Saudi Arabia The Saudi Food and Drug Authority (SFDA) has adopted an implementing rule regarding the requirements for Quality Management System (QMS) Auditing Organizations. The document is based on the Medical Devices Interim Regulation and is intended to clarify and specify the...
Saudi Arabia The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published a guidance dedicated to the requirements for medical masks and particulate respirators – the medicinal products that become vitally important in the context of the COVID-19. The document also...
Saudi Arabia The Saudi Food and Drug Authority (SFDA), Saudi Arabia`s medical device regulating authority, has published a guidance document on requirements of shipments clearance at ports of entry. The document is intended to provide additional information on compliance matters...
Saudi Arabia The Saudi Food and Drug Authority (SFDA), the country’s regulating authority, has published a guidance document dedicated to the requirements for electronic instructions for use (eIFU) of medical devices. The document was initially published on August 22, 2019, for...
Saudi Arabia The Saudi Food and Drug Authority (SFDA), Saudi Arabia`s authority for medical devices regulation, issued guidance dedicated to the field safety corrective actions. Regulatory Background The present SFDA guidance is intended to provide additional information and...
Saudi Arabia The Saudi Food & Drug Authority, the agency responsible for medical device regulation in the Kingdom of Saudi Arabia, issued draft guidance dedicated to the classification of the combination products. The document will be available for public comments since the...
