This slides briefly describe the role of different government bodies in regulation and setting of standards in Uganda. This work was presented on 17th November 2016 at the 5th East African Regional Scientific Conference and Exhibition in Nairobi Kenya at Meridian Hotel. ENJOY!!

1. Regulation And Standards of Medical Devices
And Biomaterials
MATOVU BRIAN
BSc. Biomedical Engineering IV
Makerere university, Kampala
The case of Uganda
Presentation on 17th November at the 5th EA Scientific Conference & Exhibition at Meridian Hotel Nairobi- Kenya

2. Brief CV
Education:
B.Sc. Biomedical Engineering Makerere University 2013-2017.
Extras:
Student member of IEEE EMB
BMET Volunteer in Rwanda with EWH SI 2016
GRC Sch. Biomedical Sciences- Makerere University
Former Gen. Sec. MUBESA 2015/16
contact:
brianmatovu505@gmail.com/ brian.matovu.ug@ieee.org
+256774702067/ 700300518

3. Introduction
Technical health workers in a hospital such as biomedical
engineers and technicians, hospital managers, planning officers,
procurement officers, and other health related stakeholders such
as ministry of health, regulators, manufacturers, NGOs and UN
agencies have a vital role to play as far as patient safety is
concerned in line with patients interacting with medical devices
and biomaterials.
Responsibility

4. The achievement of health-related development goals, including
the SDGs depends upon proper manufacturing, regulation,
planning, assessment, acquisition, management, and use of
medical devices which are of good quality, safe, and compatible
with the settings in which they are used.
Target
A systematic approach to the acquisition, deployment, maintenance,
repair and disposal of medical devices and medical device training
and all should comply to the relevant legislation and guidance.

5. Definition
Medical device means any instrument, apparatus, implement, machine, appliance,
implant, in vitro reagent or calibrator, 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 purposes 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 for medical purposes by means of in vitro
examination of specimens derived from the human body and which does not achieve its
primary intended action in or on the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its function by such means
(GHTF/SG1/N71:2012).

6. Definition
A regulatory authority in this context is a government agency or
other entity that exercises a legal right to control the use or sale of
medical devices within its jurisdiction, and may take enforcement
action to ensure that medical products marketed within its
jurisdiction comply with legal requirements

7. Key factors to consider in regulation:
• Risk assessment and management,
• Building human resource
• Infrastructural capacity for the regulation of medical devices.

8. Brief Background
The 2nd African Regulatory Forum on Medical Diagnostics (21st to 23rd Jan 2014);
 Provide a platform for national regulatory authorities on the continent to share best
practices and interact with medical diagnostics industry.
 Major goal of having a harmonized and functioning regional medical devices and
diagnostics regulatory system within the region in accordance with national and
internationally recognized policies and standards…
 Improvement in the access to safe, efficacious and affordable medical devices and
diagnostics for diagnosis and management of communicable and non- communicable
diseases in the region.
 In-accordance with the mandate provided by Article 118 of the Treaty on the
establishment of the East African Community

9. Uganda Regulatory Agencies
Uganda National Bureau of Standards
Ministry of Health
National Drug Authority
National advisory Committee on
Medical Equipment
Uganda Revenue Authority
National Medical Stores
Professional Bodies
Etc
Gov’t the responsibility to oversee the efforts of manufacturers and vendors and
ensure that MD available in the country are safe and effective. Provide leadership
in creating healthy cooperation among stakeholders in establishing policies and
regulations that are fair and clear to all. Policies and regulations should be
reviewed periodically to respond to changes in technologies by incorporating
appropriate amendments.

10. UNBS
Ministry of Trade, Industry and Co-operatives.
established by the UNBS Act of 1983 and became operational in 1989.
It is mandated to co-ordinate the elaboration of Uganda standards.
Member of the ISO, ARSO and the East African Standards Committee
(EASC).
Has promotional and regulatory roles.
Has Technical committees TC
UNBS/TC14: Medical Devices (formed in 2009)
Rep from JMS, MakSPH, Meridian Techsystem, MOH, Mulago
Hospital Complex, NDA, NMS, Paragon Hospital and UNBS.
Mainly adopts ISO and IEC standards.

11. UNBS
 Follows basic principles of standards development;
 Standards developed at individual/ company level can be adopted
to national level; those at international level can also be adopted to
national level.
 Not many standards developed on national level except just
adoption from ISO and IEC.
 Insufficient expertise.

12. Ministry of Health
 Major regulator of medical devices and other medical supplies
 Sets up policies
 Sets up authorities and committees to oversee the smooth regulation
e.g. NDA and NACME
 Health infrastructure division.
 responsible for health technology policy implementation

13. NACME
 National Advisory Committee on medical Equipment
 Appointed in 1989 by the then Min. of Health
 Reviews the country’s ME need and determines appropriate policy
on procurement, management, disposal and rehabilitation of these
equipment.
 NMEP 1991, 2009
 Works and guides other bodies like NDA, UNBS

14. National Drug Authority
 Responsible for actual regulation.
 Majorly regulates drugs but also responsible for MD regulation;
although not clearly mandated by the law (NDPAA Cap 206)
 Although not clearly by the law, it ensures that valuable new
technologies are made available to the clinical community and to
patients and consumers expeditiously while preventing unsafe or
ineffective devices from reaching the market.
 Quality assurance division.

15. National Drug Authority
 Pre market survey (pre border controls).
 Post market survey
http://www.nda.or.ug

16. Conclusion
 The regulatory landscape for medical devices and diagnostics in Uganda
has been found to be weak and inefficient; but tries.
 Need for better standards to suit the local market.
 Setting up local functional laboratories to test medical devices and
biomaterials.
 Having all the necessary but right stake holders taking part in regulation
and policy making.
 Need to review policies frequently to catch-up with the changing
technology.

17. THANK YOU!