WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 7.5-combination: For medicine-device combination products, follow the designated regulatory pathway (by primary mode of action), meet the GMP or QMS, verification and post-market requirements set for the product, and show safety and performance of the whole with quality of the medicinal substance

What does 7.5-combination require?

Combination products are designated by the NRA, normally by primary mode of action, as mainly medicines or mainly devices, with a single product-specific authorization pathway combining both sets of requirements. Manufacturers must meet the requirements set for the product's manufacture, quality assurance, testing, distribution, inspection and post-market surveillance and reporting (based on medicines GMP or device QMS as designated); where a device incorporates a medicinal substance, safety and performance must be shown for the whole together with the substance's identity, safety, quality and efficacy in that combination (such devices are Class D under IMDRF rules).