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AFRICA

RWANDA

 

RWANDA

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Global   >   Africa    
Market Information

Rwanda's healthcare expenditure 

Market Trend: 

 

Rwanda’s medical equipment market 

Market Info
Classification, Fees, Timeline
Classification
Product Registration Routes

Class I, IIa, IIb, III, AIMDs 

All Medical Devices need to have an appointed European Authorised Representative to export their devices to Europe, and vice versa. The devices have to be in compliance with the Medical Device Ordinance (MedDo). The devices need to be affixed with the Unique Device Identifiers (UDI) according to the timelines,

- from 26 May 2021 for implantable devices and Class III devices

- from 26 May 2023 for Class IIa and IIb devices

- from 26 May 2025 for Class I devices 

- 2 years after the dates given letters a-c for the relevant product class for reusable devices 

Registration
Useful Information

Validity of License: 5 years 

 

License transfer: Change of Registration application needed.

 

Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.

Quality System: ISO 13485:2016

Useful Info

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