Retention of records

Although ISO 9001 and ISO 22716 does not stipulate how long records must be retained for, ISO 13485 is more specific – ‘the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements’

As per the Therapeutic Goods (Medical Devices) Regulations 2002, the manufacturer must keep all manufacturing records for at least 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. Distribution records relating to Class AIMD, Class III or implantable Class IIb medical devices must be retained for inspection by the TGA for 10 years. 5 years is required for all other devices.

Similarly, the EU directives require the retention of manufacturing records for 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. However, for implantable devices, records must be kept for at least 15 years from the last date of manufacture.

About CMS:

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.