In Kenya, medical equipment must meet the following certification and standard requirements to ensure safety and quality in healthcare delivery.

1. Kenya Bureau of Standards (KEBS) Certification:
 The KEBS is the national standards body of Kenya and is responsible for developing and implementing standards for various products, including medical equipment. The KEBS certification is mandatory for certain medical equipment, such as diagnostic imaging equipment, to ensure their safety and compliance with the relevant Kenyan standards.

2. Pharmacy and Poisons Board (PPB) Approval:
 The PPB is responsible for regulating the importation, exportation, manufacture, and sale of drugs, food, cosmetics, and medical devices in Kenya. Its approval is mandatory for all medical equipment in Kenya, including imported and locally manufactured equipment.

3. International Standards:
 The International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO) develop international standards for various medical equipment. These standards ensure that the equipment is safe, reliable, and of good quality.

4. CE Marking:
 The CE Marking is a certification mark that indicates compliance with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). Medical equipment with the CE Marking is considered to comply with the relevant European standards and can be marketed in Kenya.

Registration Process:

• ● Fill up the application form and submit the filled-up required document together with all required documents.
  ● Pay the appropriate fees as advised by the board’s officers.
  ● Once your application is approved you will receive a Certificate evidencing the registration of the medical device.
  ● An applicant for a manufacturer outside Kenya must file evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal on all matters relating to the application. The application process usually takes a period of three months.
• Classification:
   Class A,B,C,D

Documents Required:
● Common Submission Dossier Template (CSDT)
● Letter of Authorization for Authorized Representative
● Device Labelling
● Pre-verification certificate for Notified Body
● IFU, Patient information leaflet, promotional material
● Certificate of Analysis
● Information on sterilization methods and validation standard
● Regulatory Approval from the country of origin
● QMS certificate
Additional for Class B, C and D
● Essential Principles Checklist
● Design verification and validation
● Risk Analysis
● Clinical Evidence

Standards
 ISO 13485, ISO 14971, and IEC 60601.

Registration Timeline:
 Around 9-12 months

License Validity:
 5 years

Import Value
Key information about Kenya Imports: Medicinal and Pharmaceutical Product
● Kenya Imports: Medicinal and Pharmaceutical Product was reported at 195,063.899 USD th in Dec 2021
● This records an increase from the previous number of 127,959.759 USD th for Dec 2020
● Kenya Imports: Medicinal and Pharmaceutical Product data is updated yearly, averaging 57,329.693 USD th from Dec 1995 to 2021, with 27 observations
● The data reached an all-time high of 195,063.899 USD th in 2021 and a record low of 16,843.881 USD th in 2000
● Kenya Imports: Medicinal and Pharmaceutical Product data remains active status in CEIC and is reported by United Nations Conference on Trade and Development
● The data is categorized under World Trend Plus’s Association: Pharmaceutical and Biotechnology Sector – Table RT.UNCTAD.MPP:
Medicinal and Pharmaceutical Product: Imports Value by Individual Economies and Territories

Top Importers
– Prodigy Pharmaceuticals Limited
– Philips East Africa Limited
– Coptic hospital
– AllMed Medical Supplies Limited
– SurgiPharm Limited

Competitors
1. Megascope Healthcare Ltd
 Megascope Healthcare is widely recognised as the most reliable supplier of quality medical equipment in Kenya, offering a wide selection of quality and affordable medical equipment.
Contact: +254 722 299 097
Email: info@megascopekenya.com

2. Phoenix Equipment Ltd
 The company is registered in Kenya as a supplier of medical equipment and solutions for the hospital field and homecare use with efficient distribution channels to supply efficiently across Eastern Africa.
Location: Visions Plaza, Mombasa Road, Nairobi
Contact: 0728 853 905
Email: info@phoenixequipltd.com

3. Toda Medical Supplies
 Toda Ltd is regionally recognised as distributors of medical equipment and devices for Intervention radiology, ENT, neurosurgery, cardiovascular, urology and general surgery.
Contacts: +254 723 086 338, +254 20 528 9177
Email: info@todamedicalsupplies.co.ke

4. Barfield Hospital Supplies Ltd
 It supplies medical equipment & surgical instruments. It also manufactures custom-designed and standard hospital furniture.
Contact: +254 020 248 5585/ 020 2699104
Email: info@barfieldltd.com

5. Nairobi X-ray supplies Ltd
 It is mainly involved in radiological, surgical, dialysis, hearing implants and endoscopy supplies of quality equipment from Japan.
Contact: +254 733 512 802, +254 703 700 766
Email: info@nxsltd.com

6. Medmax Ltd
 Medmax is a leading supplier of diagnostic products, hospital furniture, walking aids and laboratory equipment.
Location: Industrial Area, Nairobi
Contact: +254 733 589 509/ +254 705 071 699

7. Angelica Medical Supplies Ltd
Location: 1st floor, Regent Court, Hurlingham, Nairobi
Contact: +254 020 265 4721
Email: info@angelicamedical.com

8. Bioscope Laboratory Supplies Ltd
 The company supplies laboratory chemicals, consumables and equipment across the East African region.
Location: Nabro Towers, Ngara, Nairobi
Contact: 0720 537 146
Email: sales@bioscope.co.ke

9. Promech Enterprise Limited
Location: Green House Building, Along Ngong Road
Contacts: +254 723 540 960
Email: info@promechkenya.com

10. Omsai Distributors Limited
 The company supplies medical devices and equipment to private, public and non-governmental institutions in Kenya. It supplies equipment such as hospital beds, pediatric beds, medical carts, delivery beds and blood transfusion sets.
Contacts: +254 784 705 606, +254 705 705 606