ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

17^th August, 2026

NOTICE ON SUBMISSION OF BIENNIAL POST - MARKETING SURVEILLANCE (PMS) REPORTS FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTICS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) wishes to remind all registrants, Marketing Authorization Holders (MAHs), manufacturers, and other relevant stakeholders on their obligation to comply with the Post-Marketing Surveillance (PMS) reporting requirements applicable to registered medical devices and in vitro diagnostics (IVDs).
2. Pursuant to regulation 17(3) of the Medical Devices Regulations, 2015 (GN. No. 315), every registrant is required to submit biennial PMS reports to TMDA, including information on adverse events and incidents associated with registered medical devices or IVDs.
3. Accordingly, all registrants of medical devices and IVDs are required to ensure that the prescribed biennial PMS reports are dully prepared and submitted to TMDA within applicable reporting timelines in accordance with the requirements of the Regulations.
4. PMS reports shall provide adequate information on the quality, safety, and performance of the registered device or IVD, including, 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.
5. Registrants and manufacturers are urged to review their PMS obligations and ensure timely submission of all outstanding and subsequent reports. It should be noted that PMS reporting does not replace the obligation to promptly report adverse events, incidents, safety signals, FSCAs, recalls, or other reportable events as separately required.
6. Registrants, MAHs and manufacturers must ensure that the information submitted is complete, accurate, current, and sufficient to enable TMDA to effectively assess and take appropriate regulatory actions where necessary.
7. Failure to submit required PMS reports or other mandatory post-marketing safety information, may constitute non-compliance and may result in appropriate regulatory action to be taken by the Authority.
8. For further information or clarification, stakeholders are advised to contact or visit TMDA Headquarters in Dodoma or the nearest TMDA Zone Office as highlighted hereunder.

Name	Address	Regions served
Eastern Lake Zone	Nyasaka Road, Nyakato Buzuruga, P.O. Box 543, Ilemela, Mwanza, Tanzania Telephone: +255 28 2981224/5 E-mail: info.mwanza@tmda.go.tz	1.Mwanza 2.Mara 3.Simiyu
Southern Highlands Zone	NHIF Tower, 3rd Floor, P. O BOX 6171, Mbeya, Tanzania Telephone: +255 25 250 4425 E-mail: info.mbeya@tmda.go.tz	1.Mbeya 2.Njombe 3.Rukwa 4.Songwe
Northern Zone	Makongoro and Goliondoi Road, P.O. Box 16609, Arusha, Tanzania Telephone: +255 (27) 2970333, +255 737 782442, E-mail: info.arusha@tmda.go.tz	1.Arusha 2.Kilimanjaro 3.Manyara
Eastern Zone	Mandela Road, Mabibo – External, P.O. Box 31356, Dar es salaam, Tanzania Telephone: +255 737 226328 / +255 766 368412 / +255 788 470312 E-mail: info.easternzone@tmda.go.tz	1.Dar es Salaam 2.Coast 3.Tanga
Central Zone	Old Dar es Salaam Road, Plot No. 2D, Block 407, 3rd Floor, P.O. Box 163, Morogoro, Tanzania Telephone:023 261 5491 E-mail: info.morogoro@tmda.go.tz	1.Morogoro 2.Dodoma 3.Iringa 4.Singida
Southern Zone	NBC Building, 1st floor, Serengeti Road, P. O BOX 48, Ruvuma, Songea, Tanzania Telephone: +255 766729416 E-mail: info.ruvuma@tmda.go.tz	1.Ruvuma 2.Lindi 3.Mtwara
Western Zone	NSSF Akiba Commercial Complex, Jamhuri Street, 1st floor, Wing A, P.O Box 520, Tabora, Tanzania Telephone: +255 (26) 2606082 E-mail: tabora@tmda.go.tz	1.Tabora 2.Kigoma 3.Katavi
Western Lake Zone	Nyerere Road, Central Gold Market, Geita Town Council P.O. Box 240, Geita, Tanzania Mob: +255 654 817 849 Telephone: +255 (26) 2606082 Email: geita@tmda.go.tz	1.Geita 2.Kagera 3.Shinyanga