Medical Device Registration and Approval in Rwanda

General country-specific regulatory information is provided on this page for medical device registration and approval in Rwanda.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in Rwanda

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.

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For detailed device-specific compliance information for each market, including Rwanda, to expedite the preparation of your medical device or IVD registration application.

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And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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