Kenya: new regulation on the import of medical devices and other products

kenya 212x116.pngPer esportare in Kenya prodotti quali dispositivi medici, integratori alimentari, cosmetici medici, prodotti a base di erbe e similari sarà necessario ottenere il Pre-Export Certificate of Conformity.

 

The importers of Medical Devices, Food Supplements, Medical Cosmetics, Herbal Products and other Allied Healthcare Borderline Products are required to obtain a Certificates of Conformity (CoC) for their cargo.

 

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ITA (ENG below)

 

Dal 1 settembre 2017 per esportare in Kenya prodotti quali dispositivi medici, integratori alimentari, cosmetici medici, prodotti a base di erbe e similari, sarà necessario ottenere il Pre-Export Certification of Conformity rilasciato dal Kenya Bureau of Standards. 

 

Tutti gli importatori di tali prodotti possono scaricare le "Guidelines on Inspection of Imported Medical Devices, Food Supplements, Medical Cosmetics, Herbal Products and Other Borderline Products" sul sito www.pharmacyboardkenya.org.

 

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ENG

 

Kenya Bureau of Standards (KEBS) is a statutory body established under the Standards Act, CAP 496 Laws of Kenya mandated to offer, among other services, quality inspection of imports based on Kenya Standards or approved specifications.

 

The Pharmacy and Poisons Board (PPB) is the National Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244, the Laws of Kenya. PPB is mandated to regulate the Practice of Pharmacy and the Trade in Drugs, Poisons, Medical Products and Health Technologies.

 

In an effort to protect the public against imported products that do not comply with local quality standards and technical regulations, ALL Imported Medical Devices, Food Supplements, Medical Cosmetics, Herbal Products and Other Allied Healthcare Borderline Products falling under the regulated mandate of Pharmacy and Poisons Board MUST comply with Pre-Export Verification of Conformity (PVoC) to Standards programme implemented by KEBS.

 

The importers of Medical Devices, Food Supplements, Medical Cosmetics, Herbal Products and other Allied Healthcare Borderline Products are therefore required to obtain Certificates of Conformity (CoC) for their cargo before applying for Import Permits from Pharmacy and Poisons Board through the Kenya National Single Window Electronic (Kentrade) System.

 

All importers of the above commodities are requested to download the Guidelines on Inspection of Imported Medical Devices, Food Supplements, Medical Cosmetics, Herbal Products and Other Borderline Products from www.pharmacyboardkenya.org or www.kebs.org for further guidance.

 

Enquiries on the PVoC requirements on Imported Medical Devices, Food Supplements, Medical Cosmetics, Herbal Products and other Allied Healthcare Borderline Products should be addressed through; Pharmacy and Poisons Board: tradeaffairs@pharmacyboardkenya.org

 

Note:

 

1. Pharmaceutical Manufacturers licenced by the Pharmacy and Poisons Board importing Raw Materials, Machinery and Spares for own use are exempted from the above requirements as outlined in PVoC manual available on KEBS website (www.kebs.org). Licenced Pharmaceutical Manufacturers are encouraged to obtain PVoC Exemption Certificate from KEBS in order to facilitate clearance of their cargo.

 

2. All imported goods referred to, in this public notice arriving at the port of entry without a CoC as from 1st September 2017 will be subjected to destination inspection by KEBS after payment of destination inspection fees as provided for under Legal Notice No. 78.

28/06/2017