REGULATORY AUTHORITY: Medical devices are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare (MHLW).
CLASSIFICATION SYSTEM: Devices are classified according to risk into Classes I, II, III and IV.
TIMEFRAME: The registration process ranges from 8-16 months, depending on classification.
SPECIAL REQUIREMENT: Local testing or clinical study is not required.
LOCAL FEES (New application):
Medical Devices
Class A – USD 500
Class B – USD 1500
Class C – USD 2000
Class D – USD 2500
In-vitro Diagnostics (IVDs)
Class A – USD 300
Class B – USD 1000
Class C – USD 1200
Class D – USD 1500
LOCAL FEES (Manufacturer):
An on-site inspection will be required for a foreign manufacturing facility. In special circumstances, however, the authority may conduct a virtual/remote inspection instead.
GMP Inspection fees for a maximum 5 production lines at one site:
Facility located in East Africa – USD 3,000
Facility located in Rest of Africa – USD 4,000
Facility located in Asia – USD 5,000
Facility located in Europe – USD 6,000
Facility located in America – USD 7,000
Facility located in Australia and New Zealand – USD 6,000
(Extra USD 1000 for every additional production line)
LICENSE VALIDITY:
GMP Inspection fees for a maximum 5 production lines at one site:
Facility located in East Africa – USD 3,000
Facility located in Rest of Africa – USD 4,000
Facility located in Asia – USD 5,000
Facility located in Europe – USD 6,000
Facility located in America – USD 7,000
Facility located in Australia and New Zealand – USD 6,000
(Extra USD 1000 for every additional production line)
LICENSE TRANSFER:
License transfer is possible and considered as major variation.
AUTHORIZED REPRESENTATIVE:
Foreign manufacturer must appoint a local technical representative (LTR) who must be a company incorporated in Rwanda and authorized by Rwanda FDA and must hold operating license.
ADDITIONAL INFORMATION:
When the market authorization is approved, the registration certificate will be issued. There are 2 types of certificates: full and conditional registration certificate. A conditional certificate will be issued to devices in which there are certain conditions must be fulfilled by marketing authorization holder to acquire a full certificate.
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
