Rwanda Medical Device Regulation

Understanding Medical Device Registration in Rwanda

Updated On: 24/01/2024

Regulatory Authority: Rwanda FDA

Rwanda Food and Drugs Authority hereafter designated as the “Authority,” was established by the law No 003/2018 of 09/02/2018 determining its mission, organization, and functioning. The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco, and tobacco products.

The conduct and performance of the Authority is underpinned by the following five core values:

• serving with Professionalism for excellent service delivery
• continuously work with Integrity
• promoting Accountability at all times
• nurturing Teamwork to achieve common objectives
• striving for Innovation to create value for our stakeholder and other interested parties

Link for Regulatory Authority: https://rwandafda.gov.rw/

Local Regulation:

• Technical regulations No CBD/TRG/012
• Regulations Governing Registration of Medical Devices including In Vitro Diagnostics Rev_2
• Guidelines for Registration of Medical Devices

Classification:

• • Class A
  • Class B
  • Class C
  • Class D

Listing or Registration Requirements:

An application consists of online or hard copies submission. The application for registration of medical devices is only received by the Authority when the payment of prescribed registration fees is affected. After receiving a product registration application, a reference number is assigned to the application, and it will be used in all subsequent correspondences relating to the application. An acknowledged receipt will be issued.

Documents Required for Registration:

• An application for medical devices registration in Rwanda shall include the following:

1. Signed and dated original hard copy of cover letter
2. Signed and dated application form for device registration
3. Proof of payment of registration fee at the time of submission
4. Two CD-ROM or any other external driver containing STED in a selectable PDF.
5. Two commercial samples of medical devices and certificate of conformity (where applicable), however additional samples might be required.

• For medical devices where the STED is prepared on request, the manufacturer should be able to assemble and submit it in the timeframeindicated by such notification as may be given by the Authority.
• The manufacturer should submit the STED in the prescribed format.
• A copy of any submitted information to the Authority should be held by the manufacturer for future reference.

Registration Timeline:

Medical device dossiers shall be scheduled for assessment according to the First in First out (FIFO) basis upon compliance of the requirements. A new application shall be processed within nine (9) months of receipt of the application. The applicant will be required to provide any requested additional data within ninety (90) calendar days. Additional data or query responses shall be processed within sixty (60) calendar days.

License Validity: 5 years

Special Labelling Requirements:Labelling should be done in English.

Requirements to import medical devices: Import License

• Import VISA: It is a permit issued after verifying whether products to be imported comply withapplicable legal and regulatory requirements (standards) for quality, safety, and effectiveness.
• Commercial invoice
• Certificate of analysis (CoA) of imported products. A CoA is an official document that meant to testify quality control data for a particular lot/batch of product. A CoA can be replaced by Health Certificate or Phytosanitary Certificate. (Other alternatives are detailed below in Notes No 1,2 &3).

https://rwandafda.gov.rw/wp-content/uploads/2023/01/ee_Summary%20Requirements%20for%20authorization%20to%20import%20regulated%20products_R%20FDA.pdf

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]