Specific Considerations for Regulating Maternal, Newborn, and Child Health Medical Devices — Market Authorization
Medical devices are a key part of health services for maternal, newborn, and child health (MNCH), and the quality, safety, and reliability of those devices need to be assured.
A national regulatory authority (NRA) assesses information/evidence submitted by the manufacturers of medical devices to verify their safety and performance. The regulation of medical devices for maternal, newborn, and child health (MNCH) has been considered a priority to ensure they are safe and effective for their intended use to the targeted group.
To complement the set of AMDF guidelines for the regulation of medical devices, this MNCH guidance document, developed by the AMDF with support from MTaPS, includes specific considerations for this vulnerable subpopulation, such as unique host characteristics as those pertaining to size, growth, and development; body physique; development milestones; pathophysiology; behavioral factors; psychosocial factors; surgical factors for implantable devices; and guidance for clinical considerations to be considered by manufacturers. The general principles of medical device regulation are also discussed, including risk-based classification of medical devices and applicable risk classification rules, essential principles of safety and performance, and the quality management systems for these medical devices. An assessment of the technical documentation reviews the assessment criteria to be followed and the specific information that assessors can use in reviewing the peculiarities of MNCH medical devices. The use of a reliance model of information sharing and the information to be assessed are also highlighted. The use of this document together with other published guidelines will support regulators in making decisions during the review of technical files for MNCH medical devices.
