Home > Health > View from the Top

Regulation Ensures Quality, Safety: SOMIB

Ximena Ruiz - SOMIB


Sofía Garduño By Sofía Garduño | Journalist & Industry Analyst - Tue, 01/31/2023 - 11:49

share it

Q: What role does the Mexican Society of Biomedical Engineering (SOMIB) play within the scientific community?

A: SOMIB was the first association for biomedical engineers in Mexico and plays an important role in scientific communication. We have a scientific journal that is published quarterly to promote scientific content and an annual congress that celebrated its 45th edition this year. During this congress, researchers present their work through posters and exhibitions.

We work closely with universities that offer a biomedical engineering degree or a similar program. We seek to promote leadership among young people and encourage them to join SOMIB’s Board of Directors. All committees work hand in hand because they complement each other.

Q: How informed is the industry about sanitary regulation in medical device innovation?

A: Unfortunately, there is a great lack of knowledge regarding regulations. Most biomedical engineering programs do not address regulations. In 2023, we will hold training sessions and workshops at universities to increase awareness on the topic. Students need this education from the start of their university studies because ethics and regulations will be vital in their professional practice as biomedical engineers. Students often think of regulations as an extra burden because they consider their work to be more technical but regulation should be considered a natural area for the profession.

SOMIB participates in the creation of Mexico’s Pharmacopeia, which periodically shares a supplement for medical devices detailing the specific characteristics for them to be sold in Mexico. There is a wide range of medical devices and the pharmacopeia cannot contain a specific monograph for each device. The pharmacopeia has chapters that apply generally to all  medical devices. One way to correct the lack of knowledge regarding the regulation of medical devices is that work tables are set up to review the material and simplify the information for our members. We also represent them and help them voice their concerns.

Q: After the pandemic, what areas of opportunity did you identify in terms of regulation to support innovation efforts in medical devices?

A: The pandemic put a focus on biomedical engineering by increasing demand for medical devices, such as ventilators, face masks and oxygen concentrators. In Mexico, people tried to import devices but many of those got stuck in customs because they lacked import permits. This situation made the need for regulation more visible. Regulation does not limit the industry; it ensures that the products that reach patients are high-quality, effective and safe.

Q: How much presence do women have in the biomedical engineering field?

A: The biomedical engineering field has a good gender balance. By having a more humanistic element, the field is attracting more women, although men are more common in managerial positions, so more opportunities should be opened for women. In the regulatory area, it is more common for women to be in directorships. There are, however, few biomedical engineers working in regulation, which has mainly attracted chemists. We need more female and male  biomedical engineers in regulation to better represent our field.

Q: How is SOMIB working with the public sector to improve regulations?

A: We have not had the opportunity to work with the sanitary authorities but it is among our goals. Unfortunately, the authorities are taking a long time to resolve several manufacturing issues. COFEPRIS does not have enough resources. While the organization is modifying its services to offer assistance through digital platforms, this service has limitations and only addresses a few procedures that are not the most urgent ones for the industry. There are many medical devices and they are continuously changing and evolving, but regulators have been slower to adapt. SOMIB can provide its knowledge to regulators thanks to its alliances.

Q: What are the main challenges foreign companies face in Mexico regarding regulation?

A: The main challenge transnational companies that import their products into Mexico face is that sanitary registries are not issued fast enough for these products to benefit the population. Transnationals that manufacture part of their final product in Mexico, often in Baja California or Chihuahua, will now be impacted by the modification to NOM 241, which enters into force in 2023. These companies will have to observe good manufacturing practices for medical devices.

Q: What will be SOMIB’s priorities for 2023?

A: We are working hard to educate students about regulations and are focused on our scientific journal. The 2023 edition of our congress will take place in Villahermosa, Tabasco, in November and will receive over 1,600 students who will learn from researchers, teachers and opinion leaders.We are working in a blog that will contain important topics regarding medical devices and the development of the biomedical engineer profession  We are also working with CANIFARMA to host a post market surveillance congress.


SOMIB aims to promote biomedical engineering to improve the administration, research, manufacturing and application of medical technology to elevate the quality of health services to the benefit of the patient. 

You May Like

Most popular