Biennial Post-Marketing Surveillance Reports for Devices in Tanzania

1. Key takeaways

On 17 August 2026, TMDA issued the public notice Notice on Submission of Biennial Post-Marketing Surveillance (PMS) Reports for Medical Devices and In Vitro Diagnostics (published on the website on 5 October 2026). This is the most consequential post-market compliance document for Tanzania in the past two years.

The key points of the notice:

1. Legal basis: it cites Regulation 17(3) of GN 315 — every registrant must submit a biennial PMS report to TMDA containing adverse events and incident information relating to registered devices or IVDs.
2. Duty holders: registrants, marketing authorization holders (MAHs), manufacturers and other stakeholders.
3. Report content (enumerated in the notice): adequate information on quality, safety and performance, including 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.
4. Key limitation: PMS reporting does not replace the obligation to promptly report adverse events, incidents, safety signals, FSCAs, recalls or other reportable events.
5. Consequences: failure to submit the required PMS reports or other mandatory post-market safety information may constitute non-compliance and may lead to appropriate regulatory action by TMDA.

2. Legal basis

3. Expert insights

Insight one: the coexistence of biennial and biannual in the official texts is the single most important terminology risk in this file.

Regulation 17(3) of GN 315 uses biennial (every two years); the 2024 Compendium Part I §5.1(b) uses biannual (a word that can mean either twice a year or every two years in English, and is genuinely ambiguous); while the title and body of the TMDA notice of 17 August 2026 both use biennial.

The GRZAN working position is to follow the statute, Regulation 17(3), and the 2026 notice, both of which say biennial — that is, once every two years — while seeking written confirmation from TMDA and noting in external documents that the official texts contain both spellings. Never self-interpret the term as twice a year and double the reporting cadence on that basis.

Insight two: the notice lists nine categories of report content, far broader than the usual understanding of an adverse event summary.

The notice requires PMS reports to 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.

Of the nine categories, complaints and safety signals are the two most frequently omitted — companies tend to summarize only the adverse events already reported and leave complaint data inside the quality system, where it never reaches the regulator.

Insight three: the sentence that PMS reporting does not replace immediate reporting is the most practically valuable sentence in the notice.

The notice states: 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.

Two obligation tracks therefore run in parallel: individual case reporting follows the 24-hour, 14-day and 30-day timelines of Regulations 41–44, while periodic summarization follows the biennial PMS report of Regulation 17(3). Submitting a PMS report does not excuse a late individual report, and the reverse holds equally.

Insight four: failure to submit PMS reports is a freestanding ground for suspension or cancellation, and Regulation 18 adds two related grounds.

Regulation 18(h): failure by a registrant to submit PMS reports as required permits suspension or cancellation of the registration. Regulation 18(i): failure by a registrant, willfully and without reasonable cause, to submit reports on adverse effects likewise permits suspension or cancellation. Together with the retention fee default in Regulation 18(g), three of the grounds in Regulation 18 are pure omissions of administrative action — this is the largest post-certification compliance risk zone in Tanzania.

Insight five: the PMS report is also renewal material.

Part I §3.3.3(d) lists Post Marketing Surveillance Reports among the five items required for a renewal application. A biennial PMS cycle therefore yields at least two to three reports across a five-year registration, and the most recent one must be able to support the renewal file at the moment it is filed.

4. Practical recommendations

1. Build a PMS data aggregation mechanism covering the nine enumerated categories, and make sure the complaint register and safety signal identification records are included.
2. Run PMS reporting and individual vigilance reporting as two separate processes with two separate registers, with no offsetting between them.
3. Schedule on a two-year cycle and ensure the most recent report is complete before renewal.
4. Obtain written confirmation from TMDA once on the meaning of biennial and retain the reply.
5. Add failure to submit PMS reports to the annual internal red-line review (Regulation 18(h)).

5. Verification checklist

• □ It is understood that the legal basis for PMS reports is Regulation 17(3) of GN 315 and that the latest notice is dated 17 August 2026.
• □ Report content covers the nine enumerated categories (including complaints and safety signals).
• □ PMS and individual vigilance run as two independent processes.
• □ A two-year schedule exists, with the most recent report complete before renewal.
• □ The meaning of biennial has been confirmed with TMDA in writing (the official texts contain both biannual and biennial).
• □ Failure to submit PMS reports is listed among the annual compliance red lines (Regulation 18(h)).

Regulatory information verified as of 29 October 2026. All content cited in this document was checked against the TMDA public notice of 17 August 2026, GN. No. 315 Regulations 17(3), 18(h) and 18(i), and the June 2024 Compendium Part I §5.1(b) and §3.3.3(d), and will be re-reviewed when the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate a licensed Local Responsible Person (LRP) and distributor resources, covering online submission, sample delivery, quality audit support, and port clearance.
• Service capabilities: classification determination, route selection between registration and notification, technical documentation (CSDT/STED) preparation and localization, GMDN coding and grouping strategy, clinical evidence organization, software and AI-enabled device submissions, change management, vigilance and PMS reporting, and annual retention fee and renewal management.
• Contact GRZAN for registration documentation and conformity support for the Tanzania market: info@grzanglobal.com.