María Luisa Gutiérrez
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A Reliable Partner for an Uncertain Regulatory Environment

By Miriam Bello | Tue, 10/06/2020 - 16:51

Q: What is Medisis main differentiator as a regulatory consultant for the medical devices sector?

A: Medisi is a facilitator with a global vision and a dynamic soft-landing process. We have taken on the task to understand COFEPRIS so that we can offer our clients a comprehensive service to ensure regulatory approvals in the most efficient way possible. We have international understanding of many regulatory agencies aside from COFEPRIS and this has enabled us to adapt our services and also to develop better solutions for our clients. Regardless of the agency, devices will need to comply with all safety and quality requirements; there is no other way to do it.

We are a very committed company. We understand that these products can be a game changer for patients and the industry in general. Most of our work is based on Class 2 and Class 3 products, which tend to bring positive disruptive changes to healthcare.

Q: How do the changes within COFEPRIS this past year and in 2020 affect your clients?

A: Compared to its global counterparts, such as the FDA, COFEPRIS is a considerably younger agency. While Mexico did have a regulatory framework before it, there was no commission in charge of regulation and it all depended on the Ministry of Health. Within this context, it is important to consider that COFEPRIS is still learning and growing and I do see its yearly changes as an expected evolution. At least in the medical devices sector, I have noticed that the commission is becoming more professional and specialized over time. Still, today there is no specific norm related to medical devices that uses the appropriate language for medical devices, since our current NOM-241 is still in many aspects an adaptation of NOM-059. This becomes evident when looking at the remaining checklist of requirements such as the Certificate of Analysis for a Finished Product, which makes complete sense for Pharmaceutical manufacturers but that really escribes a "Certificate of Conformity” in the medical device area. The medical devices sector is very broad as it contemplates everything from a needle to implantable devices. COFEPRIS has understood that we cannot have the same procedures as pharma.

Aside from this, COFEPRISsituation changes constantly due to shifts in commissioners. Depending on the profile of the commissioner, COFEPRIS will push forward different initiatives, moving from an economics perspective to a legal one. However, its operational essence has remained almost the same.

With the López Obrador administration, the healthcare industry was even doubting that COFEPRIS would still stand. Because of that, it makes sense that the commission has now been attached to the Ministry of Health. I see this as a positive because Deputy Minister of Health Hugo López-Gatell is the one in charge of the area. He has a scientific background and point of view that could greatly benefit the commission and his expertise in the medical field and in research and technology could translate to a considerable improvement within COFEPRIS. We can see López-Gatells expertise in the way he has handled the pandemic; his leadership when dealing with COVID-19 reflects his epidemiological vision. I am looking forward to this vision strengthening the training and visualization of the regulatory process for medical devices.

This administration has already demonstrated that it is responsive as legal approvals will now take an overall time of four months, which is very positive for the market. Quality in the response is still developing but we see this as part of the evolution process. The industry has learned how to work with the commission, which in the past has led us to heavily turn to third parties for improved timelines and answers. That being said, their verdict has always been a mirror of COFEPRIS understanding and point of view of medical devices which at times has proven to be out of touch with reality of manufacturers and can increase costs. At the moment, since the entry of the latest administration third parties’ submissions have received less and less special treatments, diminishing drastically their past advantages.

Q: What opportunities could Mexico take to boost its medical devices sector?

A: Metalsa and FEMSA ventilator development is an example of how this sector is already moving forward. It is very important for Mexico to move beyond manufacturing and into developing its own technology to generate growth and economic spillover. We know that there are companies generating their own devices. However, it is hard for them to export this technology and compete with it in a world-class category. Those who can are normally participating with Class 1 devices, not 2 or 3, which are the most sophisticated. The regulatory process has a lot to do with this because we really do not have the guidelines to develop a Class 3 medical device. Even if a company has the initiative and investment to do so, the lack of regulations can stop business development. Mexico has all the potential to create new innovative solutions; however, we continue to rely heavily on foreign ideas, which prevents our own development.


Medisi is the first Mexican consultancy specialized in medical devices. With a facilitator mindset, a global vision and a dynamic soft-landing process regarding medical devices regulation, the company is consolidating in the US and Latin America

Miriam Bello Miriam Bello Journalist and Industry Analyst