| Regulatory Authority | Zambia Medicines Regulatory Authority, ZAMRA |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | A,B,C,D |
| Medical Device Regulations | Medical Device Guidelines (Same Regulations for IVD) | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | Guidelines |
| Device Classification Guidelines |
https://www.zamra.co.zm/wp-content/uploads/2023/08/Guidelines-on-the-Principles-of-Medical-Devices-Classifications-v1.pdf | Click Here |
| Registration Process | GUIDELINES ON APPLICATION FOR GRANT OF MARKETING AUTHORISATION OF NON IN - VITRO DIAGNOSTIC MEDICAL DEVICES FOR HUMAN USE | Click Here |
| Registration Timeline | Class A: 3 to 9 monthsClass B, C, D: 9 to 12 months |
| Conformity Assessment Route |
Essential Principles of Safety and Performance of Medical Devices | Click Here |
| Requirement of Authorized Representative | YES |
| Language Requirement | Labels must be in English Language |
| Labeling Requirements |
Guidelines for Label and Instructions for Use for Medical Devices | Click Here |
| Additional Information | Instructions for use may be provided to the user either in paper or non paper format. |