The 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 the Authority to set up the mechanism for developing these products. The Authority needs to be approached to get the requirements and specifications necessary to authorize the devices and also the necessary marketing permission for their products. This would help them overcome any challenges or obstacles that they might face. The Authority stressed the necessity of the developers and manufacturers to comply with their technical and quality control requirements in order to obtain advance approval and 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 they should 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 details about the requirements and specifications needed. The details about the requirements and specifications can be had through the Regulations and Specifications Section of the Medical Devices and Products Sector via e-mail ([email protected]), as well as in the registration phase and obtaining marketing permission by contacting the Product Registration Support Department ([email protected]) or contacting them through the call center 19999. — SPA
