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Import

Medical devices (Vifaa vya matibabu) See associated HS codes

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Preliminary registrations, licences & certificates

The Pharmacy & Poisons Board (PPB) is the drug regulatory authority that regulates the practice of pharmacy, and the manufacture & trade in drugs and poisons. PPB aims to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy & quality for all drugs, chemical substances & medical devices, locally manufactured, imported, exported, distributed, sold, or used, to ensure the protection of the consumer as envisaged by the laws regulating drugs in force in Kenya. Import of licit drugs is regulated by PPB. Registration and application for licences is done on the PPB online service portal. For more information on how to register on the PPB online service portal, click the link.

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Medical device registration certificate

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 (1) or more of the specific medical purposes:

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 the Pharmacy & Poisons Board (PPB) who issue a medical device registration certificate. The certificate is valid for five (5) years from the date of issue. Importers are advised to apply for renewals at least ninety (90) days before the expiry date. For more information on how to obtain a medical device registration certificate, click the link.

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The Kenya Trade Network Agency (KenTrade) is a State Corporation mandated to establish, implement & manage the Trade Facilitation Platform (TFP), and to facilitate trade. The TFP is an online platform that serves as a single entry point for parties involved in international trade & transport logistics to lodge documents electronically, for processing, approvals and to make payments electronically for fees, levies, duties & taxes due to the Government, on imported or exported goods. Training is mandatory for new users of the system prior to registration on the system; this includes new staff from organizations already registered on the TFP. For more information on how to register on the TFP, click the link.

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Permits

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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Certificate of radioanalysis

The Kenya Nuclear Regulatory Authority (KNRA) is a public entity established to provide radiation protection, nuclear safety, nuclear security, nuclear safeguards, and the protection of persons, property and the environment against the harmful effects of ionizing & non-ionizing radiation through the establishment of a system of regulatory control. For more information on how to obtain a certificate of radioanalysis for consignments imported through the Jomo Kenyatta International Airport (JKIA), the Inland Container Depot, Nairobi (ICDN), or the Port of Mombasa, select from the options below.

Import Declaration Form (IDF)

The Import Declaration Form (IDF) is a declaration of the customs value of a consignment, and is issued by the Kenya Revenue Authority’s (KRA), Customs Services Department. Importers are required to complete an IDF and sign it to show that they have declared the true & accurate value of the imported goods before they leave the country of origin. IDFs that remain unutilized after three (3) months from the date of issuance will automatically attract the appropriate sanctions. For more information on how to obtain an IDF, click the link.

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Medical device permit

Importation of new medical devices requires an importer to obtain a medical device registration certificate from the Pharmacy and Poisons Board (PPB), who also issue a medical device retention certificate for each consignment. The retention certificates are processed through the Trade Facilitation Platform (TFP ). For more information on how to obtain a medical device retention certificate, click the link.

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Local Certificate of Conformity (CoC) (only applies to consignments that arrive without a CoC)

A Certificate of Conformity (CoC) is a certified document issued by the Kenya Bureau of Standards (KEBS), which assures that commodities have met the required standards & specifications. When a consignment arrives in Kenya without a CoC, indicating that the consignment was inspected at the country of origin, an importer is required to obtain a local CoC. The certificate is only issued after successful inspection & verification of the consignment is carried out by KEBS. For more information on how to obtain a local CoC, click the link.

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Import Standardization Mark (ISM) permit (only applies to consignments for sale in the local market)

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 & bikes (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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Clearance

Please select exit/entry point

Medical devices import procedure through the Jomo Kenyatta International Airport (JKIA)

In accordance with the provisions of the East African Community Customs Management Act (EACCMA), goods for importation shall be entered (declared) within twenty-one (21) days after the commencement of discharge or in the case of vehicles, on arrival. Importers are required to acquire the services of a licensed customs clearing agent, who is mandated to process the importation documents in the Customs system and assist in clearing goods on the importer’s behalf. For more information on how to import a consignment of medical devices through JKIA, click the link.

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Medical devices import procedure through the Port of Mombasa

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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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