Medical devices, the sector with the brightest future in Mexico and ISO 45001

Medical devices, the sector with the brightest future in Mexico and ISO 45001


Mexico is the eighth largest exporter of medical devices in the world, first in Latin America and the main supplier to the United States. Mexico is also the third largest exporter of tubular suture needles in the world, the fourth largest exporter of instruments and devices for medicine, surgery, dentistry and veterinary medicine, and the fourth largest exporter of medical furniture, syringes, catheters, cannulas and similar instruments.

The need for medical devices increases every day, and currently, for more than a year, demand has increased due to the Covid-19 pandemic.

The medical device industry contributes to the GDP of our country, it can be said that in addition to contributing to our economy, it contributes to improve the quality of health care, promotes research, the creation of new technologies that improve the quality of life of patients and improves the way of working in hospitals by optimizing the resources they have.

The creation and use of these devices allows to complement medical treatments, offering effectiveness when solving their ailments. Not only does it help prevention, but it also makes it possible to update the ways of diagnosing diseases.


The outlook of this sector shows a promising progress, Mexico has medical device manufacturing plants that range from the manufacture of devices to the healing material. It continues with a high level of growth and development thanks to the demand for a better quality of life that is increasing every day, that is why it is necessary to innovate in terms of medical devices.

It is worth mentioning some of the main products exported by Mexico:

Medical, surgical and dental instruments.
Orthopedic devices for fractures
X-ray equipment
Massage devices, aerosol therapy devices
Medical devices manufactured in Mexican companies under ISO 45001.

The production of medical equipment is divided into classifications according to the characteristics presented.

CLASSIFICATION I. Inputs that are used in medical practice and are not introduced into the organism.
CLASSIFICATION II. Inputs used in medical practice. There are variations in the material with which they were made, generally they are introduced into the organism for a period of less than 30 days.
CLASSIFICATION III. New instruments used in medical practice, these are introduced into the organism and remain in it for more than 30 days.

These classifications in turn are divided into different categories according to their use:

Surgical and healing material.
Prostheses, orthoses, functional aids: Those whose purpose is to substitute or complement a function, body tissues or organs.
Diagnostic agents: Test strips, calibrators, verifiers, antigens, antibodies, any device that can be used as a complement in other procedures.
Dental supplies.
Hygienic products: Materials for external use, applied to body cavities and skin surface. Within this category are condoms, disinfectant gels, etcetera.

medical devices


The objective of ISO 45001 is to completely eliminate or reduce any factor that can cause harm to both your organization and your employees. Being the standard in charge of occupational health and safety management systems, it is responsible for taking care of the personnel working in your organization, protecting them from accidents and illnesses that may occur at work.

What this standard tries to do is to lower the death statistics of workers since, according to records of the International Labor Organization, there are more than 2.7 million deaths per year due to accidents at work, 374 million accidents, also counting with 4 days of sick leave on average for each worker who has suffered an accident.


The certification of your organization under an occupational health and safety management system helps you to verify that the systematic processes consider the risks and consequences that can be generated within your organization. The medical devices sector and other existing sectors apply within this system because the benefits that can be obtained are of great help for the positive development of your workers.

Following the guidelines of the 45001 standard assists you in determining all the risks that the worker may have at the time of performing their work, to establish the necessary controls to manage risks, to ensure that all staff are aware of the damage that may exist within the organization and to put controls on the actions to be taken to work safely, try to eliminate and minimize them.

In addition to increasing the participation of workers on the detection of risks, encourage communication within your organization, to increase the good reputation of the company, showing it as a responsible company, which is committed to the welfare of their workers and one of the relevant parts is that it reduces the costs intended to cover accidents at work and reduces the faults at work.

At QAlliance, our team is trained to guide you and provide you with the necessary support for your organization to become certified and continue to meet the goals and objectives you have established. Contact us and we will gladly provide you with the necessary information.

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