The fees and costs for the registration of medical devices in South Africa can vary depending on the class of the device and the type of application. SAHPRA publishes a schedule of fees for various regulatory activities, including medical device registration.
As of my last update, the fees for medical device registration in South Africa were as follows:
1. Application Fees: These fees are payable at the time of submission of the application and vary depending on the class of the device. For example, the application fee for Class A devices was around R6,000, while for Class D devices, it was around R30,000.
2. Evaluation Fees: SAHPRA may charge additional fees for the evaluation of technical documentation and other information submitted as part of the application. These fees can vary depending on the complexity of the review.
3. Certificate Issuance Fees: Once the application is approved, there may be additional fees for the issuance of the certificate of registration.
It's important to note that these fees are subject to change, and manufacturers should consult the latest fee schedule published by SAHPRA for the most up-to-date information on fees and costs for medical device registration in South Africa.
For more detailed information, you may want to visit the official website of the South African Health Products Regulatory Authority or speak with Artixio Expert.
