Relevant Regulatory Harmonization Initiatives
Medical device regulation is based on:
-the Global Harmonization Task Force (GHTF) for Medical Devices
-European Union Directives (on Medical Device Directives 93/42/EEC, In VitroDiagnostic Device Directive (IVDD) 98/79/EC and Active Implantable Medical Device Directive (AIMDD) 90/385/EEC)
-The Pharmacy and Poisons Act Chapter 244 of 2002
-US FDA (United States Food & Drug Administration)
-Australia TGA (Therapeutics Goods Act)
-Pan African Harmonization Working Party on Medical Devices and Diagnostics
Common Technical Document (CTD) Acceptance
Clinical Trial Data Requirements
The Pharmacy and Poisons Board (PPB) requires a list of possible hazards, an evaluation of these risks against claimed benefits of the device, and a method for reducing risk. For pre-clinical and clinical studies, the applicant must supply details on biocompatibility tests conducted on the materials used in the device. Physical testing must be conducted to predict device performance in response to physiological stress, undesirable conditions and forces, long term use, and known possible failures. Any pre-clinical animal studies to support the probability of effectiveness must additionallly be submitted. Objectives, methodology, an analysis of results and conclusion should be shared. More information is available in the PPB's guidelines for registering medical devices here.
Medical devices have the same clinical trial requirements as pharmaceuticals and are included in the clinical trial guidelines.
Applications are submitted to the Clinical Trial Unit of Division of Medicines Information and Pharmacovigilance of the Pharmacy and Poisons Board. Applications must be submitted in both paper (4 bound copies) and electronic format (PDF) on a CDR/flash disk. Requirements are listed in the "Guidelines for Applications to Conduct Clinical Trials in Kenya" here.
▪ Cover letter
▪ Patient Information leaflet and Informed consent form
▪ Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD)
▪ GMP certificate of the investigational product
▪ Signed investigator(s) CV(s)
▪ Financial declaration by Sponsor and/or PI
▪ Signed Declaration by Sponsor or Principal investigator
▪ Indemnity cover and Insurance Certificate for the participants
▪ Copy of favourable opinion letter from the local Institutional Review Board (IRB) and Ethics committee
▪ Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
▪ A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading
▪ Where the trial is part of an international study, sufficient information regarding the other participating countries and the scope of the study in these countries
▪ For multicentre/multi-site studies, an addendum for each of the sites should be provided upon initial application
▪ Registration at the clinical trial registry at www.pharmacyboardkenya.org
▪ Payment of $1000 US (or equivalent in Kenya Shillings) application fee
Check list with documents is available here.
Clinical Trials Import Authorization
Permission to import investigational products is pending approval to conduct a clinical trial. When the research protocol is approved, a request to import the product can be submitted to the Trade Department of the Pharmacy and Poisons Board. An investigator must submit a Clinical Trial Import License and/or evidence of delivery to the approved investigator or trial center.
Clinical Trial Timelines
The decision of the PPB (Approval, Request for Additional Information or Rejection) will be communicated to the applicant within 30 days of the receipt of a valid application.
Clinical Trial Costs
US$ 1000 (or equivalent in Kenya Shillings) per proposal.
Clinical trial guidelines require insurance coverage for study participants.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
2 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
The PPB's "Guidelines on Submission of Documentation for Registration of Medical Devices" outlines the following categories of product registration requirements:
PART 1: ADMINISTRATIVE INFORMATION
1.1. Details of the applicant;
1.2. Product Information;
1.3. Details of the Local Authorized Representative;
1.4. Details of the Manufacturer;
1.5. Quality Systems Standard;
1.6. Details of conformity assessment;
PART 2: SUPPORT INFORMATION;
2.1. Manufacturer certificates;
2.2. Regulatory Approval;
2.3. Post Market Surveillance;
2.4. Product Information;
2.5. Declaration of Conformity;
2.6. Status of Device Distribution;
2.7. Safety and Effectiveness Data;
2.8. Human Clinical Data;
2.9. Stability Studies;
2.10. Manufacturing Information;
2.11. Quality Control Lab requirements;
PART 3: DECLARATION
Product Registration Estimated Timeline
According to the PBB guidelines for medical device registration, once an application has been accepted and evaluation fees paid the processing of application will take 90 calendar days.
Product Registration Costs
The Initial Registration Fee:
Class A: US$ 25.
Class B: US$ 150.
Class C: US$ 200.
Class D: US$ 250.
Class B: US$ 200.
Class C: US$ 250.
Class D: US$ 350.
Class A: US$ 20.
Class B: US$ 100.
Class C: US$ 150.
Class D: US$ 200.
Change Notification Fee:
Class A: US$ 10.
Class B: US$ 20.
Class C: US$ 50.
Class D: US$ 70.
More information on registration fees and classes of devices is available in "Guidelines on Submission of Documentation for Registration of Medical Devices"
Post-Registration Pharmacovigilance Requirements
Manufacturers and local authorized representatives are required to:
a) Maintain Distribution Records to ensure that device distribution channels are traceable and facilitate accountability.
b) Maintain Complaint Handling Procedures and Records-monitor problem reports and corrective actions taken.
c) Maintain Adverse Incident Reporting Procedures and Records-notify the PPB of adverse events as a reuslt of device failure or labeling inadquacy.
d) Have Recall procedures in Place-procedures that will allow manufacturers and local authorized representatives to investigate reported issues.
e) Have field safety corrective action procedures in place.
More information on pharmacovigilance requirements are listed in the "Guidelines on Submission of Documentation for Registration of Medical Devices"
Post Registration Labeling Requirements
Section 41 of the Pharmacy and Poisons Act has outlines labelling for medicines containers.
September 29, 2014.