The Standardization Mark (S Mark) is a mandatory mark of quality required for goods that are processed and packaged locally intended for local consumption or for export within the East African Community (EAC) region. Traders wishing to export processed goods within the EAC region are therefore required to obtain an S Mark permit which is issued by the Kenya Bureau of Standards (KEBS). The permit is valid for one (1) calendar year from the date of issue.
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:
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.
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. Training is mandatory for new users of the system prior to registration on the system; this includes new staff from organisations already registered on the system. The TFP is managed by the Kenya Trade Network Agency (KenTrade). For more information on how to register with TFP, click the link.
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.
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.