Guidelines

Guidance on Importation Requirements for Medical Devices and Non-Medical IVDs Intended for Educational or Non-Clinical Research Purpose

Guidance on Importation Requirements of Non-Medical In-Vitro Diagnostics

Guidance on Innovative Medical Devices (MDS – G002)

Guidance on International Quality and Efficiency Samples

Guidance on Manufacturing Paths of Medical Devices (MDS-G011)

Guidance on MDMA –Significant and Non-Significant Changes (MDS-G012)

Guidance on Medical Devices Classification (MDS – G008)

Guidance on Medical Devices Samples Collection (MDS-G013)

Guidance on Publication of Public Assessment Reports for Medicinal Products for Human Use (Saudi-PAR)

Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives

Guidance on Saudi Food and Drug Authority Policy for Collection of Patient Experience Data (MDS-G018)

Guidance on Saudi Food and Drug Authority Policy for Engagement with Healthcare Practitioners (MDS-G017)