Updated good manufacturing practice (GMP) requirements for medical devices on the Mexican market have taken effect as of June 20, 2023.
The latest version of Mexican Official Standard NOM-241-SSA1-2021, Good manufacturing practices for medical devices (hereafter NOM-241), published December 20, 2021, and coming into effect on June 20, 2023, establishes the minimum requirements for medical device manufacturers and supply chain stakeholders related to design, development, manufacturing, storage and distribution activities to comply with quality, safety and functionality requirements.
All establishments dedicated to the manufacture, conditioning, storage, and distribution (supply chain) of medical devices located in Mexico must comply with these GMP guidelines.
Here are the three changes that are having the biggest impact.
1. Scope of application of the standard
It is mandatory in Korea for all facilities dedicated to the manufacture of medical devices and extends the scope of application of the standard.
2. Design and development by manufacturing line
Highlight the development and design process of the medical device and highlight that it is the responsibility of the development area personnel to document the procedures, detailing the requirements to be met for each particular manufacturing line of the medical device.
3. Quality management systems based on risk-based approaches
To ensure that medical devices are of the quality required for their intended use, the new regulations establish the importance of maintaining a quality management system (QMS). The system represents a planned and structured set of measures and is designed, planned, implemented, maintained and ensured by continuous improvement of the process, taking into account good manufacturing standards, documentation, storage and distribution, good laboratory standards and risk management principles.
Please refer to the link below for more information.
DOF - Diario Oficial de la Federación
dof.gob.mx
If you have any questions about medical device certification,
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info@jnmglobal.net