The timelines for the review and approval of medical devices in South Africa can vary depending on several factors, including the class of the device, the completeness of the application, and the workload of the regulatory authority (SAHPRA). However, there are general guidelines for the review and approval process:
1. Class A and Class B devices: These are low to medium-risk devices and typically have shorter review times. The review and approval process for these devices may take approximately 90 to 180 days.
2. Class C and Class D devices: These are higher-risk devices and may require more extensive review, including clinical data. The review and approval process for these devices may take longer, typically between 180 to 365 days or more.
It's important to note that these timelines are approximate and can vary based on the complexity of the device and the completeness of the application. Manufacturers are encouraged to engage with SAHPRA early in the process to understand the specific requirements and timelines for their device registration.
