Introduction
The Mexican Official Standard PROY-NOM-241-SSA1-2024, titled Good Manufacturing Practices for Medical Devices, has been proposed and published in the Official Gazette of the Federation. This standard aims to define the minimum requirements for the design, development, manufacturing, storage, and distribution of medical devices for human use, tailored to their risk levels.
The primary objective of this standard is to ensure that medical devices consistently meet the necessary quality, safety, and performance criteria for use by consumers or patients.
Key Steps for Medical Device Companies
The application of PROY-NOM-241-SSA1-2024 requires medical device companies to adhere to several key steps:
- Establishment of Procedures
- Personnel Training
- Implementation of Procedures
- Monitoring and Control
- Management of Non-Conformities
- Continuous Improvement
- Communication with Regulatory Authorities
Implementing these requirements demands organization-wide commitment, from senior management to frontline staff. Ensuring the quality and safety of medical devices is a shared responsibility across all levels of the organization.
Public Comment Period
The project is open for public comment for 60 calendar days from its publication date. Interested parties are encouraged to submit their feedback in Spanish and with adequate technical support. During this period, the foundational documents and Regulatory Impact Analysis will be available for public consultation.
Link to Source
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |