An introduction to the Saudi Food and Drug Authority (SFDA) new mandatory Medical Device Interim Regulations (MDIR) and the online application process

Attend BSI’s ‘introduction to the SFDA new mandatory MDIR and the online application process’ one day course and start making informed decisions with regard to meeting the requirements of the SFDA.

On completion of this training course, participants will gain an:

• appreciation of these mandatory regulations
• ability to identify potential commercial impact to their business
• ability to interpret the regulations, to advise the organization on regulatory compliance and fee structure.

Clear guidance will be provided in relation to the on-line application process in order to establish or maintain market authorisation.

On completion of the training participants will be able to:

• explain the background and role of the SFDA Medical Devices sector
• interpret the requirements of the new mandatory medical device interim regulations
• define the process and stages that need to be followed throughout the application
• explain the role and responsibilities of the authorised representative and KSA and non – KSA manufactures
• identify the documents that are required to complete the on-line system application
• appreciate the SFDA post market surveillance requirements
• identify and consider the commercial impacts on the business including fee structure and timescales.