MEDICAL DEVICES AND STANDARDS

TMDA AND FDA PRESENTATIONS

Prepared by: JAMES HAKI MAZIKU(UQF6-THIRD YEAR)
HEAD OF INFORMATIONS AND COMMUNICATIONS(BME).
ASSISTANT CLASS REPRESENTATIVE(BME).
CLASSIFICATION OF MEDICAL
DEVICES
By Tanzania Medicine And Medical Devices Authority(TMDA)
INTRODUCTION
• According to TMDA medical devices are classified according to risk
resulting from the use of the device with the implication they
produce either by individual or public

• The classes are as follows;

Class A (low risk)
Class B (low – moderate risk)
Class C (moderate – high risk)
Class D (high risk)
CLASSES OF MEDICAL DEVICES
CLASS RISK LEVEL EXAMPLES

A LOW RISK Bandages, tongue depressor , wheel chair, surgical masks

Surgical retractors

B LOW – MODERATE RISK Hypodermic needles, suction equipment, contact lenses,

hearing Aid

C MODERATE – HIGH RISK X ray machine , lung ventilator,

D HIGH RISK Pacemakers, breast implants, implantable defibrillator

CLASSIFICATION RULES OF MEDICAL
DEVICES
• These classes are classified as provided by set of rules below
• There are classified into 4 groups

Non invasive rules

Invasive rules
Active devices rules
Additional rules
CLASSIFICATION RULES
• NON – INVASIVE DEVICES RULES
• RULE 1: devices come into contact with injured skin. when act as
mechanical barrier are in class A, to manage microenvironment are in
class B, but if injury heal by secondary intent class C

• RULE 2: devices for storing body liquids ,tissue for introduction or

infusion to body are in class A, are in class B when attached by active
devices. Unless blood bags are in class C
CLASSIFICATION RULES
• NON – INVASIVE DEVICES RULES (cont.)
• RULE 3: devices for modifying the biological or chemical composition
of body fluids, for the purpose of infusion are in class A, BUT if the
filtration or centrifuging process takes place are in CLASS B

• RULE 4: otherwise all remaining devices are in CLASS A

CLASSIFICATION RULES
• INVASIVE DEVICES RULES
• RULE 5: devices used to body orifices (not surgical), when not
attached to other devices and used for short time are in class A ,when
used for a long time are in class C. if connected to active devices it is
in class B

• RULE 6: all surgical devices used for short time are in class B, reusable
are In class A, used in nervous system are in class D
CLASSIFICATION RULES
• INVASIVE DEVICES RULES (cont.)
• RULE 7: devices to go in chemical change in the body are in class C
except for those placed in teeth are in class B

• RULE 8 : ALL implantable devices are in class D. except those

implanted on teeth are in class B
CLASSIFICATION RULES
• ACTIVE DEVICES RULES
• RULE 9: all therapeutic devices are in class B, unless uses hazardous
way are in class C

• RULE 10: all diagnosing devices are in class B, unless for patient is in
immediate danger are in class C
CLASSIFICATION RULES
• ACTIVE DEVICES RULES (cont.)
• RULE 11: devices to introduce of remove medicinal product, fluids
into the body are in class B , unless if uses hazardous way are in class
C

• RULE 12: all other active devices are in class A

CLASSIFICATION RULES
• ADDITIONAL RULES
• RULE 13: all incorporating devices if used separately can be
considered as medicinal product are in class D

• RULE 14: all devices made from animal or human tissue are in class D
unless those are in contact with human skin are in class A
CLASSIFICATION RULES
• ADDITIONAL RULES (cont.)
• RULE 15: all devices or for sterilizing or disinfecting medical devices
are in class B unless those disinfecting invasive medical devices are in
class C

• RULE 16: all devices for disinfecting, cleaning, rinsing ,hydrating of

contact lenses are in class C
CLASSIFICATION OF MEDICAL
DEVICES
By Foods And Drugs Administration(FDA)
 INTRODUCTION
Food and drug administration(FDA) is an agency within a department of the

health and human services (HHS)s responsible for regulating the safety and

effectives of the medical device.

Medical device are classified and regulated based on risk passed to the

consumer.
Each regulatory class comprise different
regulatory control which is described below
I. CLASS I. Medical device are considered low risk, such as general
control are considered sufficient to provide reasonable assurance of
safety and effectiveness.
II. CLASS II. Medical device are considered moderate risk, therefore
general and special control are considered to provide reasonable
assurance of safety and effectiveness.
III. CLASS III. Medical device and considered high risk, therefore they are
subjected to general control and premarket approval(PMA)process to
provide reasonable assurance of safety and effectiveness.
Consider the table below.
REGULATORY CLASS LEVEL OF RISK REGULATORY DEVICE TYPES CLASSIFICATION
CONTROL EXAMPLE PANEL
CLASS I LOW GENERAL CONTROL • Elastic bandage General hospital
• Exam gloves
• Hand-held surgical
instrument
• Blood pressure
cuffs
• Dental floss
• Non-powered
wheelchairs
• Tongue depressor

CLASS II MODERATE GENERAL AND • Powered cardiovascular

SPECIAL CONTROL wheelchair
• Pregnancy test kit
• Blood glucose
meter
• CT scan machine
• Infusion pump
• stethoscope
REGULATORY CLASS LEVEL OF RISK LEVEL OF RISK DEVICE TYPES CLASSIFICATION
EXAMPLE PANEL

CLASS III HIGH GENERAL CONTROL • Heart valve General and plastic
PREMARKET • Implantable surgery devices
APPROVAL(PMA) pacemaker
• Deep brain
stimulator
• Artificial
pancreas system
• Spinal cord
stimulator
• Silicon gel-filled
breast prosthesis
CLASSFICATION RULES FOR
MEDICAL
 Intended use
DEVICE
The intended use of the device is a critical factor in classification. The FDA
considers the devices intended purpose its indication for use, medical
condition, its design to diagnose, treat, or mitigate.
 The level of risk posed by the device is a crucial consideration. Devices that
higher-risk, such as those that are invasive, life-sustaining, or have a potential
for serious harm, are more likely to be classified in higher-risk categories.
 Clinical trials and scientific evidence.
For high risk device, the FDA may require clinical data and scientific evidence
to demonstrate the devices safety and effectiveness. This is particularly
relevant for class III device that require premarket approval(PMA).
CLASSIFICATION RULES FOR
MEDICAL DEVICE
 Predicates
The FDA may consider the devices similarities to existing legally
marketed devices, known as predicate devices. If a devices is found to
be substantially equivalent to a predicate device, it may be classified in
the same class.
 Special controls
The FDA evaluate whether the device requires specific performance
standard, post-market surveillance, patient registries, or other special
control to provide reasonable assurance of safety and effectiveness.
JAMES HAKI MAZIKU(UQF6-THIRD YEAR)
MOBILE: +255 762 889 344
+255 778 547 813
EMAIL: jamesmaziku533@gmail.com