2019年 9月 4日
Medical device market regulators in Saudi Arabia plan to raise registration fees as well as implement a new device regulatory system in the coming months.
According to updated guidance issued by the Saudi Food and Drug Authority (SFDA), the fee increase for Medical Device Marketing Authorization (MDMA) is set to take effect October 1, 2019, followed by implementation of a new regulatory system in early 2020. If implemented as planned, the new fees would mean an increase of between roughly USD $3,000 to $8,000 per application.
The new fees will be based on the number of devices and/or accessories included in an MDMA application, whereas currently fees are assessed according to device risk class as well as leveraged reference market.
Emergo by UL sources in Riyadh also report that the updated guidance also indicates that the Saudi government plans to go through with establishing a new regulatory system for medical devices as early as January 2020.
The new SFDA requirements will include a new risk classification system for devices, which may result in manufacturers no longer being able to leverage reference markets such as the European Union or US to obtain registration in Saudi Arabia. Emergo by UL consultants will provide additional details on this new regulatory system as we learn them.
Finally, SFDA has set a 60-calendar-day deadline for MDMA applicants to respond to inquiries from the regulator or from Conformity Assessment Bodies. Applicants needing additional time to address issues should provide justifications to SFDA. Otherwise, failure to meet the 60-day deadline will result in SFDA deleting the MDMA application in question.
This new deadline may reduce overall SFDA review and approval timeframes for MDMA applicants, although some companies will be challenged to meet these requirements.