Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
Doc. Ref. No.: FDISM/FDIEC/TRG/001 Rev_2    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REGULATIONS GOVERNING CONTROL OF IMPORTATION        
AND EXPORTATION OF PHARMACEUTICAL PRODUCTS 
AND MEDICAL DEVICES  
(Rwanda FDA law No. 003/2018 of 09/02/2018, Article 9)  
 
 
 
 
 
 
 
 
 
 
  
  
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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REGULATION DEVELOPMENT HISTORY  
  
DRAFT ZERO BY CONSULTANTS  11/06/ 2018  
ADOPTION BY RWANDA FDA  15/01/ 2019  
STAKEHOLDERS CONSULTATION  13/10/ 2022  
ADOPTION OF STAKEHOLDERS’ COMMENTS  14/10/2022  
DRAFT COMING INTO EFFECT  24/11/2022 
 
DOCUMENT REVISION HISTORY  
 
Date of revision  Revision 
number  Changes made and/or reasons for revision  
09/07/2020  0 First issue  
12/07/2021  1 Article 19.Validity of an Authorisation  
14/10/2022  2 1. Addition of the obligation to obtain an import Licence for 
importation  of investigational products in Article 6  
 
2. Article 14: Validity  of an Authorisation  
 
3. Addition of article 19 : Establishment of Advisory 
committee  
 
4. Addition of article 21 : Administrative sanctions  
 
5. Addition of article 22 : Appeal and review  
 
6. Addition of article 23 : Powers to issue guidelines  
 
7. Addition of Regulations development history section  
 
8. Addition of Document revision history Section  
 
9. Removal of articles about Requirements for 
pharmaceutical products and/or medical devices 
import/export authorizati on, packaging of imported 
products, container closure system and procedures for re -
export of pharmaceutical products and medical devices not 
allowed into Rwanda  
 
10. Correction of typographic errors and formatting.  
 
 
    
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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ADOPTION AND APPROVAL OF THE REGULATIONS  
 
In EXERCISE of the powers conferred upon Rwanda Food and Drugs Authority by Article No 9 of 
the Law No 003/2018 of 09/02/2018 establishing Rwanda FDA and determining its mission, 
organization and functioning, hereby ADOPTS and ISSUES these Regulations No . CBD/TRG/002 
Rev. No. 2, Governing Control of Importation and Exportation of Pharmaceutical Products and 
Medical Devices, made this 24/11/2022.  
 
 
  
  
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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ARRANGEMENT OF THE REGULATIONS  
 
REGULATION DEVELOPMENT HISTORY  ................................ ................................ ...................  2 
DOCUMENT REVISION HISTORY  ................................ ................................ ................................ . 2 
ADOP TION AND APPROVAL OF THE REGULATIONS  ................................ .............................  3 
ARRANGEMENT OF THE REGULATIONS  ................................ ................................ ...................  4 
CHAPTER I: GENERAL PROVISIONS  ................................ ................................ ...........................  5 
Article One: Purpose of these Regulations  ................................ ................................ ..........................  5 
Article 2: Citation  ................................ ................................ ................................ ................................  5 
Article 3: Application  ................................ ................................ ................................ ..........................  5 
Article 4: Definitions  ................................ ................................ ................................ ...........................  5 
CHAPTER II: IMPORTATION/EXPORTATION OF PHARMACEUTICAL PRODUCTS, 
MEDICAL DEVICES AND THEIR RESPECTIVE RAW MATERIALS  ................................ ........  7 
Article 5: Obligation to obtain an import Visa  ................................ ................................ ....................  7 
Article 6: Obligation to obtain an import/export Licence  ................................ ................................ ... 7 
Article 7: Special circumstances  ................................ ................................ ................................ ..........  7 
Article 8: Eligibility to import pharmaceutical products or medical devices  ................................ ...... 7 
Article 9: Eligibility to export pharmaceutical products or medical devices  ................................ ...... 8 
Article 10: Authorisation for importation/exportation of narcotic drugs and psychotropic  ................  9 
substances.  ................................ ................................ ................................ ................................ ...........  9 
Article 11:  Authorisation for importation/exportation of vaccines  ................................ ....................  9 
Article 12: Physical inspection of pharmaceutical products or medical devices or raw materia ls by 
the Authority  ................................ ................................ ................................ ................................ ........  9 
Article 13: Gazetted/approved ports of entry and exit  ................................ ................................ ....... 10 
CHAPTER III: VALIDITY, REFUSAL, SUSPENSION, AND WITHDRAWAL OF AN 
IMPORT/EXPORT AUTHORIZATION  ................................ ................................ ..........................  10 
Article 14: Validity of an Authorization  ................................ ................................ ............................  10 
Article 15: Refusal to grant an Authorization  ................................ ................................ ....................  10 
Article 16: Withdrawal of an authorization  ................................ ................................ .......................  11 
CHAPTER IV: RENEWAL AND VARIATION OF AN AUTHORIZATION  ...............................  11 
Article 17: Renewal of an import license  ................................ ................................ ..........................  11 
Article 18: Variation of an authorization  ................................ ................................ ...........................  11 
CHAPTER V: MISCELLANEOUS PROVISIONS  ................................ ................................ .........  11 
Article 19: Establishment of Advisory Committee  ................................ ................................ ...........  11 
Article 20: Compliance with other requirements  ................................ ................................ ...............  11 
Article 21: Administrative sanctions  ................................ ................................ ................................ . 12 
Article 22: Appeal and review  ................................ ................................ ................................ ...........  12 
Article 23: Power to issue guidelines  ................................ ................................ ................................  12 
Article 24: Revision of these Regulations  ................................ ................................ .........................  12 
Article 25: Commencement and repealing  ................................ ................................ ........................  12 
ANNEX A: FAULTS AND ADMINISTRATIVE SANCTIONS  ................................ ....................  13 
    
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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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 pharmaceutical products, medical devices, and their 
respective raw materials in a transparent, non -discriminatory man ner. 
 
Article 2 : Citation   
 
These Regulations may be cited as the “Regulations No DIS/TRG/002 Rev._2, Governing Control 
for Importation and Exportation of Pharmaceutical products and Medical Devices.”   
 
Article 3 : Application  
 
These regulations shall apply to the authorization of importation or exportation of pharmaceutical 
products, medical devices, and their respective raw materials for the public, private, non -profit 
organizations, and individuals as stipulated in Article 3 o f 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:  
 
“Authority”  means the Rwanda Food and Drugs Aut hority or its acronym “Rwanda FDA”, 
established under Article 2 of the Law No 003/2018 of 09/02/2018  determining its mission, 
organization and functioning.  
 
“Authorization”  means a legal document granted by Rwanda 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 visas, import/export licenses , permits, 
and certificates.   
 
Import Visa means an authorization /permit  issued to the importer  after confirmation by the Authority 
that manufacturer (s)/suppliers of pharmaceutical products or medical devices or their respective raw 
materials to be imported comply with international  and national  standards. The Import visa give s the 
right to the importer to confirm an order /purchase order  of the products  and to apply for import 
license.  
 
Import License  means an authorization /permit  issued to the importer by the Authority, authorizing 
him/her to import pharmaceutical products or medical devices or their respective raw materials into 
the country after complying with the  documentary  importation requirements;  
   
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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Export License  means an authorization /permit  issued to an eligible exporter by Authority,  
authorizing him/her to export pharm aceuticals or medical devices  or their respective raw materials 
from the country;  
 
“To Whom it may concern” means a special authorization /permit  issued to an eligible 
importer/exporter by Authority, authorizing him/her to import/export pharmaceutical  products  or 
medical devices or their respec tive raw materials for specific  reasons  including but not limited to 
products for disasters, emergency and outbreaks officially declared by competent authority ; 
 
“Fee”  means the regulatory service charge  prescribed in the Fees Regulations in accordance with 
Article 9 and Article 32 of the Law No 003/2018 of 09/02/2018.  
 
“Good Manufacturing Practice”  means that part of Quality Management which ensures that 
products are consistently produced and controlled  to the quality standards appropriate to their 
intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or 
product specification. Good Manufacturing Practice is concerned with both production and quality 
control.  
 
“Manufac turer”  means a person or corporation, or other entity engaged in the business of 
manufacturing pharmaceutical products and/or medical devices;   
 
“Pharmaceutical product”  means any substance in its finished dosage form, or as a starting 
material for use in  such a dosage form, capable of preventing, or treating human or animal diseases 
and any other substance intended for administration to a human being or an animal in order to 
diagnose diseases, restore, correct or carry out modification of organic or menta l functions. It also 
means products used in disinfecting premises where food and pharmaceutical products are 
manufactured, prepared, or stored, cleaning hospitals, equipment, and farmhouses.  
 
“Pharmacy”  means any licensed/authorized location used for the p ractice of the pharmacy 
profession.  
 
“Premises”  means any plot of land, buildings or boats, aircraft, 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.  
 
“Medical device”  means any instrument, machine, appliance, or material intended by the 
manufacturer to be used alone or in combination for the purpose of diagnosis, testing, vaccination, 
cure, surgery, for human or animal health p rotection;   
 
“Investigational product”  means any drug, biological product, device, or placebo being tested or 
used in a clinical trial/research.  
 
“Raw material ” refer s to any unfinished substance  used to manufacture medical devices or 
pharmaceutical products including vaccines.  
   
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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“Unapproved regulated products”  refers to regulated products  not yet released  by the authority 
including but not limited to imported pharmaceutical products, medical devic es and their respective 
raw materials that are uninspected  (not yet physically inspected at ports of entry or at importer’s 
premise for consignments released under seal) or unauthorized for use  by the Authority . 
 
In these Regulations, the following verbal f orms are used:   
 
“shall”  indicates a requirement;  
“may”  indicates a permission; and   
“can”  indicates a possibility or a capability.  
 
CHAPTER II: IMPORTATION/ EXPORTATION  OF PHARMACEUTICAL PRODUCTS, 
MEDICAL DEVICES  AND THEIR RESPECTIVE RAW MATERIALS  
 
Article 5 : Obligation to obtain an i mport Visa  
 
Any person intending to import any pharmaceutical product or medical device  or their respective 
raw materials  and investigational products shall apply for an Import Visa for each consignment, 
issued by the A uthority in accordance with these Regulations. The requirements to apply for import 
visa are provided in the guidelines for importation and exportation of pharmaceutical products and 
medical devices.  
 
Article 6 : Obligation to obtain an import/export Licenc e  
 
Any person intending to import/export any pharmaceutical product, medical device  or their 
respective raw materials  and investigational product s shall apply for an import/export license for 
each consignment, issued by the Authority in accordance with th ese Regulations. The requirements 
to apply for import/export license are provided in the guidelines for importation and exportation of 
pharmaceutical products and medical devices.  
 
Article 7: Special circumstances  
 
In special circumstances including but no t limited to products for personal use, disasters, 
emergency and outbreaks of ficially declared by competent a uthority the article 5 and/or 6 shall not 
be applied. The requirements to apply for import/export permit of products for personal use are 
provided in the guidelines for importation and exportation of regulated products declared as 
personal effects.  
 
Article 8 : Eligibility to import pharmaceutical products or medical devices  
 
Eligible applicants to imp ort pharmaceutical products, medical devices , and their respective raw 
materials for their manufacture  include:  
 
1°. A manufacturer of pharmaceutical products or medical devices;    
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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2°. A wholesaler of pharmaceutical products or medical devices;  
3°. A retail er of pharmaceutical products and medical devices can import the products 
based only on medical prescription in case  the products are  not available on the local 
market;  
 
4°. A beneficiary of pharmaceutical products or medical devices donation;  
 
5°. Government in stitutions  (examples: Ministries, Teaching and Referral Hospitals, 
Universities, etc.)  
 
6°. Public and Private Health Facilities with justified reasons  
 
7°. Research institutions/researchers with clinical trial or research approval in the 
country;  
 
8°. UN agencies, in ternational organizations intervening in health sector, Non-
governmental organizations (NGOs) with MOU with Ministry of Health (MOH) or 
Government of Rwanda;  
 
9°. A tourist, a visitor in the country or any oth er person with  justified reasons;   
 
10°. Hatcheries  
 
NB: Registered pharmaceutical products or medical devices by Rwanda FDA shall be imported 
only by the marketing authorization holder’s Local Technical Representative (LTR) or by any other 
company appointed by the marketing authorization holder or by the manu facturer in case he/she is 
the marketing authorization holder . 
 
Article 9 : Eligibility to export pharmaceutical products or medical devices   
 
Eligible applicants to exp ort pharmaceutical products, medical devices and raw materials  include :  
 
1°. A manufacturer of pharmaceutical products or medical devices;  
 
2°. A wholesaler of pharmaceutical products or medical devices;  
 
3°. A donor of pharmaceutical products or medical devices;  
 
4°. Government institutions (examples: Ministries, Teaching and Referral Hospitals, 
Universities, etc.) with justif ied reasons  
 
5°. Public and Private Health Facilities with justified reasons  
   
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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6°. Research institutions/researchers with clinical trial or research appro val in the 
country;  
 
7°. Non-governmental organizations (NGOs) with MOU with Ministry of Health (MOH) 
or Government of Rwanda;  
 
8°. UN organizations and other international organizations intervening in Health sector;  
 
9°. A tourist, a visitor in the country or any other person for justified reasons.  
 
Article 10 : Authorisation for importation/exportation of narcotic drugs and psychotropic  
                   substances.  
 
Any person intending to import/export any narcotic dr ugs or psychotropic substances shall apply 
for an official certificate of importation/exportation of controlled substances, issued by the 
Authority in accordance with these Regulations.  
 
The Authority shall issue an official certificate of importation/exp ortation of controlled substances 
where it is satisfied that the applicant meets the requirements and any applicable national and/or 
international laws.   
Any person granted an authorization to import/export a narcotic drug or psychotropic substance 
shall provide quarterly reports to the Authority.  
 
Article 11 :  Authorisation for importation/exportation of vaccines   
 
Any person intending to import/export any vaccine and/or its active substance including master and 
working cell banks shall apply for importat ion/exportation authorization issued by the Authority in 
accordance with these regulations.  
 
These regulations therefore concern import/export of either finished vaccine in its final form or any 
product essential for its manufacturing. This includes the ac tive substance (commonly called drug 
substances or bulk, intermediates, master and working cell banks), the vaccine in a bulk packaging , 
the vaccine in its primary and /or secondary packaging.     
 
Article 12 : Physical inspection  of pharmaceutical products  or medical devices  or raw 
materials by  the Authority   
 
All imported consignments of pharmaceutical products and medical devices shall be subjected to 
physical inspection at port of entry or at importer’s premise for the consignments released under seal 
before being used to ensure that they comply with claimed specifications. The Authority may take 
samples for quality control testing.  Consignments to be exported shall be subjected also to physical 
inspection.  
   
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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The products which do not conform to importation requirements shall be rejected. Where the 
Authority rejects imported pharmaceutical products/medical devices /raw materials  for reasons 
other than their quality, the  importer of the rejected product  shall re -export them to  the country of 
origin, within a period of ninety (9 0) days from the date of the rejection. The cost related to this 
exercise is paid by the importer.  Where the Authority rejects imported pharmaceutical 
products/medical devices /raw material s, due to reasons of poor quality, they shall be destroyed at 
the c ost of the importer within ninety (90) days  from the date of rejection following the procedures 
for safe disposal.  
 
The Authority reserves the right, when deemed necessary and for justified r easons, to release 
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.  
 
No person shall obstruct or hinder Rwanda FDA inspec tors in the exercise of their powers or 
performance of their duties as provided for in the Law.  
 
Article 13 : Gazetted/approved ports of entry and exit  
 
Pharmaceutical products/medical devices /raw materials  shall be imported or exported only through 
Gazetted /approved  ports of entry and exit.  
 
CHAPTER III: VALIDITY, REFUSAL, SUSPENSION, AND 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/exp ort License shall be valid for 6  months from the date of its issuance  
 
3°. An official certificate of importation/exportation of controlled substances shall be valid 
for 12 months from the date of  its issuance  
 
4°. An authorization is issued to an applicant, to cover only one  consignment, and shall not 
be transferable.   
 
Article 15 : Refusal to grant an Authorization  
 
An authorization to import/export shall not be granted where the Authority finds  that the applicant 
is not complying with the importation /exportation requirements.  
 
 
   
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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Article 16 : Withdrawal of an authorization  
 
An au thorization may be withdrawn where the Authority finds that the applicant violated any of 
the conditions under which authorization was granted for or has ceased to be fit to carry out the 
business. The notice of suspension or withdrawal shall be issued by the Authority to the applicant.  
 
 
CHAPTER IV: RENEWAL AND VARIATION OF AN AUTHORIZATION  
 
Article 17 : Renewal of an import license  
 
An import Lice nse shall be renewed after six  months from the date it was issued in case it has not 
been used by the applicant upon submission of an application for renewal.  
 
Article 18 : 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 a reasonable time.   
An application shall be made to the Auth ority for review and approval of any variation made on 
the details of the issued authorization.  
 
CHAPTER V: MISCELLANEOUS PROVISIONS  
 
Article 19 : Establishment of Advisory Committee  
 
1°. The Authority shall establish Import and Export Control Advisory Committees with 
clear terms of reference;  
 
2°. The committees shall be composed of internal and external multidisciplinary experts 
with specialization in relevant fields to assess all safety and quality issues on 
importation and exporta tion of Pharmaceutical p roducts, medical devices  and their 
respective raw materials . 
Article 20 : 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.  
 
 
 
   
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Article 21: Administrative sanctions  
 
Any person who contravenes the provisions of these Regulations, shall be liable to the 
administrative  
measures and sanctions under Annex A : 
1°. Manufacturing, importation, sale, storage and distribution of substandard, unapproved, 
counterfeit/falsified, expired and fraudulent regulated products.  
2°. Importation/Exportation of unregistered or unauthorized regulated products without 
special approval given by the Authority  
3°. Obstruction of inspectors from Rwanda Food and Drugs Au thority  
4°. Failure to re -export consignment that were recommended for re -exportation within the 
recommended timeline  
 
Article 22 : Appeal and review  
 
1°. Any person aggrieved by a decision of the Authority may apply to the Authority for 
review of the decision sho wing grounds for dissatisfaction 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.  
 
If a person is dissatisfied with the decis ion after review, he may appeal to the Minister 
whose decision shall be final.  
 
Article 23 : Power to issue guidelines  
 
The authority shall issue Guidelines, Standards Operating Procedures, forms and formats 
necessary for the implementation of these Regulations.  
 
Article 24 : 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. Amendments shall be communicated to the 
public in due time.  
 
Article 25 : Commencement and repealing  
 
These regulations come into force on the date of signature and publication by the Authority.  
All p rovisions contrary to these regulations are hereby repealed.  
 
End of Document  
 
   
Regulations Governing Control of Importation and Exportation of 
Pharmaceutical Products and Medical Devices  
 
 
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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 license . Warning letter  
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 license . Refusal to grant import author ization/ 
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 of the product at the cost of the 
importer  
4. Manufacturing, importation, sale, 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