Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 1 of 20  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GUIDELINES FOR IMPORTATION AND EXPORTATION OF 
PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES  
 
 
 
 
 
 
 
 
 
NOVEMBER , 2022  
 
 
 
 
 
 
 
 
 
 
 
Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 2 of 20 FOREWORD  
 
 
 
 
 
 
 
 
 
 
 
 
Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 3 of 20 GUIDELINES DEVELOPMENT HISTORY  
 
DRAFT ZERO  02/06/ 2021  
ADOPTION BY RWANDA FDA  11/06/ 2021  
STAKEHOLDERS CONSULTATION  18/06/ 2021  
ADOPTION OF STAKEHOLDERS’ COMMENTS  25/06/ 2021  
DATE FOR COMING INTO EFFECT  30/11/2022  
 
Document Revision History  
Date of revision  Revision 
number  Changes made and/or reasons for revision  
13/07/ 2021  0 First issue  
17/10/2022  1 1. Requirements for import visa of registered products: 
certificates of compliance to international standards such as 
GMP, ISO, IEC, CE, etc. are not required.  
 
2. Requirements for import visa and license for non -registered 
products: COAs is no longer required if the manufacturer is 
located in a country with stringent regulatory authority and 
GDP or Operational license of the supplier can replace 
certificates of comp liance to international standards such as 
GMP, ISO, IEC, CE, etc.  
 
3. The application processing time has been updated  
 
4. The validity for import/export license has been updated  
 
5. The validity for official certificate of importation of 
controlled substances has  been updated  
 
6. The condition s for re -exportation of rejected consignment 
have been added  
 
7. The application processing chart/diagram was added  
 
  Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 4 of 20 TABLE OF CONTENTS  
 
FOREWORD  ................................ ................................ ................................ ...............................  2 
GUIDELINES DEVELOPMENT HISTORY  ................................ ................................ .............  3 
Document Revision History  ................................ ................................ ................................ ........  3 
ACRO NYMS AND ABBREVIATIONS  ................................ ................................ ....................  5 
Definitions  ................................ ................................ ................................ ................................ ... 6 
1. Introduction  ................................ ................................ ................................ ...................  8 
2. Scope  ................................ ................................ ................................ .............................  8 
Chapter 1. Importation of Pharmaceutical Products and Medical Devices/IVDs  .......................  9 
1.1 Requirements  ................................ ................................ ................................ ....................  9 
1.1.1  General requirements  ................................ ................................ ................................ ........  9 
1.1.3  Specific requirements  ................................ ................................ ................................ ..... 10 
1.1.3.1  Import visa requirements  ................................ ................................ ............................  10 
1.1.3.2  Import license requirements  ................................ ................................ ........................  12 
1.1.3.3  Import license of controlled substances  ................................ ................................ ...... 13 
1.1.3.4  Conditions for the importation of donate d pharmaceutical products or 
medical/IVDs.  ................................ ................................ ................................ ............................  13 
1.1.3.5  Inspection of imported consignments at ports of entry  ................................ ...............  14 
a) Sampling of imported products  ................................ ................................ ......................  15 
b) Release of consignments  ................................ ................................ ................................ . 15 
c) Rejection of consignments  ................................ ................................ ..............................  15 
Chapter 2: Exportation of Pharmaceutical Products and Medical Devices/IVDs  .....................  16 
2.1 General requirements  ................................ ................................ ................................ ...........  16 
2.2 Eligibility for Export Autorization  ................................ ................................ .................  16 
2.3 Requirements for exportation of pharmaceutical products and medical devices/IVDS  . 16 
2.4 Application processing flow chart  ................................ ................................ ..................  17 
References  ................................ ................................ ................................ ................................ .. 18 
ENDORSEMENT OF THE GUIDELINES  ................................ ................................ ..............  19 
ANNEXES  ................................ ................................ ................................ ................................ . 20 
 
 
 
 
 
 
 
 
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 5 of 20 ACRONYMS AND ABBREVIATIONS  
 
CE : Conformité Européenne  
COA:  Certificate of Analysis  
GDL :  Guideline  
GDP: Good Distribution Practice  
GMP :  Good Manufacture practices  
IEC:  International Electrotechnical Commission  
ISO: International Organization for Standardization  
IVDs: In -Vitro Diagnostics  
ME: Medical Electrical  
MoU: Memorandum of Understanding  
NGOs: Non -Government Organizations  
PoE: Port of Entry  
PEMS: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS  
PRIMS : Pharmaceutical Regulatory information system  
RESW: Rwanda Electronic Single Window  
Rwanda FDA : Rwanda Food and Drugs Authority  
RFID: Radio Frequency Identification  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 6 of 20 Definitions  
 
In these guidelines, unless the context otherwise states:  
 
Authority  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  establishing Rwanda Food 
and Drug Autority and determining its mission.  
 
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 vis as, impo rt/export 
licenses, permits,  certificates , and other types of approval as may be issued by the Authority.  
 
Consignment  means a number  of goods that are sent to a person or place to be sold;  
 
Donation  means an act or instance of presenting medical products, processed foods, and 
others;  
Products regulated to recipients in an emergency or as a part of development aid in non -
emergency situations;  
 
Exporter  means a person, country, or organization that sends goods or services to another 
country;  
 
Expo rt License  means an authorization/permit issued to an eligible exporter by Authority, 
authorizing him/her to export pharmaceuticals or medical devices or their respective raw 
materials from the country;  
 
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.  
 
Importer  means a person or organization that brings goods or services into a country from 
abroad;  
 
Import License  means an authorization/permit issued to t he 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 importation requirements;  
 
Import Visa  means an authorization/permit issued to the importer after confirmation by the 
Authority that the manufacturer(s)/suppliers of pharmaceutical products or medical devices or 
their respective raw materials to be imported comply with international and nation al standards. 
The Import visa gives the right to the importer to confirm an order /purchase order  of the 
products and to apply for an import license.  
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 7 of 20 Manufacturer  means a person or corporation, or other entity engaged in the business of 
manufacturing pharm aceutical products and/or medical devices /IVDs ;   
 
Medical device/IVDs  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, or for human or animal health protection. A medical device is an 
in vitro diagnostic device (IVDs) if it is a reagent, calibrator, control materials, kit, specimen 
receptacle, software, instrument, apparatus, equipment, or system, whether used alone or in 
combination with other diagnostic good for in vitro use which is used during the examination 
of specimens derived from the human body.  
 
Pharmaceutical product  means any substance in its finished dosage form, or as a starting 
material for use in such a dosa ge 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 mental 
functions.  It also means products used in disinfecting premises where food and pharmaceutical 
products are manufactured, prepared, or stored, cleaning hospitals, equipment, and 
farmhouses.  
 
Raw materials  mean any substance of a defined quality used in the production  of a 
pharmaceutical product and medical devices, but excluding packaging materials;  Controlled 
substances mean any narcotic drug, psychotropic substance, or precursor as described under the 
Law n° 03/2012 of 15/02/2012 governing narcotic drugs, psychotrop ic substances, and 
precursors in Rwanda.  
 
Special import authorization  refers to  an import  authorization issued for unregistered 
/unauthorized pharmaceutical products / medical devices/IVDs . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 8 of 20 1. Introduction  
 
The safety, efficacy, and quality of pharmaceutical p roducts and medical devices/IVDs  can be 
highly affected by the lack of adequate control on importation and exportation. It is therefore 
imperative that the manufacture, importation, and exportation of pharmaceutical p roducts and 
medical devices/IVDs , both nationally and internationally conform to certain set standards.  
The Authority has developed these guidelines to strengthen the control of the importation and 
exportation of these products and to assist those in the field to adhe re to the legal framework 
during importation and exportation activities.  
The main objective of these guidelines is to provide importers and exporters of 
pharmaceuticals and medical devices/IVDs  with the necessary information to enable them to 
comply with t he law and regulations governing the control of the importation and exportation 
of these products.  
These guidelines are organized into two modules.  
The first module provides for the requirements and conditions to fulfi ll during the importation 
of pharmace uticals and medical devices/IVDs  while the second module outlines the 
requirements and conditions for the exportation of these products.  
 
2. Scope  
 
These guidelines apply to pharmaceutical p roducts, medical devices/IVDs,  and their 
respective raw materials as specified in the law N0 47/2012 of 14/01/2013 relating to the 
regulation and inspection of food and pharmaceutical products and law No 03/2012 of 
15/02/2012 governing Narcotic drugs, Psychotropic substances, and precursors in Rwanda.  
These guidelines outline requirements for the importation and exportation of pharmaceutical 
products and medical devices/IVDs  for human beings or animals . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 9 of 20 Chapter 1. Importation of Pharmaceutical Products and Medical Devices/IVDs  
 
1.1 Requirements  
 
1.1.1 General requirements  
 
All pharmaceutical products, medical devices/IVDS to be imported must be registered or 
granted special approval by the Authority.  
Any import application passes through two mandatory phases; Visa and License whereby Visa 
is the starting phase.  
 
All application s of importation/ exportation of pharmaceutical products and medical 
devices/IVDs for personal use is guided by Guidelines NO FDSIM/FDIEC/GDL/004  
Importation and Exportation of regulated products declared as personal effects.  
 
All imported pharmaceutical p roducts and medical devices/IVDs  (where applicable) must 
have at least two -thirds of their shelf life remaining when they arrive at the port of e ntry and 
must comply with applicable labeling and packaging requirements.  
The product information leaflet/catalog enclosed in or accompanying the pharmaceutic al 
product, medical devices/IVDs , shall be in officially recognized languages in Rwanda.  
 
The impo rtation of a pharmaceutical product labeled for sale in a specified country is 
prohibited in Rwanda except where Rwanda is one of the specified countries.  
All applications for import authorization shall be submitted using a platform defined by the 
Authorit y. 
 
All consignments of pharmaceutical products and medic al devices/IVDs  shall pass through 
the approved port of entry . 
 
All imported consignments of pharmaceutical products and medical devices/IVDs shall be 
subjected to physical inspection at the port of entry or at the importer’s premise (for the 
consignments released under seal) before being used, to ensure that they comply with claimed 
specifications.  
 
Apart from the specific requirements for importation/exportation, t he Authority reserves the 
right, wh en deemed necessary and for justified reasons, to request the importer to provide any 
other document/information for further analysis.  
 
 
 
 
 
 
 
 
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 10 of 20 1.1.2 Eligibility for Import  Authorization  
 
All pharmaceutical products and medical devices/IVDs must be imported by importers whose 
premises are licensed by Rwanda FDA or who fall within the eligible importer category. Only 
the following shall be allowed to import pharmaceutical products and medical devices/IVDs:  
 
a) Licensed manufacturers and wholesale companies of pharma ceutical and medical 
devices/IVDs . 
b) Licensed retail of pharmaceutical and medical devic es/IVDs  (only on medical 
prescription) in case the product is not available on the market.  
c) Public and private health facilities.  
d) Hatcheries  
e) The beneficiary of a donation.  
f) Non-governmental organizations (NGOs) with a Memorandum of Understanding (MOU) 
with the Ministry of Health or Government of Rwanda.  
g) Government institutions and Embassies.  
h) UN organizations intervening in the Health sector.  
i) Clinical Trial Sponsors and Princ ipal Investigators.  
j) A tourist, a visitor in the country, or any other person for justified reasons.  
 
Any medical/IVDs device and pharmaceutical products shall be clearly labeled depending on 
their nature and type. The label should have the following minimu m information:  
 The trade or brand name;  
 The generic name of the pharmaceutical products and/or medical devices where 
applicable;  
 The quantities of active ingredients in the pharmaceutical products/or medical devices 
where applicable;  
 The dates of manufacture and expiry where applicable;  
 The batch or lot number/serial or model number;  
 Special storage conditions and handling requirements where applicable;  
 The name and address of the manufacturer where applicable;  
 Any other safety information , depending on the nature of the product.  
 
The labeling  information may be provided in a human -readable code or through automatic 
identification technology such as barcodes or Radio Frequency Identification ( RFID)  
 
1.1.3 Specific requirements  
 
1.1.3.1  Import visa requir ements  
 
Any import application starts from a step called import visa. The import visa gives the right 
to the importer to confirm an order for the products to be imported.  
The following requirements are mandatory to apply for an import visa:  
 
 
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 11 of 20 a) Registered pharmaceutical p roducts and medical devices/IVDs  
 
i) A Proforma invoice showing:  
 Invoice number and date,  
 Manufacturer name,  
 Address of exporter and importer companies,  
 Country of origin of the manufacturing site for each product,  
 A clear description of e ach product including brand and common names as they 
appear on Rwanda FDA registers of medicinal products or medical devices/IVDs . 
 Quantity and value for each product in convertible currency  
 
ii) The operational license of the importer (if applicable)  
 
b) Special import authorization approval  
 
The special import authorization is issued for unregistered /unauthorized pharmaceutical  
products / medical devices/IVDs  in the following conditions:  
 
 If the imported pharmaceutica l products/ medical devices/IVDs  have  no 
registered/authorized therapeutic equivalent (alternative) products available in 
Rwanda with valid reasons for import (orphan medicines, medicines for emergenc y 
use, and medicines for specific treatment including but not limited to cancer).  
 The importation of pharmaceutical p roducts and medical devices/IVDs  to be used in 
the clinical  trial. 
 
i) A proforma invoice showing:  
 Invoice number and date,  
 Manufacturer name,  
 Address of exporter and importer companies,  
 Country of origin of the manufacturing  site for each product,  
 A clear description of each product including brand/trade and common names, 
strength, dosage form, and pack.  
 Quantity and value for each product in convertible currency  
ii) The operational license of the importer (if applicable)  
 
iii) For pharmaceutical products:  Valid Good Manufacturing Practices certificate (GMP) 
if the manufacturer is not located in a country with stringent regulatory authority or Valid 
Good Distribution Practices certificate (GDP) or Operational License of the suppl ier if 
the manufacturer is located in a country with a stringent regulatory authority.  
 
iv) For medical devices/IVDs : Proof of compliance to the international standards or 
European Community standards (ISO or CE certificate or IEC) issued by an accredited 
certifying/notified body or Valid Good Manufacturing Practices certificate (GMP) if the 
manufacturer is not located in a country with stringent regulatory authority or Valid Good 
Distribution Practices certificate (GDP) or Operational License of the supplier i f the 
manufacturer is located in a country with stringent regulatory authority or certificate of Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 12 of 20 refurbishmen t( for used medical devices/IVDs ) issued by the manufacturer or certified 
company.  
 
v) Clinical trial approval certificate or ethical committee approv al/certificate or approval 
from government institutions (for veterinary research) in case of investigational products 
and related trial products ,  an application form [FDISM/FDIEC/FOM/003] shall be filled 
and submitted during application.  
 
The ap plication will be processed in 3  working days, and any application which does not meet 
any of the im portation requirements will be rejected . An applicant will be notified by the 
Authority stating clearly the reason(s) for rejection.  
 
The import visa, for a specific consignment,  shall  be valid for six (6) months from the date of 
issue.  
The official certificate of importation of controlled substances  [DIS/FMT/119] is valid for 
twelve (12) months from the date of issue.  
 
1.1.3.2  Import license requirements  
 
a) The c ommercial invoi ce ha s the following information:  
 Invoice number and date,  
 Manufacturer name,  
 The address of exporter and importer companies,  
 Country of origin of the manufacturing site for each product,  
 A clear description of each product including brand and common names as they appear 
on Rwanda FDA registers of medicinal products.  
 Quantity, and value for each product in convertible currency  
 
b) Donation certificate/letter with the total value of donated health commodity where 
applicable  
 
c) Clinical trial approval certificate or ethical committee approval/certificate or approval 
from government institutions (for veterinary research) in case of investigational products 
and related trial products , an application form [FDISM/FDIEC/FOM/003] shall be filled 
and submitted  during application.  
 
d) A packing list of the medical products (if applicable) with the following information:  
 Imported quantities.  
 Batch/lot number or the Model number for med ical device /IVD s and expiry date where 
applicable.  
 
e) Certificate of analysis for p harmaceutical products or Medical devices/IVDs ( where 
applicable) certificates of conformity for each batch /model of medical devices/ IVDs  if 
the manufacturer is not located in a country with a stringent regulatory authority.  
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 13 of 20 f) A Proof of Payment of verifi cation fees as specified in the Regulations governing services 
fees, tariffs, and fines.  
 
The ap plication will be processed in 3  working days, and any application which does not meet 
any of the importation r equirements will be rejected . An applicant will be notified by the 
Authority stating clearly the reason(s) for rejection.  
 
The import license [DIS/FMT/122  ]is granted for a single consignment, valid for six (6) months 
from the date of issue and it is renewable  for 3 months in case it has not been used . 
 
1.1.3.3  Import license of controlled substances  
 
An application for a narcotic, psychotropic, and precursor substances import license is made 
by a person issued with an official certificate of importation/exportation of controlled 
substances [DIS/FMT/119]  under art icle 10 of the regulation governing control of importation 
and exportation of pharmaceutical products and medical devices/IVDs.  For cannabis and 
cannabis products, requirements and eligibilities are indicated in regulations for the 
importation and exportat ion of cannabis and cannabis products [CBD/TRG/020 Rev_0]  
 
In the case of controlled drugs (narcotics, psychotropics, and precursors), a proforma invoice 
will be accompanied by an import certificate from a drug regulatory authority of an importing 
country.  
Note that t he requirements to apply for an official certificate of importation of controlled 
substances are the same as those required to get an import visa for pharmaceutical products.  
 
1.1.3.4  Conditions for the importation of donated pharmaceutical products or  
medical/IVDs.  
 
In addition to the above -mentioned requirements to apply for an import visa and import 
license, the following conditions shall be fulfilled for the importation of donated 
pharmaceutical products and medical devices/IVDs:  
a) All applicants intending to export donated pharmaceutical products and medical 
devices/IVDs to Rwanda, apart from registered products or those granted special 
approval by the authority, shall apply first for a donation acceptance letter as per the 
guidelines  No DAR/GDL/0 40 for Donation of Medical Products.  
b) All Donations will be in accordance with the recipient’s need and should comply with 
the existing government policies, laws, guidelines, and administrative arrangements.  
 
c) Donations should comply with applicable standards and there will not be double 
standards regarding the quality of donated items. Unacceptable medical devices/IVDs, 
and pharmaceutical products in the donor country shall not be allowed into the 
recipient’s country.  
 
d) Any person, institution, or organization intending to import donated pharmaceutical 
products, and medical devices/IVDs will be required to apply for import permit 
authorization.  Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 14 of 20  
e) The application for an import visa should be accompanied also by the following 
documents:   
A supporting docu ment from the relevant institution which supports such donation (if 
applicable).  
 
i) A donation certificate/letter from the donor to the beneficiary.  
ii) Donation acceptance letter issued by the Authority , the corresponding requirement 
can be found in Guidelines for Donation of Medical Products [ DAR /GDL/ 0 40 ] 
iii) Certificate of refurbishment (for used medical devices/IVDs) issued by the 
manufacturer or certified company.  
 
f) Donated medical devices/IVDs, or pharmaceutical products should have a shelf life of 
not less than 2/3 of the original shelf life or 80% for products with a shelf life of less 
than 24 months.  
 
g) If the medical equipment/instrument is used, it must be recondi tioned and tested and 
all essential parts, accessories, and working materials included before shipment 
together with the relevant supporting documents to indicate that the device is in good 
state 
 
h) For software -operated medical devices/IVDs, the software sh all be either preloaded 
and/or accompanied by the software package.  
 
i) For medical electrical equipment, the electrical needs of the equipment shall be set to 
the standard voltage of 220V/50Hz, and for X -ray emitting equipment it shall be 
calibrated and ins pected by a qualified Medical Physician.  
 
j) Damaged, outmoded, and redundant medical devices/IVDs for which spare parts and 
consumables are no longer available will not be accepted.  
 
k) Donated medical devices/IVDs and pharmaceutical products must meet the labeling 
requirement s. 
 
1.1.3.5  Inspection of imported consignments at ports of entry  
 
Each consignment of pharmaceutical products and medical devices/IVDS must be inspected 
by the authority at the port of entry to ensure that it complies with the approved requirements 
and applicable regulations.  
The consignment must be accompanied by the following requirements:  
 A valid import license issued by the Authority.  
 A corresponding commercial invoice.  
 A certificate of analysis for each batch or a certificate of co nformity (if applicable).  
 
The imported pharmaceutical products and medical devices/IVDs  (if applicable) must have at 
least 2/3 of their shelf life remaining on arrival at the port of entry.  Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 15 of 20 If the consignment contains controlled substances, it must be acc ompanied by an export 
authorization from a competent authority.  
 
a)  Sampling of imported products  
 
The inspector at the port of entry may take samples of pharmaceutical products or medical 
devices/IVDS for further investigation during the inspection and rele ase of the consignment 
in case of suspected poor -quality product  reporting form [FDISM/PVSM/FOM/016]  or in case 
of routine sampling.  
In the case of routine sampling, the consignment from which the samples have been taken 
shall be released to the importer fo r distribution if they meet all the quality requirements.  
Suspicious consignment in which a sample was taken for analysis, shall not be released and 
shall not be distributed until the laboratory results are available for decision -making.  
An inspection repo rt will be written for that purpose.  
 
b) Release of consignments  
 
At the port of entry , the inspector shall release the consignment if it meets the quality , 
documentary, and physical verification  requirements for the importation of pharmaceutica l 
products, medical devices/IVDs , and diagnostics by stamping the supporting documents 
“APPROVED ”. 
In case the physical inspection cannot be conducted at the port of entry for example: for intra -
region consignments, consignments that require special storage conditions , or consignments 
that cannot be offloaded at the port of entry, the inspector releases the consignment underseal 
(by stamping supporting documents “ RELEASED UNDERSEAL ” and filling the form 
[DIS/FOM/151 ] for further inspection at importer’ s premise.   
For the partial shipment, an inspector will write " PARTIAL SHIPMENT " on the import 
license and invoice, along with the imported and remaining quantities.  
 
c)  Rejection of consignments  
 
i) If the consignment does not meet importation requirements, it shall be reject ed and 
follow the procedure for re -export and the exercise will be done within 90 days . The 
following are the reasons for the re-export of a consignment:  
 Pharmaceutical products or med ical devices/IVDs  not meeting the labelling 
specifications.  
 Pharmaceutic al products or medical devices/IVDs  are not allowed or withdrawn from 
the Rwanda market.  
 Any other reason the authority may deem necessary.  
 
ii) If a consignment is rejected due to quality and/or safety reasons, the applicant will 
proceed for safe disposal. The application for safe disposal shall be done within one 
month. The Rejected product will get a full release in the Rwanda electronic single 
window (Resw) after the submission of the destruction /disp osal certificate.   
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 16 of 20 iii) Where the consignment is rejected/detained, an inspector will fill minutes of inspection 
findings / PV de constat  [FDISM/FDIC/FOM/004] with recommendations to follow 
safe disposal measures  where applicable . 
 
Chapter  2: Exportation of Pharmaceutical Products and Medical Devices/IVDs  
 
2.1 General requirements  
 
Exporters  of pharmaceutical products and medical devices/IVDs  should have a valid export 
authorization issued by the Authority.  
All consignments of pharmaceutical  products / medical devices/IVDs  to be exported must go 
through the authorized port of entry (PoE)/Exit.  
 
2.2 Eligibility for Export  Autorization  
 
Eligible applicants to export pharmaceutical products and medical devices/IVDS include:  
a) A manufacturer of pharm aceutical products or medical devices/IVDS;  
b) A wholesaler of pharmaceutical products or medical devices/IVDS;  
c) A donor of pharmaceutical products or medical devices/IVDS;  
d) Referral Hospitals, Government institutions;  
e) Private Health Facilities with justifie d reasons;  
f) Research institutions/researchers with clinical trial or research approval in the country;  
g) Non-governmental organizations (NGOs) with MOU with the Ministry of Health 
(MOH) or Government of Rwanda;  
h) UN organizations and other international organi zations intervening in the health sector;  
i) A tourist, a visitor in the country , or any other person for justified reasons.  
 
2.3 Requirements for exportation of pharmaceutical products and  medical devices/IVDS  
 
All applications for an export license shall be accompanied by the following documents:  
 
a) Invoice of the product to be exported including the following information:  
 Name and address of the exporting and address of importing companies,  
 Invoice number and date,  
 A clear description of items with the quantity and values of the product to be 
exported.  
In the case of controlled drugs (narcotics, psychotropics, and precursors), the invoice will be 
accompanied by an import certificate from a drug regulatory authority of an importing country.  
 
b) Certificate o f analysis for every batch with details of tested parameters, if applicable.  
c) A Packing List with the following details: Batch Number or model number for medical 
equipment and Manufacturing & Expiry dates, quantity, and value of the category item 
to be exported.  
d) Operational license  of the exporter.  
e) Proof of Payment of verification fees as specified in the Regulation governing services 
fees, tariff s, and fines.  Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 17 of 20 f) Evidence of the source of the products to be exported, if applicable.  
 
An export license  [DIS/F MT/125 ] shall not be transferable and shall be issued to cover only 
one shipment and  the license will be valid for six (6 ) months from the date of issuance.  
NB: All applications for export License shall be submitted using a platform defined by the 
Authori ty and will be processed within  3 working days . 
 
2.4 Application process ing flow chart  
 
Upon submission of the application via email or the online portal , the Authority will verify the 
eligibility and completeness of the application dossier. The application screening is done as 
indicated in the diagram of Figure 1.  
 
 
Figure 1:  Application processing scheme  
 
 In the event that the application does not comply with guidelines and regulations, a query will 
be submitted back to the applicant.  
A regulatory decisio n is made based on the outcome of the assessment of the submitted 
dossier. Based on the type of application, a processing period has been allocated (as indicated 
in sections 4.3 and 3.1). However, the  stop-clock starts whenever a query is raised and ends 
when a satisfactory response is received from the applicant. Applicants are reminded to ensure 
the application fulfi lls ALL  the eligibility criteria and that all the required information is 
entered correctly and accurately. Any application which fails to fulfill ALL  the eligibility 
criteria specified under these guidelines will be queried.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 18 of 20 References  
 
1. Law N0 47/2012 of 14/01/2013 relat es to the regulation and inspection of food and 
pharmaceutical products.  
 
2. Ministerial instructions No 20/12 of 18/02/06 determine the guideline for donated 
drugs in Rwanda.  
 
3. The regulation governing control of importation and exportation of pharmaceuticals 
and devices.  
 
4. Guidelines for Importation and Exportation of Medical Devices Including In Vitro 
Diagno stics and Laboratory Equipment, Second Edition, April 2020. Tanzania 
Medicines and Medical Devices Authority.  
 
5. International Electro -techni cal Commission, IEC 60601 -1 Edition 3.1 2012 -08 
 
6. Stringent Regulatory Authority : https://www.who.int/initiatives/who -listed -authority -
reg-authorities/SRAs#  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 19 of 20 ENDORSEMENT OF THE GUIDELINES  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices  
Doc. No.: FDSIM/FDIEC/GDL/001  Revision Date:17/10/2022  Review Due Date: 29/11/2025  
Revision No.: 1  Approval date:  24/11/2022   Effective Date: 30/11/2022  
Page 20 of 20  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEXES   
P.O. Box 1948  Kigali  
info@rwandafda.gov.rw  
www.rwandafda.gov.rw  
Format: DIS/FMT/125  
Revision No: 1  
Effective Date: 01 Nov. 2021  
 
 
 
 
  Ref. No:  DIS/……../FDA/2021  
 
 
 EXPORT  LICENSE OF PRODUCT CATEGORY.  
     
Reference made to your request No ……./2021 dated  D/M/2021 , EXPORTER NAME  based   in  KIGALI CITY , 
is hereby authorized to export PRODUCT CATEGORY , NOT containing narcotic and psychotropic substances, 
to CONSIGNEE . 
  
In accordance with export license requirements of pharmaceutical products, medical equipment, devices  and 
consumables, food products  and other products regul ated by Rwanda FDA, the exported  products are detailed 
below:  
  
Product Name  Quantity  BATCH NO Manufacture Date  Expiration Date  
 
 
 
 
     
This license is valid for three (3) months only.  
 
AGREEMENT  FOR REMOVAL  
 
Port of exit  is □MAGERWA   
 
Done at Kigali on ……………  
 
By Authority Delegation  
 
 
 
 
 
 
………………………  
Deputy Director General   
P.O. Box 1948  Kigali  
info@rwandafda.gov.rw  
www.rwandafda.gov.rw  
Format: DIS/FMT/1 22 
Revision No: 1  
Effective Date: 01 Nov. 2021  
 
  Ref. No:  DIS/……../FDA/2021  
 
 
 IMPORT LICENSE OF PRODUCT CATEGORY.  
     
Reference made to your request No ……./2021  dated  DAY/MONTH/2021 , IMPORTER NAME  based in 
KIGALI CITY , is hereby authorized to import into RWANDA,  PRODUCT CATEGORY  , NOT containing 
narcotic and psychotropic substances, from SUPPLIER NAME . 
  
In accordance with import license requirements of pharmaceutical products, medical equipment, devices and 
consumables, food products  and other products regulated by Rwanda FDA, the imported products are detailed 
on the invoice mentioned below:  
  
Invoice No  Date  Amount in 
USD  Chargeable 
amount/ USD  Chargeable 
amount/RWF  Supplier  Country of 
Origin  
     
  
Total     
This license is valid for three (3) months only. Exchange rate used:  970.089998  RWF  
 
AGREEMENT FOR REMOVAL  
 
Port of entry is □ MAGERWA   
 
Done at Kigali on ……………  
 
By Authority Delegation  
 
 
 
 
 
 
………………….. 
Deputy Director General   
P.O. Box 1948  Kigali  
info@rwandafda.gov.rw  
www.rwandafda.gov.rw  
Format: DIS/FMT/119  
Revision No: 1  
Effective Date: 27 Oct. 2021  
OFFICIAL CERTIFICATE OF IMPOR TATION OF CONTROLLED SUBSTANCES No:   …… /2021  
 
Adopted from the Single Convention on Narcotic Drugs, 1961 and Convention on Psychotropic Substances 1971  
 
Reference made to the Law Nº 003/2018 of 09/02/2018 establishing Rwanda  Food and Drugs Authority and 
determining its mission, organisation and functioning especially in its article 8,  Rwanda FDA is responsible for 
the implementation of laws and regulations  relating to narcotic drugs and psychotropic substances covered by 
international conventions and protocols, hereby authorizes the importation of controlled substance (s) listed below:  
 
SNo Brand name of 
the substances  International 
Nonproprietary 
Name  Pharmaceutical 
dosage form  Quantity  Content per 
unit in (mg)  Total 
quantity in 
grams (g) 
1       
2       
 
Details of Importer (Name, Location, Tel, Fax, 
Postal Address, E -mail.)  Details of Exporter (Name, Location, Tel, Fax, 
Postal Address, E -mail.)  
  
Shipping information/Method:  Name of the Port of entry in Rwanda:   
Reasons of import (Medical or scientific research, registration purposes):  
Reference Proforma/ Invoice No:                                             Date :  
 
  This certificate is subjected to the following conditions : 
1. This certificate is valid for one (1) shipment only.  
2. This certificate is only valid for substances or preparations as specified above.  
3. This certificate is valid for importer and exporter as specified above.  
4. It is not  permitted to import quantities greater than those specified in this certificate.  
 
  Validity: This certif icate is valid only for twelve (12 ) months from date of its signature  
  Done at Kigali, on ………………….  
  By Authority Delegation   
 
 
………………………………………….  
Deputy Director General    
P.O. Box 1948  Kigali  
info@rwandafda.gov.rw  
www.rwandafda.gov.rw  
Format: DIS/FOM/151  
Revision No: 1  
Effective Date: 01 Nov. 2021  
 
RELEASE UNDER  SEAL FORM  
 
I, …………………………………………………, inspector of food, drugs and other regulated products in 
Rwanda food and drugs authority ( RWANDA FDA ) at ………………… …Port of entry, hereby RELEASE 
UNDER  SEAL  this/these consignment(s) after physical inspection and/or other regulatory documentation 
requirements.  
 
Details of the consignment:  
 
S/N Importer Name  Import 
License No Country of 
origin  Invoice No RRA 
Declaration  No/ 
if applicable  Product 
Category  
1  
      
2  
      
3  
      
 
Reason of Underseal Release: 
…………………………….................................................................................................................. ......................
............................................................................................................. ......................................................  
Place of inspection: …………………………………………………………………………………………...  
 
Proposed da te of inspection: …….…/…………/…. .  
 
Note: This consignment/ product should be used or sold after the final release by Rwanda FDA. The 
Importer is recommended to Notify/confirm the date of final Inspection one day before.  
 
Rwanda FDA Inspector (s)   
(Name, phone, Date and Signature)  For the Importer/Representative  
( Name, phone, Date and  Signature )  
  
 
 
 
  
  
 Department/Division/Office/Unit   FDISM/PVSM  
Document Type:  Form  Doc. No  : FDISM/PVSM /FOM/ 016 
 Title:  
SUSPECTED POOR QUALITYPRODUCT REPORTING 
FORM   Revision Number  : 2 
Revision Date:  :  05/08/2022  
Effective Date  : 12/08/2022  
Review Due Date  : 05/08/2025  
Ref Doc.  :FDISM/PVSM/GDL/003  
 
I. PRODUCT CATEGORY (Tick as appropriate)  
Medicinal product Vaccine  Other Biological Products Herbal product Other (Please Specify):  
…………………………………………………………………………………………………………………………………………  
II. PRODUCT DETAILS  
Brand 
name   Generic Name   
Batch/Lot 
No  Manufacturin
g Date   Expiry 
date  Date of 
receipt   
Name of manufacturer   Physical Address and 
Country of Origin   
Name of Distributor/Supplier   Distributor/ Supplier’s 
Address   
III. PRODUCT FORMULATION  IV. DESCRIPTION OF PRODUCT COMPLAINT  
 Tablets /capsules  
 Suspension/Syrup  
 Injectable/Infusions  
 Creams/Ointment/Liniment/Paste  
 Pessaries  
 Suppository  
 Powder for reconstitution of oral suspension  
 Powder for reconstitution of injection  
 Ear/Eye drops  
Diluents  
Nebulizing solutions  
Other  (Please Specify) …………………………………….  
 Color/odor change  
Molding  
Turbidity  
Mislabelling  
Poor Packaging/ lack of patient leaflet/ lack measuring devices  
Therapeutic ineffectiveness  
Particulate matter  
Seal Integrity of packs and/ or Leakage  
Caking  
Separating  
 Incomplete packs  
Powdering/crumbling  
 Suspected falsified/ Substandard  
Others Specify)  …………………………………………  
Describe the Complaint in details:  
………………………………………………………………………………………………………………………………………………………………
……………………………………………………………………………… …………………………  
 
V. PRODUCT STORAGE CONDITIONS  
Does product require refrigeration?                                         YES NO  
Does product require protection from light?                          YES NO  
Does product require protection from Moisture?                   YES NO  
Was it stored following manufacturer/Rwanda FDA guidelines? YES  NO  Other Storage details  (if necessary):  
 
 
VI. CIRCUMSTANCE AND TIME OF THE POOR -QUALITY DETECTION  VII. ACTION TAKEN  
When did you notice the poor -quality problem?  
Before taking/administering the product  
While taking/administering the product  
After taking/administering the product  
When the patient returned the product   
After a complaint of the patient  
After Visual inspection  
After quality control  
Other(specify)……………………….   
 Stop Taking/Administration of the product  
Quarantining the product  
 Returning the product to the supplier  
Other (specify):…………………….  
 
Have you experienced any adverse event after taking this medicine? YES   NO If YES, please complete the ADR/AEFI Reporting Form.  
 
VIII. REPORTER INFORMATION   
Name of reporter:   
 Qualification:   Phone number:   
Name of Health 
Facility   District:    Report Reference No:   
E-mail Address:   Contact/Tel 
No:  Date of report:   
All information is held in strict confidentiality and will not disclose reporter’s identity in response to any public request . Information supplied will 
contribute to the improvement of safety and vigilance of Medical Products in Rwanda. Once this form is completed please send it to Rwanda FDA 
via the following email: pv_sm@rwandafda.gov.rw