Rwanda - Register Medical Devices

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Procedure

Apply In-Person

1. Visit the bank to pay the registration fee according to the class of the device and the type of company you are registering for i.e. domestic or foreign company and obtain the payment receipt
2. Visit the Rwanda Food and Drugs Authority (FDA) office to obtain the application form for registration or download directly via this link: FDA and fill it correctly
3. Write an application letter addressed to the FDA requesting registration of the device/s
4. Prepare the required documents for registration as explained in the” Required Documents” section below and attach them in a single file
5. Visit the Rwanda FDA office, Pharmacovigilance and Food Safety Monitoring unit to submit your complete application to the officer located at the reception
6. The officer will verify the application and forward it to the responsible authority for assessment and approval
7. The FDA may deem it necessary to conduct an inspection to verify the information you have provided in your application. In this case you will be called and notified of the inspection date
8. On the inspection date, the FDA will send an inspection officer to conduct inspection pertaining to your application and submit the findings to the FDA for assessment and decision making. Note that the inspection will be based on-site inspection and causal inspection of the non-clinical studies, clinical trials, bio-studies and production site for the inspection to confirm the authenticity, precision and integrity of information and data submitted.
9. The FDA will assess the application and the inspection results and if it meets the required standards, they will approve the application and prepare the certificate of registration
10. A scanned copy of the certificate will be sent to you through your email address and you will need to go to the FDA office to obtain the original certificate.
    
    

NOTE:

1. If the applicant is a foreign company, they shall appoint and submit the application through a local technical representative registered as a wholesale company or an accredited manufacturer's representative. All applications and supporting documents shall be in English.
2. You can also submit your application via email through this address: [email protected]

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Required Documents

• Payment receipt
• Application letter, dated and signed by company representative
• Application form - med registration, dated and signed by company representative
• CD ROM with summary of technical documentation (STED) (2 original ) or external hard drive; any document in any language other than English must be accompanied by a certified or notarized English translation; document format allowed are: PDF, QOS, QIS, MS-Word; PDF documents should be in OCR (Optical Character Recognition), selectable and searchable
• Medical device commercial sample (2 original) additional samples may be required
• Certificate of analysis (laboratory analysis results) (original)where applicable

Office Locations & Contacts

RWANDA FOOD AND DRUGS AUTHORITY
KK 15 St, Kigali
Tel: +250 788 890 738
Email: [email protected]
Website: Rwanda Food and drugs Authority

Eligibility

• Foreign and domestic company intending to manufacture, import or export a medical device

Fees

• Domestic medical devices RWF 100,000 Class A or RWF 120,000 Class B or RWF 200,000 Class C or RWF 220,000 Class D
• Foreign medical devices USD 500 Class A or USD 1,000 Class B or USD 150 Class C or USD 200 Class D
• Payment methods: cash,credit cards, check Payment can be made on any of the following bank accounts in RWF or USD:

• National Bank of Rwanda (RWF):1000047658 - Rwanda FDA
• National Bank of Rwanda (USD):1000047666 - Rwanda FDA
• Bank of Kigali (RWF):00040 06972093 63 - Rwanda Food and Drugs Authority
• Bank of Kigali (USD): 00040 06972094 64 - Rwanda Food and Drugs Authority

Validity

• A certificate of registration is valid for a period of 5 years from the date of issuance and may thereafter be renewed. The renewal shall be made at least 3 months before the expiry of existing registration.

Documents to Use

• Application form

Sample Documents

• Registration certificate

Processing Time

• 18 to 26 days

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• A separate application must be submitted for each medical device if you have multiple devices you wish to register

Required Information

• Names
• Product details
• Company details
• Addresses
• Declaration
• Signature
• Stumps

Need for the Document

• You must register your medical devise and obtain the registration certificate if you wish to manufacture, import or export a medical device as per required by law

Information which might help

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Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• Trade Portal

Others

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