Post - Market Surveillance (PMS)
Post - Market Surveillance (PMS)
In accordance with the Tanzania Medicines and Medical Devices (Control of Medical Devices) Regulations, 2015 and the Guidelines for Medical Devices Vigilance System in Tanzania, manufacturers are legally required to submit a biennial Post-Market Surveillance (PMS) report. This report must include information on any adverse events associated with their medical devices.
PMS is a critical, continuous, and proactive process that ensures the quality, safety, and performance of medical devices after they are placed on the market. It involves the ongoing collection, analysis, and interpretation of data from various sources to detect and address potential issues early.
Manufacturer Responsibilities
Manufacturers play a central role in PMS by implementing a comprehensive Quality Management System (QMS). Their responsibilities include:
- Collecting and analyzing post-market data
- Handling complaints and performing root cause analyses
- Implementing Corrective and Preventive Actions (CAPAs)
- Taking immediate action to mitigate risks when safety concerns arise
Actions may include updating device design, revising manufacturing processes, issuing new instructions for use, or initiating field safety corrective actions or product recalls.
TMDA’s Role
TMDA oversees and enforces the PMS regulatory framework to ensure ongoing public health protection. TMDA actively conducts market surveillance and operates two PMS programs, each on a three-year cycle:
- Single-use Devices and In Vitro Diagnostics Program
- Focuses on monitoring the quality and performance of selected products in circulation in Tanzania;
- Medical Equipment Surveillance Program
- Assesses the quality, safety, and performance of medical equipment installed in both public and private healthcare facilities.