Vigilance and Post Marketing Surveillance
Mr. David R. Matle Manager, Vigilance and Post Marketing Surveillance
David R. Matle is the Acting Manager for Vigilance and Post Marketing Surveillance of medical devices and diagnostics at the Tanzania Medicines and Medical Devices Authority (TMDA) headquarters in Dodoma.
After earning a Bachelor of Pharmacy degree from the University of Dar es Salaam in 2001, Mr. Matle started his career as a Hospital Pharmacist at Muhimbili National Hospital. For three years, he served as the Head of the Maternity Block Pharmacy before moving to the Tanzania Food and Drugs Authority (TFDA), the predecessor to TMDA, in 2007 as a Drug Registration Officer.
In 2013, Mr. Matle was seconded to the East African Community (EAC) Secretariat as the National Medicines Regulation Officer for Tanzania Mainland, where he contributed to the EAC Medicines Regulatory Harmonization (MRH) Programme. While serving in this role, he earned a Master of Science in Biotechnology Innovation and Regulatory Sciences (BIRS) from Purdue University, USA in 2017. He concluded his service with the EAC Secretariat in June 2017 and rejoined TFDA (now TMDA) in June 2018.
Mr. Matle is a registered Pharmacist with the Pharmacy Council of Tanzania and a member of the Pharmaceutical Society of Tanzania and is actively participated in Global Harmonization Working Party (GHWP) initiatives.
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.
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
- Monitors the safety of medical devices, in vitro diagnostics, laboratory equipment; and medical gases circulating in the market.
- Conducts haemovigilance for blood and blood products within the country;
- Conducts sensitization to health care workers and general public on reporting adverse events and incidents associated with the use of devices;
- Conducts supervision of vigilance centres in the country and collects from them adverse events and incidents reports;
- Receives and assesses adverse events, incidents, and field safety reports related to the use of medical devices, diagnostics, laboratory equipment, medical oxygen, blood, and blood products;
- Conducts investigations of reported adverse events and incidents and recommends on appropriate regulatory actions to be taken for devices that do not meet safety requirements;
- Prepares manuscripts on reported adverse events and incidents involving medical devices and diagnostics for publication;
- Provides the public with science-based medical information to facilitate informed choices and decisions.
B. Post Marketing Surveillance
- Conducts post-marketing surveillance of medical devices, in vitro diagnostics, and laboratory equipment on the market;
- Coordinates implementation of the program on post-marketing surveillance of specialized medical equipment in health facilities by the Zonal offices;
- Coordinates the collection of samples of medical devices, diagnostics, and laboratory equipment from the market for laboratory investigations, including pre-distribution lot-to-lot testing of critical devices and in vitro diagnostics;
- Coordinates the preparation and dissemination of post-marketing surveillance findings for the surveyed devices;
- Based on PMS findings, recommends on appropriate regulatory actions to be taken on devices that do not meet quality and performance requirements;
- Prepare and submit manuscripts on post marketing surveillance for publication;
- Develops and reviews regulations, guidelines, manuals, standard operating procedures (SOPs), Information, Education, and Communication (IEC) materials, and performance standards related to device post-marketing surveillance;
- Serves as the Secretariat to the TMDA PMS Task Force;
- Attends to and responds to customer inquiries concerning vigilance and post-marketing surveillance of devices;
- Participates as a member of Working Group 4, responsible for post-market surveillance of medical devices under the Global Harmonization Working Party (GHWP);