• Medical devices including In vitro diagnostics constitute a vital component of health products and health technologies that contribute to the attainment of the highest standards of health for all citizens as envisioned in Article 43 of the Constitution of Kenya.
• The Health Act 2017 and Health Products and Technologies (Medical Devices including IVD Medical Devices) Regulations (Gazette Notice 35 2014) requires evaluation and registration of medical devices, including In-Vitro Medical Devices, prior marketing in Kenya.
• Applications are filed at the Pharmacy and Poisons Board is the Drug Regulatory Authority - Register at the ministry of Health in Kenya.
  

Apply In-Person

1. Registering for a medical Device is a complicated process and most companies find it beneficial to engage a local agent to take care of the bureaucratic procedures and any communication issues.
2. Approach the Pharmacy and Poisons Board offices and acquire an application form which you have to fill and submit.
3. Fill up the application form provided at the Pharmacy and Poisons Board offices and submit the filled up required document together with all required documents. This are mentioned at the “Required Documents” section of this page...
4. Make sure you also pay the appropriate fees as advised by the board’s officers.
5. Once your application is approved you will received a Certificate evidencing registration of the medical device.
6. An applicant for a manufacturer outside Kenya must file evidence of Power of Attorney from the manufacture which authorizes him to speak for his principal on all matters relating to the application. The original Power of Attorney is to be notarized in the country of origin by a Notary Public and submitted to PPB Or Contract Manufacturing Agreement (where applicable).
7. This should be notarized in the country of origin by a Notary Public and submitted to Pharmacy and Poisons Board is the Drug Regulatory Authority (PPB).
8. The application process usually takes a period of three months.

1. CFS (Certificate of Free Sale.)
2. Quality system certification (for sterile products)
3. Declaration of conformity certificate
4. Description of device and intended medical use
5. Clinical and preclinical data, test reports, and other data to support the safety and efficacy of the device, as required by the law in Kenya.

Pharmacy & Poisons Board (PPB) - Head Office
P.O. Box 27663 – 00506, Nairobi.
Address: Lenana Road Opp. DOD
Reception: +254 709 770 100
General Enquiries +254 709 770 100
General Enquiries:enquiries@pharmacyboardkenya.org
Pharmacy Questions:info@pharmacyboardkenya.org
Report a Medicine Problem:pv@pharmacyboardkenya.org
About this website:webmaster@pharmacyboardkenya.org
Pharmacy and Poisons Board Contacts
Pharmacy and Poisons Board Website

To be able to register for medical device you must be:

1. A manufacturer of medical device in Kenya.
2. If you manufacturer outside Kenya you must appoint an authorized Representative.

Explain the fees structure which is required for obtaining the certificate/document.

• Valid for 1 year

Please attach documents that can be used by people. e.g. links

Please attach sample completed documents that would help other people.

• Three months

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Premarket Approval Process

1. It is recommended that applicant appoints a local representative.
2. Fill out application form and submit all required documents (listed below).
3. If approved, applicant will receive a registration certificate

• There is Post market Surveillance set up in place.
• This include: Sampling, monitoring, and vigilance controls in place.

1. Administrative information.
2. Manufacturer name and address.
3. Local Authorized Representative and Subcontractors.
4. Local Authorized Representative.
5. Device identification.
6. Device classification.
7. Related previous submissions.
8. Accessories.
9. Device description.
10. Intended use.
11. Market history.
12. Sales, complaints and vigilance.
13. Draft Declaration of Conformity
14. Essential Principles Checklist
15. Manufacturing process and subcontractors
16. User information
17. Design verification and validation
18. Risk management
19. Clinical evaluation
20. Biological safety
21. Sterilization validation
22. Shelf Life Validation should include
23. Sterilization Validation – Radiation should include
24. Software
25. Packaging
26. Shelf life and stability testing
27. Product lifetime
28. Animal derived substances
29. Grouping Requirements for Product Registration

Please provide the need for the procedure. e.g. Birth Certificate - why do we need to have a birth certificate? 
 

International Classification: Examples A Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale B Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask C Blood glucose self-testing, ECG, X-ray Unit, Syringe, Condom, Contact lens D HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker

• view medical devises

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

• GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES
• [GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES INCLUDING IN-VITRO-DIAGNOSTICS (IVD’s)]
• Heath act 2017

1. All medical devices are regulated by the Drug Policy and Planning Center (DPPC) and the Central Administration of Pharmaceutical Affairs (CAPA).
2. Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or 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 from the human body;
   • disinfection substances,
   • aids for persons with disabilities,
   • devices incorporating animal and/or human tissues,
   • Devices for in-vitro fertilization or assisted reproduction technologies.

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.