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  • Writer's pictureBerenice Sanchez

The 5 updates to be considered as of 2022 for NOM-241-SSA1-2021

Good Manufacturing Practices for medical devices.

Within Mexico's national legislation for the commercialization of medical devices in the country, one of the greatest challenges to overcome in innovation is the process for obtaining the Certificate of Good Manufacturing Practices granted by COFEPRIS, prior to the submission of the dossier (Dossier) of the health input.

That is why today, we tell you in a brief way the 5 most abrupt changes in the Mexican regulations at the end of 2021.

1. New name. As a first point, it is worth highlighting that the NOM update generated a name change from:

"Good manufacturing practices for establishments dedicated to the manufacture of medical devices." to "NOM-241-SSA1-2021 Good manufacturing practices for medical devices" omitting the word "establishment" the change would seem insignificant, however, it increases the enforcement aspect of the regulation.

2. New structure and content

Concerning the new information published, the importance of inclusion of detailed information on the definition and scope of the Quality Management System, Risk Management, Design and Development, Qualification and Validation Systems is highlighted. Installation criteria, manufacturing equipment were unified or homologated, finally, points of organization of the establishment, handling of non-conforming product, validation, among others, were eliminated.

The general changes among the Mexican Official Standards are shown below.

3. Definition of medical devices

Previously, in NOM-241-SSA1-2012, a medical device was defined as:

"The substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its appropriate use or application), employed alone or in combination in the diagnosis, monitoring or prevention of diseases in humans or auxiliary in the treatment of the same and of disability, as well as those employed in the replacement, correction, restoration or modification of human anatomy or physiological processes"

Medical devices include products in the following 6 categories: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, dental supplies, surgical and healing materials, and hygienic products.

Currently, in the NOM-241-SSA1-2021, the definition has been changed and now the medical device is,

The instrument, apparatus, utensil, machine, software, implantable product or material, diagnostic agent, material, substance or similar product, to be used, alone or in combination, directly or indirectly in human beings; with any of the following purposes of use:

  • Diagnosis, prevention, surveillance or monitoring, and/or ancillary to the treatment of disease;

  • Diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or aid in the healing of an injury;

  • Substitution, modification, or support of anatomy or a physiological process;

  • Life support;

  • Conception control;

  • Disinfection of medical devices;

  • Disinfecting substances;

  • Provision of information by in vitro examination of samples taken from the human body, for diagnostic purposes;

  • Devices that incorporate tissues of animal and/or human origin, and/or

  • Devices used in in vitro fertilization and assisted reproductive technologies;

And whose primary purpose of the use is not through pharmacological, immunological, or metabolic mechanisms, however, they may be assisted by these means to achieve their function. Medical devices include health supplies of the following categories: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, dental supplies, surgical and healing materials, and hygienic products.

4. Risk-based Quality Management System and ISO 13485 equivalence

As some international critical points to increase the safety of medical devices and mitigate potential damages, the definition of the SGM with Risk Management Approach was included and expanded.

From now on, it is stipulated as fundamental and necessary for the manufacture of medical devices to have and implement a Quality Management System with a risk-based approach, taking into account the purpose of use, its intended use of the medical device, as well as its design, development and/or technology transfer.

"The Quality Management System (QMS) represents the set of measures taken in a planned and systematized manner, in order to ensure that medical devices are of the required quality for their intended use." It should include Good Manufacturing Practices, Documentation, Storage and Distribution, and Good Laboratory Practices.

The QMS must consider measures for the continuous improvement of the processes, in addition to containing minimum elements, such as a Quality Policy, the Quality Manual, an audit system, management of complaints and returns, management of non-conforming products, as well as management of deviations, implementing the corresponding CAPA, withdrawal of the product from the market, change control, Master Validation Plan, product monitoring and measurement, technology transfer, risk management, and documentation control.

It is also established that establishments with certification under the current ISO13485 standard issued by organizations authorized by national or internationally recognized accreditation bodies will be recognized in the conformity assessment as equivalent to the Quality Management System required by this current standard.

5. Design and Development

As mentioned above, the process of development and design of medical devices is now considered, that is why a section on the 9 phases suggested in the Design and Development is included:

  1. Design and Development Planning

  2. Design and development inputs

  3. Design and development outputs

  4. Design and development review

  5. Design and Development Verification

  6. Design and development validation

  7. Design and development transfer

  8. Design and development change control

  9. Design and development dossier

If you are interested in learning more about any specific aspect of the updated standard or for advice in the areas of quality and sanitary regulation, please contact us.

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