Medical Device Regulation

The Medical Devices Regulation Directorate is responsible for the regulation of medical devices and in-vitro diagnostic devices intended for use in the diagnosis, prevention, monitoring, treatment, or alleviation of diseases and medical conditions. The Directorate ensures that medical devices placed on the Zambian market are safe, effective, and perform as intended.

The Directorate reviews applications for registration, assesses technical documentation, evaluates product performance and safety data, and conducts post-market surveillance activities. It also oversees the importation, distribution, and use of medical devices within the country. Through these regulatory activities, ZAMRA promotes access to quality medical technologies while protecting patients, healthcare professionals, and the public from potential risks associated with medical devices.