The Republic of Zambia is a landlocked country in south-central Africa. Market access for medical devices in Zambia is subject to regulatory approval by the Zambia Medicines Regulatory Authority (ZAMRA).
This article provides a concise overview of the classification, registration pathway, and key regulatory requirements for importing medical devices into Zambia.
Medical Device Classification
According to Zambian regulations, medical devices are classified into four risk-based categories (Classes A, B, C, and D), with regulatory control increasing in proportion to the level of risk.
Basic Registration Pathway
All imported medical devices must be registered with ZAMRA prior to being placed on the Zambian market. Applicants are required to appoint a Local Responsible Person (LRP) established in Zambia.
Registration applications must be submitted using ZAMRA-designated application forms and accompanied by a complete technical dossier in English.
Documentation Requirements
- Class A (Non-IVD Medical Devices):
(Image) - Class B, C, and D Medical Devices:
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Review Timeline and Registration Validity
- Review Timeline:
All applications are assessed in the order received and should be evaluated within 180 working days from the date of submission. - Registration Validity:
Approved registrations are valid for five (5) years and are subject to renewal upon expiry.
If you require assistance with medical device registration in Zambia or related regulatory matters, please feel free to contact us.