Identification and traceability: 7.5.3.1 Identification Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 151 of 248 The manufacturer shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification. The manufacturer shall establish documented procedures to ensure that medical devices and in vitro diagnostic medical devices returned to the manufacturer are identified and distinguished from conforming product. 7.5.3.2 Traceability 7.5.3.2.1 General The manufacturer shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required. Where traceability is a requirement, the manufacturer shall control and record the unique identification of the product. Note: Configuration management is a means by which identification and traceability can be maintained. 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices In defining the records required for traceability, the manufacturer shall include records of all components, materials and work environment conditions, if these could cause the medical device not to satisfy its specified requirements. The manufacturer shall require that its agents or distributors maintain records of the distribution of active implantable medical devices and implantable medical devices to allow traceability and that such records are available for inspection. Records of the name and address of the shipping package consignee shall be maintained.