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Market Information
Rwanda's healthcare expenditure from 2022-2023 Rwanda's health sector budget amounted to FRW 365.2 billion, reflecting an 18% decrease. Domestic resources accounted for 51.1% of the budget, with the remainder funded through external support.
Market Trend: Rwanda's medical device market is projected to grow at a Compound Annual Growth Rate (CAGR) of 7–10%, driven by rising healthcare investments and demand for advanced technologies. Currently, medical device spending in Rwanda is estimated at $1–$2 per capita, highlighting a developing market reliant on imports and donor support.
Rwanda’s medical equipment market : Rwanda’s medical equipment market amounts to $54.2 million in 2022, with an anticipated growth rate exceeding 7% over the period from 2022 to 2027.
The Rwanda Food and Drugs Authority (RFDA) was established to regulate medical devices, including in vitro diagnostics (IVDs), under the Rwanda Medicines and Medical Devices Policy. All medical devices must be approved by the RFDA before being supplied in Rwanda.
Classification, Fees, Timeline
Product Registration Routes
Class I, Class II, Class III
Domestic Manufacturers Route
Importation Route
EU/CE-Marked Devices Route
Pre-Market Notification Route
Fast-Track Route
Useful Information
Validity of License: 1-3 years
License transfer: The transfer of a medical device registration license from one company to another is possible but requires the approval of the RFDA.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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