Third Party Units Can Streamline Regulations, Support Innovation

Q: How does ANCE support and empower entrepreneurs in the health industry?

A: ANCE has over 30 years of experience in compliance assessment and standards generation. From the beginning, we have been expanding our business lines to continue building an association that provides comprehensive services. In healthcare, ANCE began as an authorized third party for the evaluation of medical devices, speeding up their sanitary registration. We generate technical reports and review all the administrative, legal and technical information required by authorities to grant sanitary registries. A year later, we expanded our scope and started working with the pharmaceutical industry.

However, this administration implemented several changes within COFEPRIS, which stopped recognizing our technical reports. Consequently, demand dropped considerably but we continue to maintain our current authorization and provide services as an authorized third party. In 2019, we diversified to offer comprehensive solutions that allow us to help more clients comply with all regulatory requirements. We also work with an electromagnetic compatibility laboratory that offers electrical efficacy and safety testing services for electromedical equipment. Our strategic allies allow us to cover every step of the medical device supply chain, allowing our clients to find the solution to all their needs in one place.

Q: What does ANCE expect from the new administration? 

A: The situation has been uncertain because our technical reports are not being recognized by authorities and there is no official pronouncement as to what will happen to third-party verification units. The units were created to support COFEPRIS during the approval process, allowing it to address requests that were lagging behind. We supported the authorities and want to continue doing so. I cannot understand why COFEPRIS decided to stop recognizing third parties. We would like the authorities to audit us so they can understand that we comply with all their requirements. We hope the new administration will be willing to listen to us and find a way for us to help the industry so Mexicans can access new and improved technologies.

Q: How does the regulatory framework for the healthcare industry in Mexico compare with the rest of Latin America’s?

A: ANCE has various representative offices in Mexico, China and Colombia. The Colombia office was inaugurated last year and serves as a link between Mexico and Colombia. The classification of medical devices in Colombia is aligned with the classification followed by the EU. In Mexico, the classification of medical devices is based on Article 83 of the Health Supplies Regulation. Colombia’s National Institute for the Surveillance of Medicines and Food (INVIMA) has a digital platform that supports the industry in many ways but Mexico only recently launched DIGIPRIS, which is in its initial stages and needs improvement.

Q: What opportunities will the homologation of standards among COFEPRIS, the US Food and Drug Administration (FDA) and Health Canada bring? 

A: Since 2010, Mexico has had equivalency agreements with Health Canada, the FDA and Japan’s Ministry of Health. However, this is a unilateral agreement as Mexico recognizes marketing authorizations from the other three agencies but they do not recognize Mexico's. A more agile and expeditious review process would give the population access to treatments and allow regulation to keep pace with innovation. In Mexico, it takes about two years to grant a sanitary registration and the homologation could help streamline processes.

Q: What does the reform to the General Law of Health in the areas of medical devices and the fight against illegal products represent for the industry?

A: During the past few years, efforts have been made to change the General Law of Health to clarify the definition of medical devices, as they are currently considered health supplies. Recently, the Chamber of Deputies approved this initiative.

Changes to Article 464 of the General Law of Health will allow the imposition of penalties and fines on those who illegally sell or counterfeit medical devices. To raise awareness of this matter, COFEPRIS launched information sessions called EDUCAPRIS for the industry. Similar sessions would be useful for the general public, helping them to stop taking risks associated with using illegal medical devices. 

 Q: What are ANCE’s priorities for 2023?

A: ANCE keeps pace with the regulatory framework. A growing trend in healthcare is Software As a Medical Device (SaMD), which is generating both expectations and doubts. We are waiting for the official publication of the regulatory framework for this type of medical device. We also aim to provide a comprehensive service through our laboratories and qualified personnel. 

We aim to keep pace with regulations, which are dynamic, and we hope to continue supporting the authorities. We will continue to innovate to offer leading solutions to our customers.

ANCE is a leader in the development of standards and regulations to improve market competitiveness.