REGULATORY AUTHORITY
Medical devices are regulated by the Rwanda Food and Drugs Authority (Rwanda FDA) under the Ministry of Health.
CLASSIFICATION SYSTEM
Medical devices: Class A, B, C, and D.
IVDs: Class A, B, C, and D.
TIMEFRAME
Medical devices: 8–16 months, depending on classification and registration pathway.
IVDs: 8–16 months, depending on classification and registration pathway.
LICENSE VALIDITY
- Notification Certificate: Valid for 3 years.
- Registration Certificate (Conditional): Valid for a period specified in the certificate, up to 3 years.
- Registration Certificate (Full): Valid for 5 years from the date of issuance.
- GMP Certificate:
- Desk review: 3 years
- On-site inspection: 5 years
LOCAL FEES (New Application)
Medical devices – Flat fee based on origin of reference approval:
- EAC: USD 100
- SRAs / WLAs: USD 400
- Other jurisdictions: USD 600
IVDs – Flat fee based on origin of reference approval:
- EAC: USD 100
- SRAs / WLAs: USD 150
- Other jurisdictions: USD 200
GMP INSPECTION
GMP inspection fees are included in the registration fees. The Authority may conduct desk-based, remote, or on-site inspections, depending on the regulatory pathway and reliance eligibility.
LICENSE TRANSFER
License transfer is possible and is considered a major variation, subject to approval by Rwanda FDA.
AUTHORIZED REPRESENTATIVE
Foreign manufacturers must appoint a Local Technical Representative (LTR) that:
- Is incorporated in Rwanda
- Is authorized by Rwanda FDA
- Holds a valid operating license
ADDITIONAL INFORMATION
- Local testing and local clinical studies are not required.
- Registration certificates may be issued as full or conditional approvals.
- Conditional registration is granted when specific post-approval conditions must be fulfilled by the Marketing Authorization Holder.
NOTES
- EAC (East African Community): East African nations with harmonized regulatory frameworks.
- SRAs (Stringent Regulatory Authorities): US FDA, EMA (Europe), MHRA (UK), PMDA (Japan), Health Canada, TGA (Australia).
- WLAs (World Listed Authorities): Authorities aligned with WHO or international standards but not classified as SRAs.
Other Sub-Saharan African Countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar
