 
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002 Rev_2     
  
 
 
 
 
 
 
 
 
 
 
 
 
 
REGULATIONS GOVERNING THE REGISTRATION OF 
MEDICAL DEVICES INCLUDING IN VITRO DIAGNOSTICS  
 (Rwanda FDA  law no 003/2018 of 09/02/2018, article 9)  
 
 
 Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 2 of 15 
 
Regulation development history  
 
Draft zero  14th August 2019  
Adoption by Rwanda FDA  06th February 2020  
Stakeholders consultation  18th  February 2020 and on 27th  
May 2022  
Adoption of stakeholders’ comments  25th  February 2020 and on 14th 
June 2022  
Date for coming into effect  20th April 2020  
 
Document revision history  
 
Date of revision  Revisio n number  Changes made and/or reasons for revision  
20/04/2020  0 First Issue  
08/06/2021  1 1. The article on reliance is included . 
2. The article on authorization for emergency 
use is included . 
3. The article on donation of medical 
products included . 
interline is ch anged from 1.5 to 1.15 as per sop 
on internal document control.  
22/08/2022  2 1. In this version, in vitro diagnostics devices 
were added as products regulated under 
this regulation.  
2. Notification application was added in the 
following articles 6, 7, 13, 19, 2 2, 26, 28.  
3. The article 8, 15 were revised . 
4. This regulation will now regulate both 
human and veterinary medical devices 
including in vitro diagnostic device.  
5. Editorial Changes  
 
   
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 3 of 15 
 
Adoption and Approval of the Regulations  
  
 
 
 
 
 
 
 
 
 
 
 
 
   
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 4 of 15 
 
Arrangement of the Regulations  
 
REGULATION DEVELOPME NT HISTORY  ................................ ................................ ...................  2 
DOCUMENT REVISION HIS TORY  ................................ ................................ ................................ .........  2 
ADOPTION AND APPROVA L OF THE REGULATIONS  ................................ .............................  3 
CHAPTER ONE: GENERAL  PROVISIONS ................................ ................................ .....................  6 
ARTICLE ONE: PURPOSE OF THESE REGULATIONS  ................................ ................................ .............  6 
ARTICLE 2: CITATION  ................................ ................................ ................................ ........................  6 
ARTICLE 3: APPLICATION  ................................ ................................ ................................ ..................  6 
ARTICLE 4: DEFINITIONS  ................................ ................................ ................................ ...................  6 
CHAPTER II: REGISTRA TION OF MEDICAL DEVI CES AND IN VITRO DIA GNOSTICS 
DEVICES  ................................ ................................ ................................ ................................ ............  8 
ARTICLE 5: CLASSIFICATION OF MEDICAL DEVICES AND IN VITRO DIAGNOSTICS DEVICES  .............  8 
ARTICLE 6: APPLICATION AND REQUI REMENTS FOR REGISTRATION OF MEDICAL DEVICES AND IN 
VITRO DIAGNOSTIC DEV ICES ................................ ................................ ................................ ..............  8 
ARTICLE 7: TECHNICAL REQUIREMENT S ................................ ................................ ............................  8 
ARTICLE 8: LANGUAGE FOR APPLICATION  ................................ ................................ .........................  9 
ARTICLE 9: AUTHENTICITY OF DOCUM ENTS  ................................ ................................ ......................  9 
ARTICLE 10: SAFE CUSTODY AND CONF IDENTIALITY OF INFOR MATION  ................................ .............  9 
ARTICLE 11: ASSESSMENT PROCESS OF  MEDICAL DEVICES AND IN VITRO DIAGNOSTICS  .................  9 
ARTICLE 12: QUALITY MANAGEMENT SYSTEM AUDIT FOR MEDI CAL DEVICES INCL UDING IN VITRO 
DIAGNOSTICS REQUIREME NTS ................................ ................................ ................................ .........  10 
ARTICLE 13: CERTIFICATE OF REGIST RATION OR NOTIFICATI ON OF MEDICAL DEVICES INCLUDING IN 
VITRO DIAGNOSTICS  ................................ ................................ ................................ .......................  10 
ARTICLE 14: CONDITIONAL REGISTRAT ION (TO BE DEFINED ) OF MEDICAL DEVICES AND IN VITRO 
DIAGNOSTICS  ................................ ................................ ................................ ................................ ... 10 
ARTICLE 15: AUTHORIZATION FOR EME RGENCY USE ................................ ................................ ....... 10 
ARTICLE 16: RELIANCE  ................................ ................................ ................................ ...................  10 
ARTICLE 17: APPROVAL OF MEDICAL DEVICES INCLUDING IN VITRO DIAGNOSTICS  ......................  11 
ARTICLE 18: PUBLICATION OF A REGI STERED MEDICAL DEVICE INCLUDING IN VITRO DIAGNOSTIC
 ................................ ................................ ................................ ................................ ........................  11 
ARTICLE 19: VALIDITY OF REGISTRAT ION OR NOTIFICATION  ................................ ...........................  11 
ARTICLE 20: APPLICANT ’S OBLIGATIONS  ................................ ................................ ........................  11 
ARTICLE 21: APPLICATION FOR VARIA TION OF A REGISTERED  MEDICAL DEVICE INCL UDING IN VITRO 
DIAGNOSTIC  ................................ ................................ ................................ ................................ ..... 11 
ARTICLE 22: RETENTION OF MEDICAL DEVICES INCLUDING IN VITRO DIAGNOSTICS ON THE 
REGISTER  ................................ ................................ ................................ ................................ .........  12 
ARTICLE 23: APPLICATION FOR RENEW AL OF THE CERTIFICAT E OF REGISTRATION  OR NOTIFICATION
 ................................ ................................ ................................ ................................ ........................  12 
ARTICLE 24: SUSPENSION OF A REGIS TERED MEDICAL DEVICE INCLUDING IN VITRO DIAGNOSTIC  12 
ARTICLE 25: NOTICE OF S USPENSION OF A REGIS TERED MEDICAL DEVICE INCLUDING IN VITRO 
DIAGNOSTIC  ................................ ................................ ................................ ................................ .... 12 
ARTICLE 26: CANCELLATION OR REVOC ATION OF A CERTIFICA TE OF REGISTRATION O R NOTIFICATION
 ................................ ................................ ................................ ................................ ........................  13 
ARTICLE 27: SUSPENSION OR CANCELL ATION OF THE CERTIFI CATE OF REGISTRATION  OR 
NOTIFICATION WITHOUT  NOTICE  ................................ ................................ ................................ ...... 13 
ARTICLE 28: VOLUNTARY CANCELLATIO N OF THE CERTIFIC ATE OF REGISTRATION OR NOTIFICATION
 ................................ ................................ ................................ ................................ ........................  13 
ARTICLE 29: RESTORATION OF A CANC ELLED OR SUSPENDED C ERTIFICATE OF REGIST RATION OR 
NOTIFICATION  ................................ ................................ ................................ ................................ .. 13 
ARTICLE 30: REFUSAL TO ISSUE A CE RTIFICATE OF REGISTR ATION OR NOTIFICATIO N .....................  13  
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 5 of 15 
 
ARTICLE 31: LABEL AND LABELLING O F MEDICAL DEVICES OR IN VITRO DIAGNOSTICS  ................  14 
ARTICLE 32: USAGE OF A MEDICAL DE VICE ................................ ................................ .....................  14 
ARTICLE 33: DONATION OF MEDICAL DEVICES OR IN VITRO DIAGNOSTICS  ................................ ... 14 
CHAPTER III: RESTRIC TION FOR SALE OF UNR EGISTERED MEDICAL DE VICES 
INCLUDING IN VITRO D IAGNOSTIC  ................................ ................................ .........................  14 
ARTICLE 34: PROHIBITIONS  ................................ ................................ ................................ .............  14 
ARTICLE 35: EXEMPTIONS FROM REGIS TRATION  ................................ ................................ .............  14 
CHAPTER IV: MISCELLA NEOUS PROVISIONS  ................................ ................................ ........  15 
ARTICLE 36: ADVISORY OR SCIENTIFI C CO MMITTEE  ................................ ................................ ........  15 
ARTICLE 37: APPEALS  ................................ ................................ ................................ .....................  15 
ARTICLE 38: REGULATORY TOOLS  ................................ ................................ ................................ .. 15 
ARTICLE 39:  ADMINISTRATIVE FAULTS  AND SANCTIONS  ................................ ................................  15 
ARTICLE 40: COMMENCEMENT AND REPE ALING  ................................ ................................ .............  15 
 
   
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 6 of 15 
 
CHAPTER ONE : GENERAL PROVISIONS  
Article One : Purpose of these R egulations  
The purpose of these regulations is to enforce the legal framework to ensure effective and efficient 
registration of human and veterinary Medical Devices including In Vitro Diagnostics , and to 
provide an open, transparent and non -discriminatory p rocess for the registration of Medical 
Devices including In Vitro Diagnostics . 
Article 2 : Citation  
These regulations may be cited as Rwanda FDA  regulations governing the registration of Medical 
Devices  including In Vitro Diagnostics.  
Article 3 : Applicatio n  
These regulations apply to all regulated human and veterinary medical devices including in vitro 
diagnostics dossiers submitted to the Authority for the purpose of marketing authorization.   
Article 4 : Definitions  
in these regulations, unless the contex t otherwise requires:  
1. “Applicant ” means a person who applies for registration of a product to Rwanda FDA, who 
must be the owner of the product. He may be a manufacturer or a person to whose order and 
specifications, the product is manufactured. After the p roduct is registered, the applicant shall 
be the “Marketing Authorisation Holder”. ”. 
2. “Authority ” means Rwanda  Food and Drugs Authority or its acronym “ Rwanda FDA ”, 
established under law no. 003/2018 of 09/02/2018;  
3. “Certificate of Notification ” means a cert ificate issued by the Authority after its approval to 
be marketed; applicable to some devices falling under class a, depending on their extremely 
low risk - to the user or health care providers. ;  
4. “Certificate of Registration ” means a certificate issued by the Authority after its approval to 
market and sell a product in the country;  
5. “Conditional Registration ” the approval of a m edical device including IVD that addresses 
unmet medical needs of patients on the basis of less comprehensiv e data than normally 
required. T he available data  must indicate that the medical device or IVD ’s benefits outweigh 
its risks and the applicant should be in a position to provide the comprehensive clinical data 
in the future.   
6. “Documentation” a compilation of requir ed information for registration including  samples 
and any other  additional information requested for registration .  
7. “Fee” means the fee prescribed in regulation CBD/TRG/ 004 related to regulatory service 
tariffs/fees and fines;  
8.  “Implantable device” means any device which  is intended: - to be totally introduced into the 
human or animal bodies or, to replace an epithelial surface or the surface of the eye, by surgical 
intervention which is intended to remain in place after the procedure. any device intended to be 
partially introduced into the human body through surgical intervention and intended to remain in 
place after the procedure for at least 30 days is also considered an implantable device.  
9. “Invasive device” a device, which, in whole or in part, penetrates inside the b ody, either 
through a body orifice or through the surface of the body. body orifice means any natural  
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 7 of 15 
 
opening in the body, as well as the external surface of the eyeball, or any permanent artificial 
opening, such as a stoma or permanent tracheotomy.  
10. “In Vi tro Diagnostic Device ” means a medical  device, whether used alone or in combination, 
intended by the manufacturer for the in vitro examination of specimens derived from the 
human or animal body solely or principally to provide information for diagnostic, m onitoring 
or compatibility purposes. this includes reagents, calibrators, control materials, specimen 
receptacles, software, and related instruments or apparatus or other articles; IVD medical 
devices  include reagents, calibrators, control materials, speci men receptacles, software, and 
related instruments or apparatus or other articles and are used, for example, for the following 
test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, 
prediction, determination of physio logical status;  
11. “Label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed 
stencilled , marked, embossed or impressed on or attached to a container of any medical device 
or medical devices and in vitro diagnostics devices;  
12. "Labelling " is all labels and other written, printed, or graphic matter (l) upon any article or 
any of its containers or wrappers, or (2) accompanying such article" at any time while a device 
is held for sale after shipment or delivery for shipment in inter state commerce.  
13. “Law” means law no. 003/2018 of 09/02/2018 establishing the Rwanda FDA  and determining 
its mission, organization and functioning.  
14. “Local Technical Representative (LTR )” means any corporate body registered in Rwanda  
and authorized by the Rwanda FDA  to deal with medical devices and in vitro diagnostics that 
has received a mandate from the applicant to act on his/her behalf with regard to matters 
pertaining to the registration of medical devices including IVD s. 
15. “Manufacture ” means all operation s that involve preparation, processing, filling 
transforming, packaging, repackaging and labelling of medical devices and in vitro diagnostic 
devices;  
16. “Manufacturer ” means a person or a firm that is engaged in the manufacture of medical 
devices and in vitr o diagnostic devices;  
17. “Medical device family” means a group of medical devices that are made by the same 
manufacturer, that differ only in shape, colour, flavour or size, that have the same design and 
manufacturing process and that have the same intended u se;  
18. “Medical device group family” means a collection of medical device groups that are made 
by the same manufacturer, that have the same generic name specifying their intended use and 
that differ only in the number and combination of products that compris e each group.  
19. “Medical device group” means a group of devices comprising a collection of medical 
devices, such as a procedure pack or tray, that is sold under a single name.  
20. “Medical device”   means any instrument, apparatus, implement, machine, appliance,  implant, 
software, material or other similar or related article, intended by the manufacturer to be used, 
alone or in combination, for human beings or animals, for one or more of the specific medical 
purpose(s) of diagnosis, prevention, monitoring, treatm ent or alleviation of disease; diagnosis, 
monitoring, treatment, alleviation of or compensation for an injury; investigation, 
replacement, modification or support of the anatomy or a physiological process; supporting or 
sustaining life; control of concepti on; disinfection of medical devices; providing information 
by means of in vitro examination of specimens derived from the human or animal bodies, and 
which does not achieve its primary intended action by pharmacological, immunological or  
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 8 of 15 
 
metabolic means, i n or on the human or animal body, but which may be assisted in its intended 
function by such means.  
21. “Medical device system”: a medical device comprising a number of components or parts 
intende d to be used together to fulfil  some or the entire device’s inte nded functions and that is 
sold under a single name.  
 
CHAPTER II: REGISTRATION OF MEDICAL DEVICES AND IN VITRO 
DIAGNOSTICS DEVICES  
Article 5 : Classification o f Medical Devices a nd In Vitro Diagnostics Devices  
There shall be four (4) classes of medical dev ices and in vitro diagnostics , as provided in the rules 
set out in the schedule of these regulations depending on their levels of risk as follows:  
a. Low risk class  
b. Low to moderate risk class  
c. Moderate to high risk class  
d. High risk class.  
Where a medical devi ce including in vitro diagnostics falls into more than one class, the class 
representing the higher class shall apply. The Authority shall have a final decision on the 
classification of a medical device and in vitro diagnostics based on different factors s uch as the 
intended use, device risk, and regional endemics, among others.  
Article 6 : Application and requirements for registration of medical devices and in vitro 
diagnostic devices  
All medical devices including in vitro diagnostics shall be registered or  given a notification (where 
applicable) by the Authority before they are pla ced on the Rwanda n market.  Aperson who intends 
to manufacture, import or export a single medical device, in vitro diagnostic, a medical device 
group, medical device family, medica l device group family or a medical device system  shall  apply 
to the  Authority for registration or notification.  
 
An application for registration or notification of medical devices including in vitro diagnostics 
shall be made to the Authority in writing by  the applicant, the manufacturer or a local technical 
representative.  
 
Application for registration or notification of medical devices including in vitro diagnostics shall 
be made in el ectronic copies as detailed in Rwanda FDA  guidelines for submission of  
documentation for registration of medical devices or guidelines on submission of documentation 
for registration of in vitro diagnostic devices.   
 
Every application shall be accompanied by the following:  
a. Proof of payment of non -refundable registration fe e; and  
b. sample or samples of the device, where applicable and, or artwork.  
Article 7 : Technical requirements  
All applications for registration or notification of medical devices including in vitro diagnostics 
shall comply with the technical requirements d emonstrating quality, safety and performa nce as  
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 9 of 15 
 
determined by Rwanda FDA  Guidelines on submission of documentation for registration or 
notification of medical devices and guidelines on submission of documentation for registration of 
in vitro diagnostic dev ices. 
Article 8 : Language for application    
All applications and supporting documents shall be submitted in English , French or 
Kinyarwanda  language . Where some documents are subm itted in a language other than English, 
French or K inyarwanda , the applicant shall submit translated copies to expedite the review 
process.  
Article 9 : Authenticity of documents  
Any document submitted to the Authority must be authentic.  The Authority shall reject an 
application for registration or notification of a medical device o r in vitro diagnostic if it is satisfied 
that the submitted documents are not authentic or the integrity of data is questionable. Any 
applicant is responsible for the authenticity of the contents of his/her application.   
Article 10 : Safe custody and confi dentiality of information  
The Authority shall ensure safe custody of information related to the registration or notification 
of medical devices or in vitro diagnostic devices submitted by an applicant.  
 
All information submitted by an applicant shall be tr eated confidential ly and shall not be disclosed 
to any third party without a prior written consent of the applicant or his/her representative.  
Article 11 : Assessment process of Medical Devices and In Vitro Diagnostics  
The Authority shall, upon being  satisfied by the completeness of the application, conduct 
assessment to verify the compliance with safety, quality and performance requirements through 
full or abridged assessment procedures. The Authority shall set out guidelines, sops (to recheck), 
forms, and  tools for full and abridged assessment procedures.  
 
The authority may, during the assessment of the device, request the applicant to submit additional 
samples, documents, information, data or clarification to support the application for registration.  
 
Where the Authority requires the information stated above, the processing of the application shall 
not proceed untilthe applica nt provides the required additional  information . 
 
Where the applicant fails to submit the requested information, within the period o f ninety (90) 
days from the date of request, the application shall be considered withdrawn.  
 
The applicant may by giving reasons in writing request for an extension of time for submission of 
additional samples, documents, information, data and or clarifica tion requested by the Authority.  
 
If the applicant fails to provide satisfactory responses to the requested informationfor a fourth 
time, the application shall be rejected.  
  
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 10 of 15 
 
An application withdrawn or rejectedshall only be considered for registration upon  submission of 
a new application as per the requirements of these regulations.  
Article 12 : Quality Management System audit for medical devices including In Vitro 
Diagnostics requirements  
During the assessment of medical devices and in vitro diagnostics, th e Authority shall, as it may 
deem necessary, conduct quality management system audits of manufacturers, and production site 
to confirm the authenticity, precision and integrity of information and data submitted.  
Article 13 : Certificate of registration or notification of Medical Devices including In Vitro 
Diagnostics  
The Authority shall issue a certificate of registration or a certificate of notification to medical 
devices or in vitro diagnostics only if:  
a. The medical device or in vitro diagnostic dossier is  assessed and fulfil s all the requirements 
of safety, quality and performance,  
b. The manufacturing site of the medical device or in vitro diagnostic is compliant with 
Quality Management System requirements,  
c. Medical devices or in vitro diagnostics fulfil the requirements of laboratory quality tests.  
Article 14 : Conditional registration (to be defined) of medical devices and in vitro 
diagnostics  
The Authority shall specify the conditions which need to be fulfilled by the applicant to acquire 
conditional regi stration prior to issuance of full registration certificate.  
Article 15 : Authorization for emergency use  
The Authority may issue the authorization for emergency use when a national public health  
emergency has been declared and the device fulfils one of t he following requirements:  
a. Listed as prequalified or granted authorization for emergency use by the W orld Health 
Organization ( WHO ) or world org anisation for animal health (OIE ), 
b. Registered or granted auth orization for emergency use by Stringent R egulatory  Authorities,  
c. Registered or granted authorization for emergency use by countries having  
d. Collaborative agreements with the Authority, and  
e. The normal device registration process is ongoing and the Authority decides to grant  
f. Authorization for emergency use ba sed on the severity of the declared public health  
emergency.  
The Authority may issue the authorization for emergency use when a national public health 
emergency has been declared by the Ministry of Health.  
The Authority may permit the emergency use of an u nregistered medicinal product or may permit an 
unapproved use of a registered medicinal product.  
Furthermore, a medicinal product may or may not have undergone human efficacy trials, due to risk, 
feasibility or ethical considerations.  
Article 16 : Reliance  
The A uthority may rely on regulatory decisions from regional, international and other stringent 
regulatory authorities’ decisions regarding  product market authorization when deemed necessary.   
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 11 of 15 
 
Article 17 : Approval of Medical Devices including In Vitro Dia gnostics  
Upon approval of registration of medical devices or in vitro diagnostics, the Authority shall:  
a. Enter in the register the prescribed particulars of the medical device or in vitro diagnostic;  
b. Allocate a registration number to the medical device or i n vitro diagnostic device ; 
c. Issue to the applicant a certificate of full, conditional or emergency registration or a 
certificate of notification as per the prescribed format.  
Article 18 : Publication of a registered Medical Device including In Vitro Diagnost ic 
The Authority shall publish a list of registered medical devices or in vitro diagnostics on the 
authority’s website including but not limited to the following:  
a. The brand name, generic name, and model, where applicable of the devices;  
b. The registration nu mber allocated to the device on registration;  
c. The intended purpose or use of the device;  
d. The name and the country of the marketing authorization holder of the certificate 
registration or the certificate of notification;  
e. The name and country of the origin al manufacturer;  
f. The date of registration of the device and registration status;  
g. The class of the device; and  
h. The device nomenclatur e code allocated to the device;  
i. Local technical representative;  
j. Expiry date of the registration certificate or the certifi cate of notification.  
Article 19 : Validity of registration or notification  
A certificate of full registration issued under article 13 shall, unless earlier suspended or revoked, 
and subject to payment of prescribed annual retention fees, be valid for a per iod of five (5) years 
from the date of issuance and may thereafter be renewed. The certificate of notification , however, 
will be valid for a period of 3 years.  
A certificate of conditional registration shall be valid for a period specified in the certific ate and 
that period shall not exceed three (3) years.  
Article 20 : Applicant’s  obligations  
The applica nt shall ensure  and keep objective evidence to establish  that the medical device meets 
all safet y and performance requirements .  
Article 21 : Application f or variation of a registered medical device including in vitro 
diagnostic  
Any variation to a registered  medical device or in vitro diagnostic information shall be notified in 
writing to the Authority through an application in the approved format.  
 
An appl ication for variation shall be submitted as per the requirements set out in the relevant 
guidelines for variation of registered medical devices including in vitro diagnostics in force at the 
time of submission.  
  
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 12 of 15 
 
A distinction shall be made between major a nd minor variations in accordance with the relevant 
guidelines for variation of registered medical devices including in vitro diagnostics and there shall 
be a distinction in the payment of applicable fees.  
Article 22 : Retention of Medical Devices includin g In Vitro Diagnostics on the register  
The registered medical device or in vitro diagnostic is retained on the register annually after 
fulfilling the requirements including payment of prescribed fees.  
An application for retention on the register shall be submitted one (1) month before the due date.  
The medical device or in vitro diagnostic shall be removed from the register if the application and 
payment of prescribed fees are not effected .   
Article 2 3: Application for renewal of the certificate of regis tration or notification  
Application for renewal of registration or notification shall be made to the Authority at least ninety 
(90) calendar days before its expiry.  
A grace period for renewal shall extend to ninety (90) days after the specified expiry date . 
Failure to renew the certificate of registration or notification within the grace period, the 
application shall be considered as new.  
The application shall be in the prescribed format as per Rwanda FDA  guidance for renewal of 
registration of medical dev ices including in vitro diagnostics.  
Article 2 4: Suspension of a registered Medical Device including In Vitro Diagnostic  
The Authority may suspend registered devices if it is satisfied that:  
A registered device has been advertised in a manner which is fa lse or misleading or does not 
comply with the provisions of the laws and regulations currently enforced by the Authority;  
The marketing authorization holder has contravened these regulations or any other provision of 
the laws;  
The marketing authorization h older made a false or misleading statement or misrepresentation in 
the application;  
The marketing authorization holder has failed to comply with the terms and conditions of the 
registration as provided for in the certificate of registration or notification ; 
The marketing authorization holder has failed to pay the prescribed retention fees within the 
prescribed time;  
The marketing authorization holder has failed to submit periodic post -marketing surveillance 
reports;  
The marketingauthorization holder, intent ionally and without justifiable reasons has failed to 
submit reports on adverse effects , and the renewal of registration has defaulted beyond the 
specified grace period.  
Article 2 5: Notice of suspension of a registered Medical Device including In Vitro Di agnostic  
Any suspension shall be effected upon a written notice thereof. the notice for suspension of 
registered devices shall:  
Set out the reason for the proposed suspension, any corrective action required to be taken and the 
time within which it must be  taken;  
Require the marketing authorization holder to show reasons in writing along with evidence (if 
any) as to why the suspension should not be effected.   
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 13 of 15 
 
Article 2 6: Cancellation or revocation of a certificate of registration or notification  
The Author ity may cancel or revoke  the marketing authorization of a registered medical device or 
in vitro diagnostic if:  
a. It is not in the public interest that the registered device should be made or continue to be 
made available;  
b. The device has been banned in Rwanda ; 
c. The device no longer meets the quality, safety and performance requirements; and  
d. The marketing authorization has been suspended for a period of more than 12 months.  
 
Under  the provision of article 25 (a),  a written notice of cancellation or revocation shall then be 
issued to the marketing authorization holder, stating the reasons for cancellation or revocation.  
Article 2 7: Suspension or cancellation of the certificate of registration or notification without 
notice  
The Authority may if deemed necessary suspend or cancel the certificate of registration or 
notification of a medical device or in vitro diagnostic without prior notice in case the medical 
device or in vitro diagnostic does not meet the safety, quality and performance.  
 
The marketing authorizat ion holder may apply to the Authority, in writing, requesting that the 
cancelation or suspension be uplifted. The Authority may, within thirty (30) days after the date of 
receiving the application review its decision.  
Article 2 8: Voluntary cancellation of  the certificate of registration or notification  
The Authority may , upon request of the applicant  of a medical device or in vitro diagnostic, cancel 
the certificate of registration or notification.  
Article 2 9: Restoration of a cancelled or suspended certi ficate of registration or notification  
Pursuant to the provision of articles 21, 22 and 23, the Authority may, upon satisfaction that the 
reasons of the suspension or cancellation of a registered device have been corrected or if such 
reason s for suspensio n or cance llation were unfounded, restore the certificate of registration or 
notification.  
Article 30 : Refusal to issue a certificate of registration or notification  
The A uthority may refuse to issue or amend a certificate of registration or notification  if: 
a. The applicant does not comply with these regulations or any provisions of the law relating 
to medical devices or in vitro diagnostics;  
b. The applicant has made a false or misleading statement in the application;  
c. The medical device or in vitro diagnost ic does not comply with the labelling requirements 
set out in these regulations; and  
d. The applicant has not complied with a request for additional information or samples by the 
day specified in the request.  
e. The device does not meet the quality, safety and performance requirements, or if the 
information or samples provided with the application are insufficient to enable the 
Authority to determine if the device meets these requirements.   
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 14 of 15 
 
Where the Authority refuses to issue or amend a certificate of registrat ion or notification, the 
Authority shall:  
a. Notify the applicant in writing of the reasons for the refusal; and  
b. Allow the applicant  to show reasons in writing along with evidence, if any, on the decision 
of the Authority .  
Article 31 : Label and labelling of Medical Devices or In Vitro Diagnostics  
All Medical Devices including In Vitro Diagnostics intended to be marketed in Rwanda  shall be 
label led in at least one of the official languages used in Rwanda . other detailed information for 
label ling will be determ ined by relevant guidelines.  
Article 32 : Usage of a medical device  
A medical device shall not, when used for the medical conditions, purposes or uses for which it is 
manufactured, sold or represented, adversely affect the health or safety of a pat ient, us er or another 
person.  
A medical device shall be used as intended by the manufacturer and shall be effective for the medical 
conditions and purposes for which it is manuf actured, sold or represented.  
During the projected useful life of a medical device, i ts characteristics and performance shall not 
deteriorate under normal use to such a degree that the health or safety of a patient, user or other 
person is adve rsely affected.  
The characteristics and performance of medical devices shall not be adversely aff ected by transport 
or conditions of storage, taking into account the manufacturer’s instructions and information for 
transport and storage.  
Article 33 : Donation of Medical Devices or In Vitro Diagnostics  
Medical Devices and In Vitro Diagnostics to be dona ted shall comply with the established relevant 
guidelines.  
 
CHAPTER III: RESTRICTION FOR SALE OF UNREGISTERED  MEDICAL DEVICES 
INCLUDING  IN VITRO DIAGNOSTIC  
Article 34 : Prohibitions  
No person shall manufacture,  prepare , store,  export,  sell, dispense, distr ibute or import Medical 
Devices or In Vitro Diagnostics Devices unless the person must hold the appropriate certificate of 
registration or notification issued by the Authority.  
 
No person shall manufacture,  prepare , store,  export,  sell, dispense, distribut e or import an 
adulterated; counterfeit; or generally harmful medical device. Medical devices should be  in 
accordance with the provisions of these regulations .  
Article 35 : Exemptions from registration  
Notwithstanding the provision of article 29, these re gulations shall not apply to devices intended 
to be used in research and development studies, without prejudice to the provisions of the 
regulations on clinical trials in force.  
  
  
Regulations Governing Registration o f Medical Devices including In Vitro 
Diagnostics  
 
 
Doc Ref No.: DFAR/HMDAR/TRG/002  Rev_2   Page 15 of 15 
 
CHAPTER IV: MISCELL ANE OUS PROVISIONS  
Article 3 6: Advisory or scientific comm ittee  
The Authority shall appoint an advisory or scientific committee, including external experts, to 
assist the Authority in making decisions, particularly in cases when greater knowledge is required 
or when a public health emergency occurs.  
Article 3 7: Appeals  
Any person aggrieved by a decision of the Authority may appeal to the Authority for review of 
the decision showing grounds for dissatisfaction within thirty (30) calendar days from the date of 
notice.  
 
The Authority shall, within forty -five (45) c alendar days from the date of receiving the application, 
review, reject or uphold its own decision according to applicable laws, and regulations.    
 
The applicant shall not be barred from appealing to the minister/ board of directors without 
applying to t he Authority for review. If a person is dissatisfied with the decision after review, 
he/she may appeal to the supervising Authority whose decision shall be final.  
Article 38 : Regulatory tools  
The A uthority shall issue guidelines, SOP s, and forms necessar y for the implementation of these 
regulations   
Article 39 : Administrative faults and sanctions  
A person who manufacture s, sells, distributes, import s or export s an unapproved Medical Device 
including In Vitro Diagnostic  commits an administrative fault. He /She shall be liable for 
administrative fines equivalent to double the value of condemned products plus tests related costs, 
when testing is compulsory.  
Article 40 : Commencement and repealing  
This regulation shall enter into force on the date of its signa ture and publication. All prior contrary 
provisions to these regulations are hereby repealed.  
 
 
End of document  