Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
Doc. Ref.No.: FDISM/FDIEC/TRG/003  Rev_0  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REGULATIONS GOVERNING CONTROL OF IMPORTATION 
AND EXPORTATION OF FOOD PRODUCTS  
(Rwanda FDA Law No. 003/2018 of 09/02/2018, Article 9)  
 
 
 
 
 
 
 
 
 
  
 Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
Doc. Ref.No.: FDISM/FDIEC/TRG/003, Rev_0                                                            Page 2 of 14 
REGULATION DEVELOPMENT HISTORY  
 
DRAFT ZERO  12/08/2022  
ADOPTION BY RWANDA FDA  21/10/2022  
STAKEHOLDERS CONSULTATION  10/11/2022  
ADOPTION OF STAKEHOLDERS’ COMMENTS  17/11/2022  
DATE FOR COMING INTO EFFECT  16/12/2022  
 
DOCUMENT REVISION HISTORY  
 
Date of revision  Revision number  Changes made and/or reasons for  
Revision  
24/11/2022  0 First issue  
 
   Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
Doc. Ref.No.: FDISM/FDIEC/TRG/003, Rev_0                                                            Page 3 of 14 
ADOPTION AND APPROVAL OF THE REGULATIONS  
 
  
 
  
 Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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TABLE OF CONTENT  
 
REGULATION DEVELOPMENT HISTORY  ................................ ................................ ...................  2 
DOCUMENT REVISION HISTORY  ................................ ................................ ................................ . 2 
ADOPTION AND APPROVAL OF THE REGULATIONS  ................................ .............................  3 
TABLE OF CONTENT  ................................ ................................ ................................ .......................  4 
CHAPTER I: GENERAL PROVISIONS  ................................ ................................ ...........................  6 
Article one: Purpose of these Regulations  ................................ ................................ ...........................  6 
Article 2: Citation  ................................ ................................ ................................ ................................  6 
Article 3:  Application  ................................ ................................ ................................ ..........................  6 
Article 4: Definitions  ................................ ................................ ................................ ...........................  6 
CHAPTER II: IMPORTATION / EXPORTATION OF FOOD PRODUCTS  ................................ ... 7 
Article 5: Obligation to obtain an  Import Visa  ................................ ................................ ....................  7 
Article 7: Special cases  ................................ ................................ ................................ ........................  8 
Article 8: Quality and safety Requirements for importation of food products  ................................ .... 8 
Article 9: M anagement of deviations  ................................ ................................ ................................ .. 8 
Article 10: Importation of registered and listed food products  ................................ ............................  8 
Article 11:  Eligibility to import/export food products  ................................ ................................ ........  9 
Article 12: Physical inspection of food products  ................................ ................................ .................  9 
Article 13: Gazetted/approved ports of entry and exit  ................................ ................................ ....... 10 
CHAPTER III: VALIDITY, REFUSAL AND SUSPENSION OR WIT HDRAWAL OF AN 
IMPORT/EXPORT AUTHORIZATION  ................................ ................................ ..........................  10 
Article 14: Validity of an Authorization  ................................ ................................ ............................  10 
Article 15: Suspension or withdrawal of an authorization  ................................ ................................  10 
CHAPTER IV: RENEWAL AND VARIATION OF AN AUTHORIZATION  ...............................  11 
Article 16 Renewal of an import license  ................................ ................................ ...........................  11 
Article 17: Variation of an authorization  ................................ ................................ ...........................  11 
CHAPTER V: MISCELLANEOUS PROVISIONS  ................................ ................................ .........  11 
Article 18: Establishment of Advisory Committee  ................................ ................................ ...........  11 
Article 19: Compliance with other requirements  ................................ ................................ ...............  11 
Article 20: Administrative sanctions  ................................ ................................ ................................ . 11 
Article 21: Appeal and review  ................................ ................................ ................................ ...........  12 
Article 22: Power to issue guidelines  ................................ ................................ ................................  12 
Article 23: Revision of these Regulations  ................................ ................................ .........................  12 
   Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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Article 24: Commencement and repealing  ................................ ................................ ........................  13 
ANNEX A  ................................ ................................ ................................ ................................ .........  14 
 
   Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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CHAPTER I: GENERAL PROVISIONS  
  
Article one : Purpose of these Regulations  
 
The purpose of these Regulations is to provide a legal framework for the effective and efficient control 
of importation and exportation of Food Products  in a transparent, non -discriminatory process of their 
importation and/or exportation.  
 
Article 2 : Citation   
 
These Regulations may be cited as the “Regulations No FDISM/FDIEC/TRG/00 3 Rev_0, Governing 
Control of Importation and Exportation of Food Products.”   
 
Article 3 : Application  
 
These regulations shall apply to the authorization of importation or exportation of Food Products, for 
public, private and non -profit organizations and p ersonal use, as stipulated in Article 3 of Law No 
003/2018 of 09/02/2018 establishing the Rwanda FDA and determining its mission, organization and 
functioning.  
 
Article 4 : Definitions  
 
In these regulations, unless the context otherwise requires:  
 
“Autho rity”  means the Rwanda Food and Drugs Authority or its acronym “Rwanda FDA”, 
established under Article 2 of the Law No 003/2018 of 09/02/2018 and determining its mission, 
organization, and functioning;  
 
“Authorization”  means a legal document granted by Rwa nda Food and Drugs Authority to an 
applicant under the Law No 003/2018 of 09/02/2018 establishing Rwanda FDA and determining its 
mission, organization and functioning; it includes import visa, import/export licence, To Whom or 
other certificates.   
 
“Autho rized person” means  
 
1° any person who holds a licence to manufacture, import, export, distribute, wholesale or retail 
food products issued in terms of Law No. 003/2018 of 09/02/2018 establishing the Rwanda 
FDA and determining its mission, organization and functioning and Law No.  47/2012 of 
14/01/2013 Relating to the regulation and inspection of food and pharmaceutical products; or  
 
2° any person approved as such by the Authority in relation to this regulation.  
 
“Certificate of Analysis ” means an official document that meant to tes tify quality control data for a 
particular lot/batch of product,   Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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“Certificate of Compliance” means a Certificate given by an authorized institution in the exporting 
country confirming that the manufacturer or distributor operate in that country complying w ith 
requirements related to food manufacturing.  
 
“Fee”  means the regulatory service fee charged in correspondence with service issued as prescribed 
in the Tariff of Fees for services rendered by Rwanda FDA Regulations in accordance with Article 9 
and Arti cle 32 of the Law No 003/2018 of 09/02/2018 and determining its mission, organization and 
functioning.  
 
“Food product”  means any animal or plant products that have been processed or transformed from 
their original state and are intended for human or anima l consumption including but not limited to 
beverages, food supplements, tobacco, food additives and food fortificants;  
 
“Manufacturer”  means a person or corporation, or other entity engaged in the business of 
manufacturing Food Products;   
 
“Premises”  means any plot of land, buildings or boats, aircrafts, vehicles, a part of a building, 
channels, yards, a place of storage, annexed to a building, or part of that building, carriage or 
receptacle of any kind, whether open or closed used by food handlers.  
 
In these Regulations, the following verbal forms are used:   
 
“shall”  indicates a requirement;  
 
“should”  indicates a recommendation;  
 
“may”  indicates a permission; and   
 
“can”  indicates a possibility or a capability.  
 
CHAPTER II: IMPORTATION / EXPORTATION OF FOOD PRODUCTS           
 
Article 5 : Obligation to obtain an Import Visa   
 
Any person intending to import any food products shall apply for an Import Visa for each consignment 
prior to applying for import license. The Visa is issued by the A uthority in accordance with these 
Regulations and guidelines for importation and exportation of food products.  
 
All required documentation for application shall be made as described in Guidelines No.:  
FDISM/FDIEC/GDL/002 for importation and exportation of food products.  
   Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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Article 6 : Obligation to obtain an import/export Licence  
 
1° Any person intending to import/export any product shall apply for an import/export license 
issued by the Authority in accordance with these Regulations and guidelines for importati on 
and exportation of food products.  
 
2° All required documentation for application shall be made as described in Guidelines No.: 
FDISM/FDIEC/GDL/002 for importation and exportation of food products.  
 
3° The import license is conditional to physical inspection in order to confirm safety and quality 
of products with regards to related claimed specifications.  
 
4° An authorization to import/export shall not be granted where the Authority finds the applicant 
not complying with the requirements for importation or export ation. The applicant shall be 
informed in writing about the decision and the reasons thereof.  
 
Article 7 : Special cases  
 
In special circumstances including but not limited to products declared as personal effects, emergency 
situations or any other as may be declared by the competent authorities, the article 6 and 7 may not 
be applied. All required documentation for application shall be made as described in relevant 
Guidelines.  
 
Article 8 : Quality and safety Requirements for importation of food products   
 
All food products to be imported shall comply with related quality Standards and requirements 
described in Guidelines No.: FDISM/FDIEC/GDL/002  for importation and exportation of food 
products.  
 
Article 9:  Management of deviations  
 
All National deviations provided by the Standards, shall be considered as mandatory and shall be 
complied with for importation and exportation of food products.  
 
Other deviations from specification limits of tested parameters must be documented and shall be 
approved by the Author ity only if they do not affect the product’s quality and safety.  
 
Article 10 : Importation of registered and listed food products  
 
1° All food to be imported to Rwanda shall be either registered or listed.  
 
2° Products for particular nutritional use, food associa ted with adulteration risk and food with 
stringent regulatory requirements shall be registered with Rwanda FDA prior to importation.  Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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Such food products shall be imported by the Local Technical Representatives or any other 
company authorized by the marketin g authorization holder or by the manufacturer.  
 
3° All low -risk food products shall be listed and imported by any importer who notified the 
Authority  
 
Article 11 :  Eligibility to import/export food products  
 
Applicants eligible to import/export food products include:  
 
1° A manufacturer of food products holding a valid operational license;  
 
2° A wholesaler or retailer of food products holding operational license;  
 
3° Researchers or research institutions authorized by competent institution to conduct 
nutritional researches or clinical trial in the country;  
 
4° An individual or company importing a sample for laboratory testing;  
 
5° Government institutions and non -government institutions;  
 
6° A beneficiary of food products donation;  
 
7° A company or individual attending exhibi tion upon presentation of the invitation;  
 
8° A company or individual attending exhibition;  
 
9° A tourist, a visitor in the country or any other person for justified reasons;  
 
10° Any other reason as the Authority may find it relevant to allow importation or exporta tion 
of food products.  
 
Article 12 : Physical inspection of food products  
 
1° All consignments of food products to be imported or exported shall be subjected to physical 
inspection at port of entry or at importer’s premise for the consignments released under seal, 
before being sold or used to ensure they comply with claimed specifications.  
 
2° The Authority may take samples for quality control testing.  
 
3° If the physical inspection finds out that the consignment doesn’t comply with Food Standards, 
the products shal l be condemned (seized, confiscated, rejected, destroyed…).   
  Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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4° No person shall obstruct or hinder Rwanda FDA inspectors in the exercise of their powers or 
performance of their duties.  
 
5° The Authority, when deemed necessary and for justified reasons, may re lease underseal an 
imported consignment while waiting for the client to comply with importation requirements 
and/or to obtain a full release of the imported products for their intended use.  
 
Article 13 : Gazetted/approved ports of entry and exit  
 
Food prod ucts shall be imported or exported only through Gazetted ports of entry and exit.  
 
CHAPTER III: VALIDITY, REFUSAL AND SUSPENSION OR WITHDRAWAL OF AN 
IMPORT/EXPORT AUTHORIZATION  
  
Article 14 : Validity of an Authorization   
 
1° An import Visa shall be valid for  6 months from the date of its issuance.  
 
2° An import/export License shall be valid for 6 months from the date of its issuance  
 
3° An authorization is issued to an applicant, for a particular consignment, and shall not be 
transferable.   
 
Article 15 : Suspension  or withdrawal of an authorization  
 
An authorization may be suspended or withdrawn where the Authority finds that any of the conditions 
under which authorization was granted for was violated. The conditions include but not limited to the 
following:  
 
1° Cond itions for suspension:  
 
a) Request by the license holder due to impossibility to use the authorization  
 
b) Deceptive or misleading information in the application for authorization  
 
c) A suspicion that the product has effect on the safety of the consumer  
 
2° Conditions for withdrawal:  
 
a) Scientific information that the product is not fit for human consumption  
 
b) Obstruction to physical verification of product by Rwanda FDA inspectors  
 
c) Abandonment of the business by the license holder   Regulations Governing Control of Importation and Exportation of Food 
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The notice of suspension or wi thdrawal shall be issued by the Authority to the applicant.  
 
CHAPTER IV: RENEWAL AND VARIATION OF AN AUTHORIZATION  
 
Article 16  Renewal of an import license  
 
An import license shall be renewed after 6 months from the date it was issued in case it hasn’t been 
used by the applicant after submission of all requirements as specified in Guidelines No 
FDISM/FDIEC/GDL/002 for importation and exportation of food products.  
 
Article 17 : Variation of an authorization  
 
Whenever the Authority varies, amends, or imposes any new condition on the authorization 
requirements, the Authority shall communicate the return of such authorization to be duly endorsed 
within reasonable time.   
 
An application shall be made to the Autho rity for review and approval of any variation made on the 
details of the issued authorization.  
 
CHAPTER V: MISCELLANEOUS PROVISIONS  
 
Article 18 : Establishment of Advisory Committee  
 
1°. The Authority shall establish Import and Export Control Advisory Committe e with clear terms 
of reference;  
 
2°. The committee shall be composed of internal and external multidisciplinary experts with 
specialization in relevant fields to assess all safety and quality issues on importation and 
exportation of food products.  
 
Article 19 : Compliance with other requirements  
 
A company that has been granted with an authorization shall comply with any other requirements as 
may be specified by the Authority.  
 
Article 20 : Administrative sanctions  
 
Any person who contravenes the provisions of  these Regulations, shall be liable to the administrative  
measures and sanctions under Annex A : 
 
1° Importation, sale, storage and distribution of substandard, counterfeit/falsified, expired and 
fraudulent food products;  
 
2° Importation, sale, storage and distri bution of unapproved (unauthorized) food products;   Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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3° Importation/Exportation of unregistered or unauthorized food products without special 
approval given by the Authority  
 
4° Obstruction of inspectors from Rwanda Food and Drugs Authority  
 
5° Failing to dispose o f the rejected consignment within the recommended timeline  
 
6° Failing to re -export consignment that were recommended for re -exportation within the 
recommended timeline  
 
7° Sale, storage and distribution of food products in unauthorized premises  
 
8° Arrival of food  products into the country without import Visa/License or special 
authorization;  
 
In case the consignment complies with safety and documentary requirements for import license on 
the consignment already in Rwanda without visa/license, the importer shall pay  a fine of 5% of the 
value of condemned products before being issued with an import license.  
 
Article 21: Appeal and review  
 
1° Any person aggrieved by a decision of the Authority may apply to the Authority for review of 
the decision showing grounds for dissa tisfaction within thirty ( 30) days from the date of notice.  
 
2° The Authority shall, within thirty ( 30) days from the date of receiving the application, review, 
reject or vary its own decision.  
 
3° If a person is dissatisfied with the decision after review, he m ay appeal to the Minister of the 
supervising Ministry.  
 
Article 22 : Power to issue guidelines   
 
The authority shall issue Guidelines, Standards Operating Procedures, forms and formats necessary 
for the implementation of these Regulations.  
 
Article 23 : Revision of these Regulations  
 
The revision of these regulations shall be done at least after three (3) years from the date of their 
publication, except in case of special circumstances. Amendment shall be communicated to the public 
in due time.  
   Regulations Governing Control of Importation and Exportation of Food 
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Article  24: Commencement and repealing  
 
These regulations come into force on the date of signature and publication by the Authority.  
All Provisions contrary to these regulations are hereby repealed.  
 
End of Document  
 
 
   Regulations Governing Control of Importation and Exportation of Food 
Products  
 
 
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ANNEX A : FAULTS AND ADMINISTRATIVE SANCTIONS  
 
Fault  Administrative sanction  
1. Importation of regulated products without fulfilling 
some of the requirements for the first time 
including certificate of compliance for import visa 
and/or certificate of analysis for import licence.  
 Warning lette r 
2. Importation of regulated products without fulfilling 
some of the requirements for the second time 
including certificate of compliance for import visa 
and/or certificate of analysis for import licence.  
 Refusal to grant import authorization/ 
Application letter  
3. Importation of unregistered or unauthorized 
regulated products without special approval by the 
Authority  Rejection of the consignment and order the 
re-export or safe disposal of the product at the 
cost of the importer  
4. Manufacturing, importation, s ale, storage and 
distribution of substandard, unapproved, 
counterfeit/falsified, expired and fraudulent 
regulated products.  25% to 50% of the product value found in 
violation  
5. Obstruction of inspector from Rwanda Food and 
Drugs Authority  
` 100,000 Frw for  each day of obstructions  
6. Failure to re -export consignment that were 
recommended a re -exportation within the 
recommended timelines  10, 000 Frw for each extra day  
7. Sale, storage and distribution of food products in 
unauthorized premises  Not more than 5%  of value of the products  
8. Arrival of food products into the country without 
import Visa/License or special authorization;  Not more than 5% of the value of the products