Regulation And Standards of Medical Devices And Biomaterials

MATOVU BRIANBSc. 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

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

Introduction

Technical health workers in a hospital such as biomedicalengineers and technicians, hospital managers, planning officers,procurement officers, and other health related stakeholders suchas ministry of health, regulators, manufacturers, NGOs and UNagencies have a vital role to play as far as patient safety isconcerned in line with patients interacting with medical devicesand biomaterials.

Responsibility

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.

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).

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

Key factors to consider in regulation:

• Risk assessment and management,

• Building human resource

• Infrastructural capacity for the regulation of medical devices.

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

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.

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.

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.

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

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

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.

National Drug Authority

Pre market survey (pre border controls).

Post market survey

http://www.nda.or.ug

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.

THANK YOU!