Technovigilance to Support, Accelerate Medical Device Approval

Regulation is essential to ensure the safety and efficacy of medical devices but requires consistent monitoring to be truly effective. Medical device developers and regulators are thus investing in technovigilance to monitor the performance of available devices, ensuring that they adhere to sanitary regulations. 

“Technovigilance is a system for the identification and evaluation of adverse events produced by medical devices,” explains COFEPRIS. Technovigilance is not only essential for medical device manufacturers and regulators, but also for healthcare professionals, patients and their families. Training and education for both medical personnel, patients and their families on the proper use of medical devices is critical to the effective use of medical devices, says Lorena Garza, CEO, Expertos 360. 

Garza highlights that technovigilance must be the industry’s ally because manufacturers, suppliers and healthcare institutions can greatly benefit from this technology, which gives them the necessary information to do risk analysis and benefit the patient. Technovigilance ensures that medical devices in Mexico are safe, efficient and fulfill their purpose. If a device presents adverse effects, measures have to be taken to eliminate or decrease the probability of recurrence of these events, according to medical imaging firm Guerbet. 

Sanitary registration guarantees that a medical device has been subjected to strict evaluation before its commercialization. Holders of sanitary registries of medical devices must have a technovigilance unit in charge of developing and implementing vigilance and safety measures, reports CANIFARMA. 

Although regulation aims to protect the Mexican population, there is significant uncertainty among medical devices manufacturers. “There are several studies from various associations in Mexico that show that COFEPRIS is lagging behind and has been a bottleneck in accessing innovation,” Mario Muñoz, General Manager North Latam Region, IQVIA, tells MBN. 

These regulatory gaps delay or inhibit innovation in medical devices. “Many times, the creation of medical devices begins without taking regulation into account and innovation is not leveraged,” explained Maria Ximena Ruiz, President, SOMIB’s National Regulatory Committee. 

However, Mexico’s regulatory processes delay the entrance of new innovation by many years, limiting the patient’s ability to benefit from state-of-the-art technology. Montserrat Galindo, Head of Market Access, Masimo, suggests that a regulatory framework that goes at the same speed as medical device innovation is necessary to help ensure patient’s safety. Coordination between all industry players is also essential to streamline medical device approval and adoption.

“There is a lack of coordination between the main medical organizations in Mexico. We need to share our best practices and experience to facilitate the work that regulatory institutions do and benefit the patient with the latest innovations in the health and medical equipment sector,” says Galindo. 

Mexico has an official technovigilance standard but it is still incipient in comparison to those of other regions. However, while traditionally slow, Mexican regulators have greatly transformed medical device laws in recent years because the industry has been adapting faster to international trends and technologies.

The deployment of homologated requirements across the industry will allow foreign medical devices to arrive faster to the patients, says Karla Sánchez, Health and Regulatory Affairs Manager, Association for Sanitization and Certification (ANCE). Medical devices manufacturing is complex and the industry needs a robust regulatory framework to ensure patient safety while adapting to the market’s innovation.

There is a long way to go before regulators can match the speed at which the industry is evolving. The only way they can catch up is through the generation of open and clear communication channels connecting regulators with industry experts, says Sánchez. 

The industry must work hand in hand with regulatory institutions as soon as it begins designing a new medical device to facilitate launch of the product. Mexico needs to work on educating and supporting healthcare institutions to implement the latest innovations in technovigilance, says Yolo Macías, Independent Consultant. Regulation of medical devices should not be limited to hospital equipment because equipment for personal use, such as smartwatches that monitor vital signs, is also necessary to ensure user safety, adds Macías.

Cybersecurity is another crucial matter that must be addressed to protect client information. As the data and technology already exist, the industry must take actions now to ensure patient’s security and privacy, says Macías. As opportunities that come from accessing Big Data grow, the risk of cyberattacks also increases.

Training the general public in the importance of technovigilance is also key to allow the industry receive feedback that can help improve medical devices, says Ximena Ruiz, Secretary, Mexican Society of Biomedical Engineering (SOMIB). The active participation of all stakeholders in the medical sector, academia, industry associations and colleges can ensure that the entire industry participates in the successful implementation of regulatory processes, explains Ruiz.