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Medical devices (Vifaa vya matibabu) See associated HS codes

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Import

Preliminary registrations, licences & certificates

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.

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Medical device listing

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.

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Train & register with Kenya TradeNet System (KESWS)

The Kenya National TradeNet System (KESWS) is an electronic platform that facilitates the processing and issuance of permits, import declaration forms (IDF) and declaration of goods. Traders are required to register with Kenya Trade Network Agency (KENTRADE) as either exporters or importers and get trained on how to lodge documents on KESWS. The traders are then issued with user credentials which enable them to login and access the System.

For more information on how to train and register with KESWS, please select from the options below.

Permits

Import permit for medical devices

Importation of new medical devices requires an importer to obtain a medical device registration certificate from Pharmacy and Poisons Board (PPB) who also issues an import permit for medical devices for each consignment. The import permits are processed through the Trade Facilitation Platform (TFP ), per consignment.

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Import declaration form (IDF)

All importers are required to obtain an import declaration form (IDF) for each consignment prior to importation of any commodity. 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.

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Local certificate of compliance (COC)

A certificate of compliance is a certified document by Kenya Bureau of Standards (KEBS), which assures that commodities have met required standards and specifications. When a consignment arrives in Kenya without a certificate of conformity, indicating that the consignment was inspected at the country of origin, an importer will have to obtain a certificate of compliance. The certificate is only issued after successful inspection and verification of the consignment is carried out by KEBS.

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Import standardization mark (ISM)

The Import Standardization Mark (ISM) is a mandatory requirement for all imported products intended for sale in the local market. The Kenya Bureau of Standards (KEBS) is the competent authority that regulates issuance of the ISM stickers. Traders are advised to apply for the ISM sticker once the goods have arrived, and the customs entry has been verified and passed by Kenya Revenue Authority (KRA).

The following products are exempted from the ISM sticker; medicines, medical devices, pest control products, seeds (plant materials), printed materials, for example, books, newspaper, magazines etc., precious stones, jewellery etc., illuminated signs and name plates etc., motor vehicles and bike (covered under a different inspection regime), artificial flowers, walking sticks, antiques etc.,products manufactured in an EAC Partner State and bears quality mark of that partner state.

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Import declaration form (IDF)

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Certificate of radioanalysis (Port of Mombasa) (for imports)

The Kenya Nuclear Regulatory Authority (KENRA) is the Authority that regulates all radioactive materials, materials that contain radioactive elements and equipment that produce radioactive waves in Kenya. As the regulator, KENRA issues the certificate of radio analysis to ascertain that commodities are free of radioactive elements. The certificate is processed through the Trade Facilitation Platform (TFP). For more information on how to obtain the certificate, click on the link.

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Clearance

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Procedures for a first-time trader

Medical devices import procedure through Port of Mombasa

This 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.

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