In Saudi Arabia, the Saudi Food and Drug Administration (SFDA) requires medical device manufacturers to appoint an authorized representative (AR) to conduct business on their behalf in the market. Authorized representatives are responsible for product compliance, safety, after-market obligations, and updates to medical device registrations.
A valid authorized representative's license is required for product marketing and customs clearance. SFDA allows changes to an appointed authorized representative, if needed, without the involvement of a previously appointed authorized representative.
一、What is an Authorized Representative (AR)?
Authorized representatives are the official representatives of medical device manufacturers to the Saudi Food and Drug Administration (SFDA).
二、Who can be an authorized representative in Saudi Arabia?
Authorized representatives must be registered and approved by the SFDA. Authorized representatives must have a venue in Saudi Arabia and have specific permits and qualifications. Here are the most critical requirements:
1、Must be a local company registered in Saudi Arabia with a license to trade medical devices.
2、Must be authorized by SFDA as a medical device institution.
3、Must maintain the quality management system.
4、There must be dedicated staff responsible for safety and regulatory functions.
三、What are the responsibilities of an AR?
1、 Representative of SFDA
Submit marketing authorization requests for MDMA and medical device maintenance.
Actions to implement SFDA requirements.
Provide data on quality, efficacy and safety to SFDA.
2、Post-market Surveillance
Submit adverse events that occur abroad
Submit any corrective action required as a result of ongoing supervision.
Cooperate with other parties responsible for the installation, maintenance and supply of medical equipment.
四、Does Saudi Arabia need to appoint a local authorized representative?
If an overseas medical device manufacturer wants to apply for the MDMA certificate, it must appoint a local individual or entity as its Authorized Representative, sign a formal authorized representative agreement, and the authorized representative will make an official record and obtain an Authorized Representative License.
五、What are the duties of the Saudi authorized representative?
The Saudi authorized representative is the link and bridge between foreign manufacturers and SFDA in Saudi Arabia, and communicates with SFDA on behalf of manufacturers, responsible for helping customers with MDMA registration, UDI application and assisting manufacturers in implementing post-marketing supervision and other matters.
六、Can foreign manufacturers' importers in Saudi Arabia act as their authorized representatives in Saudi Arabia?
Agreed. However, according to Saudi regulations, a device can only be declared MDMA on behalf of a Saudi authorized representative. Multiple declarations of MDMA for the same product are prohibited. Therefore, if a manufacturer has multiple customers in Saudi Arabia, it is recommended that an authorized representative of a third party without importer duties help declare MDMA to avoid adverse competition among local distributors and affect the export business of overseas manufacturers.
七、 Does the manufacturer need the approval certificate of the product in the US/EU/China and other countries to apply for MDMA registration?
If the manufacturer has a device approval certificate from another country, such as an MDD/MDR certificate, 510K Summary, etc., it can be used as a supporting document for MDMA registration, but such documents are not necessary for MDMA registration. The MDMA declaration requires manufacturers to prepare and upload technical documents that meet the requirements of Saudi regulations, which are approved by the SFDA and issued.
