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Rwanda FDA · Middle East & Africa

Rwanda medical device regulatory resources

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5 free resources24/25 topics with records4 regulations trackedSep 2026 fees reviewed
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AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Rwanda requirements.

Government registration fees

Review current Rwanda FDA application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Medical device regulations

Browse Rwanda's official medical-device instruments — the regulations and guidelines governing registration of medical devices and IVDs, the reliance guideline, and the fee regulations — with citeable English, French and Kinyarwanda passages.

Structured regulatory requirements

Explore all 29 source-linked facts →

24 of 25 research dimensions currently covered · 12 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
Rwanda FDA is the competent authority for medical devices and IVDs
The Rwanda Food and Drugs Authority (Rwanda FDA) is a regulatory body established by Law No 003/2018 of 09/02/2018. One of its functions is to regulate matters related to the quality, safet…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Law No 003/2018 article 9, the device registration regulations DFAR/HMDAR/TRG/002, and guideline DHT/GDL/024
The legal basis is Law No 003/2018 of 09/02/2018 establishing Rwanda FDA and determining its mission, organisation and functioning, under which the technical regulations DFAR/HMDAR/TRG/002…
1 source-linked fact
Checked 2026-09-16
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D03

Device definition & scope

Verified
The regulations cover all human and veterinary medical devices including IVDs submitted for marketing authorisation
The registration regulations apply to all regulated human and veterinary medical devices including in vitro diagnostics submitted for marketing authorisation, and they cover the full device…
1 source-linked fact
Checked 2026-09-16
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D05

Registration pathways

Verified
Three device routes: notification (Class A), abridged assessment, full assessment
Rwanda FDA processes medical device applications through three routes. Notification applies to Class A devices that are non sterile, non active and without a measuring function, and results…
1 source-linked fact
Checked 2026-09-16
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D06

Reliance & recognition

Verified
Abridged assessment route taking account of prior assessment and inspection outcomes from WHO prequalification or a competent NRA, on a sameness declaration with SRA / WHO PQ / EAC registration
statement: Rwanda FDA operates an abridged assessment procedure for medical device registration. Abridged assessment is defined as a limited independent assessment of specific parts of the…
Expedited review for devices registered in countries that have signed a memorandum of understanding with Rwanda FDA
statement: The same 'Expedited Review Documentation' section of the device registration guideline applies to devices registered in countries with which Rwanda FDA has signed a memorandum of…
6 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Applications may be filed by the applicant, the manufacturer or a Local Technical Representative registered in Rwanda
An application for registration or notification of a medical device or IVD is made to the Authority in writing by the applicant, the manufacturer or a Local Technical Representative. A Loca…
1 source-linked fact
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Importation reserved to licensed importers or exhaustively listed eligible importer categories
Rwanda FDA guidelines reserve the importation of medical devices/IVDs to importers whose premises are licensed by the Authority or who fall within an eligible importer category, and the eli…
1 source-linked fact
Checked 2026-09-16
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D09

Dossier requirements

Verified
Registration dossier uses a Table of Contents format with a declaration of conformity and an essential-principles checklist
A registration application (as opposed to a notification) comprises a cover letter to the Director General, the registration application form, a technical documentation / technical file in…
1 source-linked fact
Checked 2026-09-16
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D10

Official forms & portals

Verified
Applications are received only through the Rwanda FDA online portal
An application for registration or notification of a medical device is received only through the Rwanda FDA online portal; applications and queries are handled there, and a reference number…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Devices must be labelled in at least one of the official languages used in Rwanda
All medical devices including in vitro diagnostics intended to be marketed in Rwanda must be labelled in at least one of the official languages used in Rwanda; further detailed labelling re…
1 source-linked fact
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
QMS audit is part of registration; mandatory for Class C and D, desk review for abridged, fee included in the registration fee
The QMS audit is part of the medical device registration process. All Class C and Class D devices must apply and pay the relevant QMS audit fees, and the Authority must inspect the manufact…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
RURA type approval of electronic communications equipment
Wireless / radio
RURA approval for importation and supply of electronic communications equipment
Telecom terminal
Radiation protection authorisation or licence, and radiation safety evidence in the device dossier
Radiation
5 maintained overlays
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D14

Fees

Verified
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from the EAC
USD 100
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from SRAs or WHO Listed Authorities
USD 400
4 maintained fee lines · 1 related fact
Checked 2026-09-16
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D15

Review clocks

Verified
Notification procedure · Notification of a medical device under DHT/GDL/024 section 1.10.1
20 days
Abridged assessment procedure · Abridged assessment taking account of WHO prequalification or an SRA or EAC registration
60 days
Full assessment procedure · Full assessment of the complete dossier under DHT/GDL/024 section 1.10.1
180 days
3 maintained pathways · 1 related fact
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
Full registration valid 5 years, notification 3 years, conditional registration up to 3 years, with annual retention
A certificate of full registration is valid for five years from issuance and may thereafter be renewed, subject to payment of prescribed annual retention fees. A certificate of notification…
1 source-linked fact
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Any variation must be notified in writing, with major and minor variations distinguished and separately fee'd
Any variation to a registered medical device or IVD's information must be notified in writing to the Authority through an application in the approved format, as per the variation guidelines…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Device listing identifier in the registration dossier, registration identifiers in the public register, and lifecycle traceability
Three linked devices exist. First, the registration dossier must carry a 'Listing of Device(s)': 'Where applicable, a table listing each variant/model/configuration/component/accessory that…
1 source-linked fact
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Clinical evaluation report, device-specific clinical trials and post-market study plans in the registration dossier
Registration of a medical device in Rwanda requires an overall clinical evidence submission. ToC section 4.02 ('Overall Clinical Evidence Summary') requires a brief one to two page summary…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
Emergency use authorisation during a declared national public health emergency
The Authority may issue an authorisation for emergency use when a national public health emergency has been declared and the device meets one of the listed requirements: it is listed as pre…
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
Manufacturer risk management across the whole lifecycle linked to post-marketing surveillance, with periodic PSM reporting
Rwanda FDA imposes an explicit manufacturer side post market obligation chain. Section 5.5 of the safety and vigilance guideline provides that 'Manufacturers shall manage risks of their pro…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Affirmative duty to report medical-device incidents, field safety corrective actions and trends, with fixed timelines and a prescribed form
Rwanda FDA's safety and vigilance guideline imposes the incident reporting duty affirmatively and in terms: 'In addition, anybody can report incidents; however, healthcare professionals and…
1 source-linked fact
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
Mandatory FSN/FSCA reporting, regulatory withdrawal, and classified recall timelines with post-recall notification
Rwanda FDA treats field safety corrective action and recall as reportable and enforceable post market events. The safety and vigilance guideline requires that 'Field Safety Notices (FSN) an…
1 source-linked fact
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Prior authorisation for promotion and advertising of medical devices, with claim content rules and claim substantiation
Rwanda FDA's promotion regulations apply to medical devices by definition: 'Regulated product' means processed foods, pharmaceutical products, vaccines, human and veterinary processed foods…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Statutory appeal and review rights against registration decisions, with the deficiency and refusal communications that precede them
Rwanda gives an express, timed appeal against a decision of the Authority. Article 37 of the registration regulations provides: 'Any person aggrieved by a decision of the Authority may appe…
1 source-linked fact
Checked 2026-09-16
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Government fees

Full fee schedule (4 lines) →

Rwanda FDA registration fees in USD · reviewed 2026-09-16

Fee lineAmountProvenance
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from the EACUSD 100Verified
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from SRAs or WHO Listed AuthoritiesUSD 400Verified
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from other sourcesUSD 600Verified
Notification of the registration of machinery, medical equipment and devicesUSD 0Verified

Registration timeline

Full registration timeline →

Rwanda Food and Drugs Authority (Rwanda FDA) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
Notification procedure(Notification of a medical device under DHT/GDL/024 section 1.10.1)20 days20-40 daysVerified
Abridged assessment procedure(Abridged assessment taking account of WHO prequalification or an SRA or EAC registration)60 days60-90 daysVerified
Full assessment procedure(Full assessment of the complete dossier under DHT/GDL/024 section 1.10.1)180 days180-240 daysVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(20 days)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 4 Rwanda regulations →

Official Rwanda FDA rules and guidance · 4 of 4 documents linked to official sources

DHT/GDL/024 Version 2Guidelines for Registration of Medical Devices (DHT/GDL/024 Version 2)
RegistrationVerified
ODG/RAHC/GDL/001 Rev_.3Guidelines on Reliance for Regulatory Decision-Making (ODG/RAHC/GDL/001 Rev_.3)
GeneralVerified
ODDG/RES/TRG/001 Version 5Regulations Governing Tariffs/Fees for Services Rendered by Rwanda Food and Drugs Authority (ODDG/RES/TRG/001 Version 5)
GeneralVerified
DFAR/HMDAR/TRG/002 Rev_2Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics (DFAR/HMDAR/TRG/002 Rev_2)
RegistrationVerified
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