Kenya Medical Device Regulatory Authority
Jenine Killebrew
The site is secure.
The ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.
FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities.
On December 2-4, 2020, MDSAP Regulatory Authorities from the Therapeutic Goods Administration of Australia (TGA), Brazil's National Health Surveillance Agency (ANVISA), Health Canada (HC), Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and the U.S. Food and Drug Administration (FDA) participated in a virtual forum with MDSAP Auditing Organizations. During the forum, regulators from Australia, Brazil and Japan presented the following regulatory updates:
On December 5-6, 2019, FDA participated in the MDSAP Stakeholder Day with the Therapeutic Goods Administration of Australia, Brazil's National Health Surveillance Agency, Health Canada, and Japan's Pharmaceuticals and Medical Devices Agency and regulators from Argentina's National Administration of Drugs, Foods and Medical Devices, Colombia's National Institute for Food and Drug Surveillance, South Korea's Medical Device Safety Bureau, Taiwan Food and Drug Administration and Venezuela's INHRR.
On December 5, 2018, FDA participated in the MDSAP Stakeholder Day with the Therapeutic Goods Administration of Australia, Brazil's National Health Surveillance Agency, Health Canada, and Japan's Pharmaceuticals and Medical Devices Agency and 200 representatives trade organizations and device manufacturers participating in MDSAP.
Kenya is a promising market for medical devices and has been ranked as one of the fastest growing markets in the sub-Saharan Africa region according to Fitch and World Bank reports. The medical device sector is heavily reliant on imports with limited domestic production due to limited manufacturing infrastructure and technical capacity as well as lack of access to raw materials. The U.S. market share for medical devices sales in Kenya was estimated at 5.7% at the end of 2021. The U.S. was ranked eighth after South Africa, with China and Germany taking the first and second places, respectively.
In response to the global economic pressures from the COVID-19 pandemic, the Kenyan government introduced new economic measures in 2020. The corporate income tax rate was reduced from 30% to 25%, and the VAT rate was reduced from 16% to 14%. In addition, the government earmarked $400 million in funds for additional health, including enhanced surveillance, laboratory services, isolation units, equipment, supplies, and communication.
Kenya, like most developing countries, is facing a double burden of communicable and non-communicable diseases. The country is one of the countries in sub-Saharan Africa with the highest prevalence of non-communicable diseases (NCDs). Respiratory diseases continued to be the leading cause of outpatient disease incidence reported in public health facilities. According to the Kenya Medical Research Institute (KEMRI), NCDs such as cancers, diabetes, and others account for 27% of total deaths and over 50% of total hospital admissions.
Public procurement for both medical equipment and pharmaceuticals is done by the Kenya Medical Supplies Agency (KEMSA), a state corporation and a specialized medical logistics provider for the MOH. Centralized purchasing and procurement are often used in both public and private hospitals to obtain economies of scale. K All public tenders are advertised on the KEMSA website and must follow the Public Procurement Act. It is important to highlight that KEMSA is undergoing reforms after concerns by the U.S. Government, among others were brought to light. The agency is still under investigation for concerns regarding fraud, waste, and mismanagement. A report by the Auditor General highlights some of the fraudulent procurements ( -general-presents-damning-special-audit-report-kemsa-senate-committee).
Regulation: The MOH is the lead healthcare policy setting government institution in Kenya. The Pharmacy and Poisons Board (PPB), an agency under the Department of Medical Services at the MOH, is the regulatory body for registration of medical devices.
Kenya has incorporated all medical devices, food supplements, medical cosmetics, herbal products, and other allied borderline healthcare products (these are products that do not fall into the medical devices category, are neither medicinal product nor food supplements) into the pre-export verification of conformity (PVoC) program. The Kenya Bureau of Standards (KEBS) and PPB announced the import requirements to protect the public against products that do not comply with local quality standards and technical regulations. These regulations for imported medical devices increase compliance for importers and improve standards in the Kenyan medical device market. A certificate of conformity (CoC) for customs clearance at the border is required by importers of these products before applying for import license permits from the PPB.
The government also announced the exemption of various medical equipment and apparatus from VAT, under the 2022/2023 budget, which continues to drive and encourage investment in the health sector in Kenya. This includes exemptions for plant and machinery used in manufacturing of pharmaceutical products. The supply of medical oxygen to registered hospitals, urine bags, adult diapers, artificial breasts, and colostomy or ileostomy bags for medical use are also to be exempt from VAT. Learn more about information on vat exemption.
According to Fitch Solutions, these exemptions were meant to support strong medical device market growth, and the sector was expected to register double-digit increases every year between 2019 -2024. There is also a proposal under consideration at the EAC to create a single regulatory body for medical devices across the region under the East African Community (EAC) Medicines Regulatory Harmonization programme.
Diagnostic Imaging Equipment: Leading Kenyan private sector hospital groups invest in the latest most innovative equipment. Best prospects for diagnostic equipment include electrocardiographs (ECG); ultrasound units; scintigraph apparatus; MRI equipment; angiographies; endoscopies; and biochemistry, hematology, and immunology systems. Hospital groups also invest in radiation equipment including, radiotherapy machines, CT scanners, X-ray machines, and imaging parts and accessories such as contrast media, medical x-ray films, x-ray tubes, and other parts and accessories.
Lab testing equipment: Demand for various rapid diagnostic testing kits will reduce with the reduction of COVID-19 cases in the country. Demand for lab equipment and reagents will remain static. The need for self-testing kits will grow steadily as the government approves licensing for RDTs for malaria, HIV, and COVID-19.
Cancer Care: In July 2020, the government announced the opening of ten county chemotherapy centers as part of deliberate efforts to improve access to cancer services in line with the UHC developmental agenda. In addition to the ten centers, the Ministry has also operationalized the Kenyatta University Teaching Referral and Research Hospital and is in the process of establishing five additional radiotherapy centers at the Moi Teaching and Referral Hospital, Nakuru County Referral Hospital, Mombasa County Referral Hospital, Garissa County, and Kisii County. The investments in cancer centers of excellence by both government and private hospitals provide excellent opportunities for U.S. companies.
eHealth and mHealth: Kenya has a well-defined e-Health Policy (2016-2030) outlining key areas of focus and implementation. It has provided a sound policy foundation to manage the rollout of various health information technologies in the country. The country has been ranked the second highest country on the African continent (behind South Africa), on eHealth innovation. These include telemedicine, health information systems, information for citizens, mobile health (mHealth), and eLearning. Kenya has a high mobile phone penetration, which creates a market for eHealth products such as connected devices and patient tracking. the MOH mHealth standards provide a regulatory framework that enables coordination and implementation of robust mHealth solutions. The standardization encompasses communication protocols, device interfaces, applications, and operating systems. These areas present excellent opportunities for U.S. companies in health IT, mobile patient monitoring platforms, and telemedicine.
There is also a demand for supply chain solutions to effectively distribute pharmaceuticals and medical supplies. The enactment of the Special Economic Zones Act (2015-SEZA) presents an opportunity to invest in manufacturing plants for medical supplies to the region.
The International Trade Administration, U.S. Department of Commerce, manages this global trade site to provide access to ITA information on promoting trade and investment, strengthening the competitiveness of U.S. industry, and ensuring fair trade and compliance with trade laws and agreements. External links to other Internet sites should not be construed as an endorsement of the views or privacy policies contained therein. This site contains PDF documents. A PDF reader is available from Adobe Systems Incorporated.
c80f0f1006