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Medical professionals dealing with medical devices, food supplements, cosmetics, Non Profit Organizations and development partners products are required to register and obtain credentials to access Pharmacy and Poisons Board's (PPB) online service portal.
A medical device is an instrument, apparatus, implement, machine, applicane, In Vitro Diagnostics (IVD), implant, reagent for into use, software, material or other similar or related article intended by the manufacturer to be used alone in combination for human beings for one or more of the specific medical purpose (s) of:
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
Investigation, replacement, modification or support of the anatomy or of a physiological process
Supporting or sustaining life
Control of conception
Disinfection of medical devices
Providing information by means of in vitro examination of specimens derived for the human body and does not achieve its primary intended action by pharmacological immunological or metabolic means in or by the human body, but which may be assisted in its intended function by such means.
Registration of medical devices is regulated by Pharmacy and Poisons Board. who issues a medical device registration certificate. The certificate is valid for five (5) years from the date of issue, and traders are advised to apply for renewals at least ninety (90) days before the expiry date.
All importers are required to obtain an import declaration form (IDF) for each consignment prior to importation of any commodity. Import declaration forms are processed through the Kenya National TradeNet System (KESWS). Applications can either be made by the importer or the clearing agent appointed by the importer.
Before applying for the IDF, traders are advised to obtain permits/get a go ahead from the respective regulating Agencies for the consignment of import. Also, application for the IDF should be done before goods leave the country of origin.
Import of medical devices is regulated by Pharmacy and Poisons Board (PPB) who issue product registration certificates for all new products, licences & certificates, and import permits per consignment. For more information on how to import your consignment of medical devices through Jomo Kenyatta International Airport (JKIA), click on the link.
Full procedure view - for a first time trader
Medical devices import procedure through Port of MombasaThis procedure sequentially compiles the licences, permits and clearance steps to be fulfilled by a registered business owner importing a consignment of medical devices, of more than $2000 of value, through the Port of Mombasa.