Saudi Arabia (KSA)
The Saudi Food & Drug Authority (SFDA) is the authority responsible for medical device vigilance and quality control. The Saudi medical device classification system may be based on either that of the EU, Australia, USA, Japan or Canada. The validity of your registration in the KSA follows the validity of the registration where your SFDA registration is based upon. About 10 years ago the SFDA issued a Medical Devices Interim Regulation (MDIR) and in addition launched an electronic system, the Medical Devices Marketing Authorization System (MDMA), to authorize medical devices after they comply with the MDIR.
The manufacturer must provide evidence, as required, that the quality management system is in place and that is covers the appropriate processes and is subject to independent audits.
Local license holder
Companies without an establishment in Saudi Arabia are required to appoint a local authorized representative. Only companies that hold a valid establishment license, issued by the SFDA, and with a written mandate from the foreign manufacturer are allowed to act on their behalf. The mandate established between the manufacturer and the authorized representative shall be in writing, specify the mandated activities and be subject to the laws of the KSA.
The language of the submission files shall be either in the English or Arabic language. Labeling should be in Arabic unless the device is only used by professionals, in that case English is sufficient.