Vigilance and Post Marketing Surveillance
Mrs. Mary M. Masanja Acting Manager, Vigilance and Post Marketing Surveillance
Introduction
The Vigilance and Post Marketing Surveillance (MDV) section is under the Directorate of Medical Devices and Diagnostics which deals with monitoring of safety and performance of medical devices, in vitro diagnostics, laboratory equipment, medical gases, blood and blood products after they have obtained marketing authorization or permitted to enter in the Tanzania Mainland for use.
Vigilance of medical products involve monitoring of Adverse Events and Adverse Incidents according to the Tanzania Medicines and Medical Devices Act, Cap 219 and the Tanzania Medicines and Medical Devices (Control of Medical Devices) Regulations, 2015.
Medical device events/incidents can be reported by health care institutions, health professionals, caregivers, importers, suppliers, manufacturers, Public Health Programs, patients/ consumers and technicians maintaining medical devices/in vitro diagnostics.
Users are encouraged to report all adverse events/incidents as soon as possible. The adverse events/incidents should be reported within the proposed timelines of 24 hours and 30 days for serious event and other events/incidents respectively. Manufacturers are required by law to submit biennial PMS report of the respective device including any adverse events.
Personnel
The section is headed by a Manager who leads the team of five (5) full time officers. The section is made of qualified and experienced experts from the fields of pharmacy, public health, microbiologist, biotechnology innovation and regulatory sciences.
The section collaborates with eight (8) TMDA zonal offices in conducting its activities and other sections within the directorate such as medical devices assessment and premises licensing and compliance particularly if there is quality, safety or performance issues to be addressed where regulatory actions need to be undertaken.
The section also collaborates with the Authority’s Communication and Public Education Section in sensitizing the public on issues related to quality, safety and performance of medical devices using different social media platforms.
Duties and Responsibilities of the Section
A. Vigilance
- Conducting vigilance of medical devices, in vitro diagnostics, laboratory equipment circulating on the market and vigilance of medical gases;
- Conducting haemovigilance of blood and blood products in the country;
- Receives and assess adverse events, incidents and field safety reports associated with the use of medical devices, diagnostics, laboratory equipment, medical oxygen, blood and blood products; and
- Providing Tanzanians with science-based medical information they need to make informed choices/decisions.
B. Post Marketing Surveillance
- Coordinate the collection of samples of medical devices, diagnostics and laboratory equipment from the market for laboratory investigations. These include pre-distribution lot to lot laboratory testing of selected critical medical devices and diagnostics;
- Conducting post marketing surveillance related to medical devices, diagnostics and laboratory equipment circulating on the market;
- Coordinate the preparation and dissemination of reports on post marketing surveillance related to medical devices, diagnostics and laboratory equipment;
- Development and review of regulations guidelines, manuals, standard operating procedures (SOPs), Information, Education and Communication (IEC) materials and performance standards related to post marketing surveillance of devices;
- Secretariat to TMDA PMS task force;
- Institute appropriate regulatory actions for devices that do not conform to safety requirements these include recalls and/or suspension of marketing authorisation of non-compliant medical devices, diagnostics, laboratory equipment, medical oxygen, blood and blood products from the market; and
- Attend and respond to customer enquiries related to post marketing surveillance of devices.