- This event has passed.
Regulatory Information Session on the Detention of Medical Devices and In Vitro Diagnostics (IVDs) at Ports of Entry
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with key regulatory authorities, invites manufacturers, importers, distributors, authorised representatives, industry associations and other stakeholders to attend a Regulatory Information Session on the Detention of Medical Devices and In Vitro Diagnostics (IVDs) at Ports of Entry.
This webinar will provide stakeholders with an opportunity to engage directly with regulators on common challenges relating to the detention of medical device and IVD consignments at ports of entry, including documentation requirements, product classification, inspection processes and coordination between authorities.
What to Expect
- Clarification of the roles and responsibilities of authorities involved in the importation and clearance of medical devices and IVDs.
- Discussion of common reasons for the detention of consignments and approaches to addressing these challenges.
- Engagement on matters relating to medical devices composed of human tissues.
- Guidance on product classification and applicable regulatory requirements.
- Industry experiences, practical insights and opportunities for improvement.
- Discussion on strengthening communication, coordination and regulatory harmonisation among
Register here: https://bit.ly/4k7d0DR
We are looking forward to your attendance!