timeline of approximately 35 days.

What is required for Class III medical devices?

Class III devices, such as cardiac pacemakers and artificial heart valves, are considered high risk and require extensive clinical data, leading to a more stringent review process that can take up to 60 days.

Why is it important to understand the classification of medical devices?

Grasping the categorization of medical devices is crucial for effectively navigating the registration and compliance landscape with COFEPRIS.

List of Sources

1. Understand COFEPRIS and Its Role in Medical Device Regulation
   • bioaccessla.com (https://bioaccessla.com/blog/master-cofepris-guidelines-for-medical-devices-compliance)
   • mddionline.com (https://mddionline.com/medical-device-regulations/mexico-s-shortened-regulatory-timetable-attracts-medical-device-manufacturers)
   • mexicobusiness.news (https://mexicobusiness.news/health/news/mexicos-cofepris-rolls-out-anti-counterfeit-plan)
   • medenvoyglobal.com (https://medenvoyglobal.com/blog/what-is-cofepris-for-medical-devices)
   • pureglobal.com (https://pureglobal.com/markets/mexico/cofepris-medical-device-regulations)
2. Identify Medical Devices Regulated by COFEPRIS
   • emergobyul.com (https://emergobyul.com/services/classification-medical-devices-mexico)
   • regdesk.co (https://regdesk.co/regulations-library/mexico)
   • emergobyul.com (https://emergobyul.com/services/cofepris-medical-device-and-ivd-registration-and-approval-mexico)
   • pureglobal.com (https://pureglobal.com/markets/mexico/cofepris-medical-device-and-ivd-classification)
3. Follow the COFEPRIS Medical Device Registration Process
   • medenvoyglobal.com (https://medenvoyglobal.com/blog/do-i-need-cofepris-approval-to-sell-in-mexico)
   • artixio.com (https://artixio.com/post/case-study-ensuring-cofepris-regulatory-compliance-for-health-supplements-in-mexico)
   • chameleon-pharma.com (https://chameleon-pharma.com/cofepris-now-offers-drugs-and-medical-devices-registration-in-30-45-days-what-to-expect-from-the-new-digipris-platform)
   • artixio.com (https://artixio.com/post/mexico-cofepris-regulations-for-medical-device-registration)
   • linkedin.com (https://linkedin.com/posts/bennyarazy_medicaldevices-ivd-regulatoryupdates-activity-7429673864135118849-XqtI)
4. Meet Key Compliance Requirements for COFEPRIS
   • ivemsa.com (https://ivemsa.com/medical-device-manufacturing-mexico-overview)
   • veraqueconsulting.com (https://veraqueconsulting.com/mx/clinical-evaluation-studies-for-medical-device-approval-in-mexico)
   • Get Quote Authorized Representative Mexico Devices Steps To Compliance | bioaccess® (https://bioaccessla.com/blog/get-quote-authorized-representative-mexico-devices-steps-to-compliance)
   • artixio.com (https://artixio.com/blog/cofepris-compliance)
   • emergobyul.com (https://emergobyul.com/resources/mexico-overview-medical-device-industry-and-healthcare-statistics)
5. Utilize Mexico’s Abbreviated Regulatory Pathway for Faster Approvals
   • pureglobal.com (https://pureglobal.com/news/mexico-cofepris-2025-abbreviated-pathway-for-medical-devices)
   • mddionline.com (https://mddionline.com/medical-device-regulations/mexico-s-shortened-regulatory-timetable-attracts-medical-device-manufacturers)
   • globalregulatorypartners.com (https://globalregulatorypartners.com/cofepris-introduces-abbreviated-regulatory-pathway-reliance-to-accelerate-health-product-approvals-in-mexico)
   • pureglobal.com (https://pureglobal.com/blog-posts/mexicos-abbreviated-regulatory-pathway-is-a-game-changer-for-medical-device-market-access)

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This regulatory body is crucial in ensuring the safety and efficacy of health-related products, making it imperative for manufacturers to become well-acquainted with its guidelines. As the market evolves, new reforms and compliance requirements present both opportunities and challenges for MedTech companies. \n\nHow can manufacturers effectively navigate these complexities to ensure successful product launches and enhance patient access to innovative technologies?\n\n## Understand COFEPRIS and Its Role in Medical Device Regulation\n\nThe Federal Commission for the Protection against Sanitary Risks is recognized as the , overseeing the safety and effectiveness of , medications, and pharmaceuticals. Operating under the Ministry of Health, this regulatory agency enforces stringent safety standards that all medical devices must meet before entering the Mexican market. For manufacturers, grasping the is essential, as it delineates the necessary documentation, , and approval processes vital for .\n\nIn January 2026, the agency introduced a reform allowing subsequent renewals for periods of up to ten years. This change underscores the importance of a proactive compliance strategy to navigate the complexities of the Mexican market effectively. Additionally, adherence to Article 376 is crucial for manufacturers to ensure compliance with local regulations. Bioaccess® specializes in facilitating this process, leveraging its expertise to help navigate the regulatory and efficiently meet ANMAT registration requirements.\n\nAs the regulatory authority states, \”The agency must approve your regulatory application before you can sell your healthcare product in Mexico, in accordance with the .\” Understanding the not only simplifies market entry but also . This ultimately leads to successful approvals for and improved patient access to innovative technologies.\n\n## Identify Medical Devices Regulated by COFEPRIS\n\ninto three primary categories based on risk levels:\n\n1. Class I (low risk)\n2. Class II (moderate risk)\n3. Class III ()\n\nUnderstanding these classifications is essential for navigating the effectively. Each class comes with .\n\n, require minimal documentation and typically undergo a streamlined approval process, often completed within 30 days. In contrast, , which include syringes and infusion pumps, involve moderate risk and necessitate a more detailed submission, with an approval timeline of approximately 35 days.\n\n, are considered and demand extensive . This leads to a more stringent review process that can take up to 60 days. Grasping the categorization of your equipment is crucial for effectively .\n\n\n\n## Follow the COFEPRIS Medical Device Registration Process\n\nTo successfully register a medical product with the health authority, follow these essential steps:\n\n1. Determine : Identify your device’s risk class, as this will dictate the you must meet.\n2. : Compile essential documents, including a technical dossier, , and proof of compliance with applicable standards. Precise translation of all documentation into Spanish is crucial for evaluation by the health authority. Additionally, ensure compliance with ANMAT requirements where applicable.\n3. Submit Application: File your application with the health regulatory authority, ensuring that all documents are complete and correctly formatted.\n4. : Pay the necessary registration charges, which differ by classification. For instance, Class II categories generally incur fees ranging from $3,000 to $8,000, while Class III categories can exceed $15,000.\n5. Await Review: , with a decision usually provided within 30 business days for low-risk items, due to the accelerated 30-day approval process. However, the complete approval process can take up to 30 months depending on the complexity of the item.\n6. Receive Registration: Upon approval, you will obtain a , which permits you to market your device in Mexico. It’s important to note that the Mexico FDA equivalent has a rejection rate of approximately 20% for applications, emphasizing the need for thorough preparation and compliance with all requirements. Furthermore, it is advised to initiate the approval process 12-18 months prior to your planned market entry to account for any unforeseen delays. For a comprehensive understanding, consider the as well.\n\n\n\n## Meet Key Compliance Requirements for COFEPRIS\n\nTo comply with COFEPRIS regulations, manufacturers must adhere to several key requirements:\n\n1. : Implement a (QMS) that meets . This is essential for ensuring consistent quality in . ISO 13485 establishes a framework for effective quality management, enhancing compliance with regulatory requirements and fostering continuous improvement in processes.\n2. : Ensure that all product labeling complies with NOM-137-SSA1-2008, which mandates that . This is crucial for consumer safety and clarity, as proper labeling assists users in comprehending the product’s intended use and any associated risks.\n3. : Conduct a to demonstrate the safety and efficacy of the apparatus, particularly for higher-risk classifications. This evaluation must encompass a thorough examination of available clinical data, ensuring that the product meets the necessary safety standards before it can be marketed.\n4. : Create a strategy to track the performance of the product and notify the regulatory authority of any negative incidents. This ongoing monitoring is vital for maintaining product safety and efficacy after the device has been introduced to the market.\n5. Documentation Maintenance: Ensure all documentation is current and easily accessible for inspections or audits. Proper and facilitating a smooth regulatory process.\n\nIn 2026, revisions to ISO 13485 compliance requirements will further align with regulatory standards, reflecting the changing landscape of healthcare product regulation in Mexico. Following these guidelines not only guarantees conformity but also boosts the trustworthiness and appeal of healthcare products in a competitive landscape.\n\n\n\n## Utilize Mexico’s Abbreviated Regulatory Pathway for Faster Approvals\n\nhas unveiled a streamlined approval process, enabling producers to register medical products based on prior endorsements from recognized regulatory bodies, similar to the . This initiative is crucial for enhancing in Mexico. To effectively navigate this pathway, follow these :\n\n1. Confirm Eligibility: Ensure your device mirrors one previously approved by a recognized authority, maintaining the same formulation, intended use, and manufacturing process.\n2. Prepare Simplified Documentation: Submit a concise application that references the existing approval, along with any additional required documentation, which may include translations and administrative formalities.\n3. Submit Application: File your application through the , typically resulting in a decision within a target review period of just .\n4. Monitor Progress: Keep track of your application status and be prepared to provide any additional information requested by COFEPRIS.\n\nThis new pathway significantly reduces the , with estimates indicating a 70-80% decrease in the paperwork required for international healthcare product manufacturers. By leveraging existing approvals, manufacturers can expedite their entry into the Mexican market, ultimately improving access to essential medical devices through the for both patients and providers. Industry leaders emphasize that if the 30-day timeline is consistently upheld, it will represent a transformative shift in efficiency, facilitating quicker access to vital medical technologies. Furthermore, as part of bioaccess’s Global Trial Accelerators™, we offer critical and market access strategies that empower medtech startups to successfully .\n\n\n\n## Conclusion\nUnderstanding COFEPRIS and its role as Mexico’s counterpart to the FDA is essential for any manufacturer looking to introduce medical devices into this growing market. The agency’s stringent oversight guarantees that all health-related products adhere to rigorous safety and efficacy standards, fostering trust and credibility among consumers and healthcare providers alike. \n\nThis article highlights crucial aspects of navigating COFEPRIS, including: \n- The classification of medical devices into risk categories \n- The comprehensive registration process \n- The compliance requirements that manufacturers must follow \n\nBy outlining the necessary steps for successful registration and underscoring the significance of quality management and post-market monitoring, it becomes evident that thorough preparation is vital for securing approval and maintaining product integrity. \n\nIn conclusion, engaging with COFEPRIS not only opens avenues to the Mexican market but also elevates the overall quality of healthcare products available to patients. Manufacturers are urged to take advantage of the newly introduced abbreviated regulatory pathway to expedite approvals, ultimately enhancing access to innovative medical technologies. 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