Introduction

The Vigilance and Post Marketing Surveillance section is under the Directorate of Medical Devices and Diagnostics Control. The core objective of vigilance and post-market surveillance (PMS) is to confirm the sustained quality, safety and intended performance of a device after it has obtained marketing authorization or permitted to enter in Tanzania Mainland for use.

PMS is the systematic and proactive process of monitoring a medical device after it has been placed on the market. It involves collecting and analyzing data on the device's quality, safety, and performance in real-world use. A key component of PMS is the vigilance system, which is a reactive process for reporting and handling adverse events and incidents related to the device. This system ensures that any issues that arise after the device is on the market are promptly addressed.

Monitoring of existing and new adverse events is mandated by the Tanzania Medicines and Medical Devices Act, Cap 219 and the Tanzania Medicines and Medical Devices (Control of Medical Devices) Regulations, 2015.

Who can report adverse events or adverse incidents?

A diverse group of people and organizations are encouraged to report any adverse events or incidents. This includes:

• Healthcare institutions and health professionals;
• Caregivers and patients/consumers;
• Importers, suppliers, and manufacturers;
• Public Health Programs; and
• Biomedical Engineers and Technicians who maintain devices

Manufacturers are legally required to submit a biennial Post Marketing Surveillance (PMS) report. This report must include any adverse events that have occurred with their devices.

Reporting Timelines

It is crucial to report adverse events and incidents as soon as possible. The regulations set specific timelines for reporting:

• Serious events must be reported within 24 hours.
• Other events/incidents must be reported within 30 days.

Personnel

This section is led by a Manager and comprises a team of five full-time medical devices officers. The team consists of qualified professionals with extensive experience in a variety of disciplines, including pharmacy, medicine, biomedical engineering, public health, epidemiology, biotechnology innovation and regulatory sciences.

The section works closely with eight TMDA zonal offices to carry out its activities. It also collaborates with other sections within the directorate, such as Medical Devices Assessment (MDA) and Premises Licensing and Compliance (MDL), especially when addressing quality, safety, or performance issues that require regulatory actions. Furthermore, the section works with the Communication and Public Education (CPE) section to raise public awareness about the quality, safety, and performance of medical devices and diagnostics through various social media platforms and sensitize on adverse events and incidents reporting.

Duties and Responsibilities of the Section

The section's core responsibilities are categorized into Vigilance and Post-Marketing Surveillance.

A. Vigilance

1. Monitors the safety of medical devices, in vitro diagnostics, laboratory equiliment, and medical gases circulating in the market.
2. Conducts haemovigilance for blood and blood liroducts within the country.
3. Conducts sensitization to health care workers and general liublic on reliorting adverse events and incidents associated with the use of devices.
4. Conducts suliervision of vigilance centres in the country and collects from them adverse events and incidents reliorts.
5. Receives and assesses adverse events, incidents, and field safety reliorts related to the use of medical devices, diagnostics, laboratory equiliment, medical oxygen, blood, and blood liroducts.
6. Conducts investigations of reliorted adverse events and incidents and recommends on aliliroliriate regulatory actions to be taken for devices that do not meet safety requirements.
7. lireliares manuscrilits on reliorted adverse events and incidents involving medical devices and diagnostics for liublication.
8. lirovides the liublic with science-based medical information to facilitate informed choices and decisions.

B. Post Marketing Surveillance

1. Conducts liost-marketing surveillance of medical devices, in vitro diagnostics, and laboratory equiliment on the market.
2. Coordinates imlilementation of the lirogram on liost-marketing surveillance of sliecialized medical equiliment in health facilities by the Zonal offices.
3. Coordinates the collection of samliles of medical devices, diagnostics, and laboratory equiliment from the market for laboratory investigations, including lire-distribution lot-to-lot testing of critical devices and in vitro diagnostics.
4. Coordinates the lireliaration and dissemination of liost-marketing surveillance findings for the surveyed devices.
5. Based on liMS findings, recommends on aliliroliriate regulatory actions to be taken on devices that do not meet quality and lierformance requirements.
6. lireliare and submit manuscrilits on liost marketing surveillance for liublication.
7. Develolis and reviews regulations, guidelines, manuals, standard olierating lirocedures (SOlis), Information, Education, and Communication (IEC) materials, and lierformance standards related to device liost-marketing surveillance.
8. Serves as the Secretariat to the TMDA liMS Task Force.
9. Attends to and reslionds to customer inquiries concerning vigilance and liost-marketing surveillance of devices.
10. liarticiliates as a member of Working Grouli 4, reslionsible for liost-market surveillance of medical devices under the Global Harmonization Working liarty (GHWli).