IMDRF Guidance on the Control of Products and Services Obtained from Suppliers
| Issuing Body | International Medical Device Regulators Forum (IMDRF), Quality Management Systems Working Group |
| Opening Date | 06/05/2026 |
| Closing Date | 06/07/2026 |
| Status | Closed |
| Consultation Website | https://www.imdrf.org/consultations/guidance-control-products-and-services-obtained-suppliers |
The IMDRF Quality Management Systems Working Group is seeking your feedback, which will be considered prior to finalisation of the attached guidance document for publication.
This document is a revision of the document GHTF SG3 (Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers – December 2008) to reflect the current state of the art and experience gained from use of the initial version. It provides regulatory guidance for manufacturers on the control of products and services obtained from suppliers, throughout the life cycle of medical devices.
Note: This guidance applies to all medical devices, including IVD medical devices and combination products (if regulated as medical devices).
This guidance is applicable to manufacturers of medical devices, irrespective of their size, and can be used by other interested parties providing a service or product such as importers and distributors.
MTAA is happy to submit a consolidated response. If you would like to provide feedback, please email lwaheed@mtaa.org.au by COB Monday 29 June, including i) the section and line number to be changed, and ii) the specific change you are proposing, with details.
Industry Comments