Pharmaceutical Good Manufacturing Practice Regulations Article 108

In defining the records required for traceability of active implantable medical devices and implantable medical devices, manufacturers shall include records of all components, materials and work environment conditions, if these could cause the medical device not to satisfy its specified requirements.Manufacturers shall require that their agents or distributors maintain records of the distribution of active implantable medical devices and implantable medical devices to facilitate the need for traceability and inspection.Manufacturers shall maintain the name and address of the shipping package consignee of active implantable medical devices and implantable medical devices.