The Tanzania Medicines and Medical Devices Authority (TMDA) has reminded all registrants, marketing authorisation holders (MAHs), manufacturers, and other stakeholders of their obligation to submit biennial post-marketing surveillance (PMS) reports for registered medical devices and in vitro diagnostics (IVDs).
Registrants must ensure that prescribed biennial PMS reports are prepared and submitted to TMDA within applicable reporting timelines in accordance with the Medical Devices Regulations, 2015 (GN. No. 315), specifically regulation 17(3).
PMS reports must provide adequate information on the quality, safety, and performance of the registered device or IVD. This includes, where applicable: adverse events and incidents; complaints; safety signals identified through post-marketing monitoring; Field Safety Corrective Actions (FSCAs); Field Safety Notices (FSNs); recalls; corrective actions; vigilance information; and other relevant information.
TMDA emphasised that PMS reporting does not replace the separate obligation to promptly report adverse events, incidents, safety signals, FSCAs, recalls, or other reportable events as required under other provisions.
Registrants, MAHs and manufacturers must ensure that submitted information is complete, accurate, current, and sufficient to enable TMDA to effectively assess and take appropriate regulatory actions where necessary.
The authority warned that failure to submit required PMS reports or other mandatory post-marketing safety information may constitute non-compliance and may result in appropriate regulatory action.
Sources
- Primary: Tanzania Medicines and Medical Devices Authority (TMDA) — https://www.tmda.go.tz/announcements/notice-on-submission-of-biennial-post-marketing-su
