Timeframe ( ver detalles )

Espera hasta paso siguiente

5 mn - 15 mn

1 day - 7 days

Contact details

Entity in charge

Pharmaceutical Regulatory Information Management system

Tel: +250 788 890 738
Email: info@rwandafda.gov.rw
Website: https://misptf.moh.gov.rw/

Expected results

Application submitted confirmation email

Requirements

1.

Import visa - med

2.

Invoice - med (original)
showing: name and full address of supplier, international non proprietary name (INN), quantity to be imported for each health product, name and country of origin of manufacturer

or

Certificate of donation (original)
showing total value of donated products

3.

Packing list (original)
showing: imported quantities, serial number, manufacturing and expiring dates (if applicable)

4.

Certificate of conformity or quality control tests (original)
for each batch of medical equipment; issued by manufacturer

Time frame

Attention at counter: Min. 15mn - Max. 30mn

Waiting time until next step: Min. 1 day - Max. 7 days

Legal justification

1.

Law nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organisation and functioning
articles 3, 8, 9

2.

Law nº 47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products
Article 35

3.

Law N° 03/2012 of 15/02/2012 governing narcotic drugs, psychotropic substances and precursors in Rwanda
Article 13

4.

Regulations governing control of importation and exportation of pharmaceutical products and medical devices

5.

FDA Guidelines on requirements and specifications for masks

6.

FDA Guidelines on requirements and specifications for hand sanitisers

7.

FDA Notice to the public - 20 March 2020

Additional information

Applications can also be submitted per email: info@rwandafda.gov.rw. In this case, the import license will also be sent to the importer per email.
All supporting documents should be in English or French.
Consignment is inspected for compliance with claimed specifications and samples may be taken for quality control tests.
Substandard or non registered health commodities shall be re-exported or incinerated. The cost will be paid by the importer.

Recourse: Rwanda Food and Drugs Authority

Entity in charge

Rwanda Food and Drugs Authority

Nyarutarama Plaza - KG 9 Avenue, Kigali P.O Box 1948
Tel: 9707 / +250 789 193 529
Email: info@rwandafda.gov.rw
Website: https://www.rwandafda.gov.rw/web/
Directions: