Agustin Azcatl Romero
Patent Director
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Expert Contributor

What Is Next for Medical Devices?

By Agustin Azcatl Romero | Mon, 08/22/2022 - 13:00

As we have noticed in the last two years, besides the vaccines and drugs necessary to overcome health problems, other health supplies were also relevant, particularly the equipment needed to monitor patient’s evolution, such as oximeters, or in the worst cases, equipment that could replace the function of any organ, such as artificial respirators. Face masks and sanitizers also proved essential.

However, due to the high demand, not all the equipment used complied with the three basic acceptance criteria for health supplies supplies: namely, they are safe, effective, and high quality.

These pieces of equipment and supplies are considered medical devices, which are defined according to NOM-241-SSA-2021 as:

-instruments, apparatus, utensils, software, implantable products, or materials, diagnostic agents, materials, similar substances, or products, to be used alone or in direct or indirect combination in human beings with some the following purposes:

  • Diagnosis, prevention, surveillance, or monitoring of disease treatment;
  • Diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage in the healing of an injury;
  • Replacement, modification or support of the anatomy or of a physiological process;
  • Life support;
  • Birth control;
  • Medical devices disinfection;
  • Disinfectant substances;
  • Provision of information by an in vitro test of samples extracted from the human body for diagnostic purposes;
  • Devices incorporating tissues of animal and/or human origin;
  • Devices used in in vitro fertilization and assisted reproduction technologies.

Medical devices include health supplies in the following categories: medical equipment, prosthesis, orthosis, functional aids, diagnostic agents, supplies for dental use, surgical and healing materials, and hygienic products.

Given the relevance of these devices, the health authority has updated the existing regulation in order to maintain security, efficiency and quality during their manufacturingThe existing regulation is NOM-241-SSA1-2012, published on Oct.11, 2012; the new updated version was published on Dec.20, 2021, which is NOM-241-SSA1-2021, under the heading. Good Manufacturing Practices for Medical Devices, and which comes into force in June 2023. It seems like a long time for a new norm standard to come into force, but I don’t believe it is unusual considering the number of adaptations needed.

On the other hand, another matter that was being discussed during this health emergency was the chance to manufacture medical devices without breaching patent rights. In this emergency, a particular example were artificial respirators. The National Council for Science and Technology (CONACYT) promoted the development and manufacturing of these respirators by the Mexican industry. CONACYT and the developer company had said industrial property rights and that they had no problems if breaches by manufacturing and using them since they were competing with the artificial respirators that they had the patents and that they had the health record in our country.

Besides compliance with good manufacturing practices, it is necessary to have a health record for medical devices, according to article 376 of the General Health Law. The health record shall be in force for five years, which may be extended for equal terms. It must be noted that currently, as a requirement, the filling of the drug health record application has to comply with article 167-bis of the health supply regulation, including in the application the documentation exhibiting the patent ownership of the active substance or ingredient or that has the corresponding license registered with the Mexican Institute of Industrial Property (IMPI) or, if so, state under oath that it complies with the applicable provisions in patent matter in regard to the active substance or ingredient that is the object of the application. It is clear that in this case, it is explicitly requested for drugs; however, medical devices also have industrial property rights and must be considered in the filling of the medical device health record.

As can be seen, It must be proved that in the good manufacturing practices of medical devices and the existence of the industrial property rights thereof, two sections will give us certainty of safety, efficiency, and quality during the manufacturing, distribution, and use of medical devices and that do not breach industrial property rights, thus avoiding breaches and the human resources and monetary investment involved whenever long and expensive lawsuits arise.

The challenge is for companies to invest in the systems and processes implementation that comply with the new regulation related to good manufacturing practices that will soon be in force and that the industrial property rights also be enforced for medical devices.

Photo by:   Agustin Azcatl Romero