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Import

Medical devices (Vifaa vya matibabu) See associated HS codes

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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 on the Trade Facilitation Platform (TFP)

The Trade Facilitation Platform (TFP) is an electronic system that facilitates the online application, processing, approvals and issuance of export and import permits, and declaration of goods. Traders are required to be trained and then registered on the TFP as users of the system. The TFP is managed by the Kenya Trade Network Agency (KenTrade). For more information on how to train and register on the TFP, 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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Import licence for radioactive devices

The Kenya Nuclear Regulatory Authority (KNRA) is mandated to provide protection of persons, property and the environment against the harmful effects of ionizing and non-ionizing radiation through the establishment of a system of regulatory control. Prior to importation of radioactive devices and/or sources, importers must obtain an import licence from KNRA. For more information on how to obtain the licence, click the link.

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Local certificate of conformity (COC)

A certificate of compliance is a certified document issued by the Kenya Bureau of Standards (KEBS), which assures that commodities have met the 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 the 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 East African Community (EAC) Partner State, and bears a quality mark of that partner state.

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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 the relevant 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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Certificate of radioanalysis

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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