The Ministry of Health in Mexico is proposing changes to a standard (NOM-240-SSA1-2012) regarding medical device safety and reporting. The draft standard strengthens reporting requirements for manufacturers, distributors and adds new responsibilities. Public feedback is welcome to evaluate the impact of the proposed changes.
Mexico published a draft standard (PROY-NOM-241-SSA1-2024) on June 26th for public review. This update aims to make Good Manufacturing Practices for Medical Devices more specific by including details on areas like quality management and software as medical device.
At COFEPRIS's priority lane (VRI) , the transfer of rights for medical devices, pharmaceuticals, pesticides, and plant nutrients will be resolved within 24 business hours, streamlining the process for those involved.
The guide provides detailed criteria and requirements for requesting administrative and technical modifications to medical device sanitary registration conditions in Mexico.
