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STEP 1 Determine the classification of your product

Determine the classification of your device according to the SFDA classification rules

STEP 2 Appointment of Saudi Authorised Representative (AR)

According to Saudi Arabian medical device regulations, non-local legal manufacturers/applicants are required to appoint an Authorised Representative (AR) company to act as the contact person for the relevant device in Saudi Arabia.The AR will be responsible for product compliance and post-market surveillance.

STEP 3 Preparation of Technical Documents for MDMA Submission

Companies need to conduct a gap analysis of the documents to be submitted according to SFDA requirements. Identifying the gaps is important to determine the studies, reports or statements that must be made.

STEP 4 MDMA Submission

Feedback from the SFDA will not clarify the gaps and steps that need to be taken, they will ask the applicant to resubmit in accordance with the applicable guidance. Applicants typically have a limited number of opportunities to respond to these questions and a window of time to do so.

STEP 5 MDMA Approval

Once granted by the SFDA, the licence owner (always the legal manufacturer) can ship the goods to Saudi Arabia and meet all the requirements necessary for SFDA clearance at the Saudi port.