GMP

Regulatory Update Mexico Releases Draft Standard for Medical Device Manufacturing: SaMD & QMS in Focus (Updated)

Regulatory Update Mexico Releases Draft Standard for Medical Device Manufacturing: SaMD & QMS in Focus (Updated)

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.