SFDA calls for developing medical supplies

Saudi Food and Drug Authority (SFDA) has called on those who have the capabilities to develop or manufacture medical devices and products to communicate with it, in order to obtain the requirements and specifications necessary to authorize devices, and what is related to marketing permission, to overcome any challenges or obstacles that might face them.

The Authority stressed the necessity of the developers and manufacturers to comply with their technical and control requirements to obtain an advance approval, in order to ensure that safety and efficiency requirements are met.

The Authority clarified that the technical and regulatory requirements for manufacturing medical devices and supplies include technical standards such as device data to be manufactured, manufacturing and design information, application of the factory quality management system (ISO 13485: 2016), fulfilling basic principles of safety and performance, risk analysis: benefits and risk management, and conformity with relevant specifications, national regulations, product verification and product verification data, which include clinical assessment and biocompatibility, as well as a vigilance and post-marketing monitoring plan. As for the tests needed to manufacture medical devices and products, it must be conducted in accredited laboratories and submit all reports and certificates to the authority. Guidelines and specifications related to the products can be found on the Authority's website.

The authority also confirmed that those interested, including health care providers, companies, researchers, and community members, can contact the authority to obtain support about requirements and specifications through the Regulations and Specifications Section of the Medical Devices and Products Sector via e-mail (md.standards@sfda.gov.sa), as well as in the registration phase and obtaining marketing permission by contacting the Product Registration Support Department (md.rs@sfda.gov.sa) or contacting them through the call center 19999.