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Efficient Regulatory, Ethics Frameworks for Better Health

By Miriam Bello | Mon, 04/19/2021 - 10:21

Q: How does the medical devices sector participate in the Value-Based Healthcare model?

A: This model its at early development stages. However, AMID and its member companies have been encouraging and finding ways to promote this approach where appropriate. For Mexico, this model is especially valuable because, for a long time, companies and governments have worked on enhancing quality healthcare access, which means more patients having access to state-of the-art technology. This is tied to governmental budget and having a willing industry actively looking to innovate in business and payment models can be the first step toward a transformation in the healthcare sector. Value Based-Healthcare and the Payment by Results models are alternatives to large initial investment usually coming from the government to provide patients with a wider chance for a positive outcome.

Q: How else is AMID encouraging medical devices access?

A: Mexico has a very strong standing regarding medical devices production. We are the eighth-largest global exporter of medical devices, the largest exporter in Latin America and the first exporter to the US. However, when it comes to consumption, the country ranks 48th. No company in the sector can have a direct impact on changing this as it is the result of the government’s health investment. However, aside from encouraging models like the ones mentioned above, AMID can work on improving regulation, as part of our consumption lag is also related to poor registration and approval measures for medical devices. Moreover, AMID tries to promote a transparent and critic business environment that promotes good practices. Misuse of the limited resources destined for medical devices is likely to have a significant impact on accessing innovation.

Q: What are AMID’s priorities to be discussed with new COFEPRIS Commissioner Alejandro Svarch?

A: We have had a successful first approach with the new commissioner. He shared a very positive vision in line with the sector’s goals. Commissioner Svarch mentioned that one of his priorities is the digitalization of the commission to simplify processes, speeding approvals and getting rid of the current lags and waiting times. He shared his will for an open and constant dialog with the industry, which is very encouraging.

Q: AMID has been working on updating its ethics code. What is the purpose of this action?

A: At AMID, we are very concerned about transparency, good practices and clear norms to guide the medical industry. We are promoting an ethics code that goes beyond the 39 companies we represent, to be a standard base for the entire medical devices sector. Coupled with this update, we are constantly hosting seminars and training seasons on the subject for technology integrators.

Q: What potential does AMID see for the local medical devices industry to escalate from Level 1 to Level 2 or 3 developments?

A: AMID does not make a distinction between local and multinational companies. We try to unify the industry and see them all as local competitors. Even now, with the UNOPS tender, we try to see all companies as equals. However, if we were to divide them, I do see a strong capacity among local manufacturers to escalate their production. There is a large market to be exploited that could be covered by the infrastructure and qualified workforce Mexico offers.

Q: How would you like your efforts to be portrayed by the end of your term as president of AMID?

A: I am hoping to see a change in regulation. This is and has been a priority for the association for years now and I hope we can bring a positive change. After hearing the plans of the commissioner, I am hopeful this will occur, allowing us to move toward an efficient and safe regulatory framework for all the products we introduce. Access is my second aspiration and this is also in line with AMID’s yearly efforts. We will continue focusing on improving the health of all Mexicans and this can only be done through the right medical equipment.


The Mexican Association of Innovative Medical Devices Industries (AMID) gathers global leaders in innovation of medical devices and diagnostic systems to work toward the advancement of health services in Mexico.

Miriam Bello Miriam Bello Journalist and Industry Analyst