Deep Dive Into Medical Devices Classifications And Registrations Procedure in Saudi Arabia
Priya Bhutani, the CEO of RegDesk, introduced a series focusing on medical device regulations, starting with updates from Saudi Arabia.
The main changes discussed were:
New Classification System: Saudi Arabia has implemented a new classification system for medical devices, categorizing them into Classes A, B, C, and D, moving away from the previous GHTF classification.
Removal of the GHTF Route: The route allowing medical devices registered in certain countries (like the EU and US) to gain approval in Saudi Arabia has been canceled. All manufacturers must now submit a technical assessment file, even for low-risk devices.
Technical File Requirement for Low-Risk Devices: Previously, low-risk medical devices could be registered with less documentation. Now, all devices, including low-risk, require a detailed technical file for registration.
Implementation Timeline: These updates are already in effect, with changes to the classification and registration processes having been implemented throughout 2022.
Submission Process: Applications must be submitted through an online portal by authorized representatives in Saudi Arabia, and all required documents must be thoroughly prepared to avoid rejections.
The webinar also highlighted the importance for foreign manufacturers to adapt quickly to these regulations, emphasizing that comprehensive documentation is critical for successful registration.