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Thank God we pray to the presence of God Almighty for His grace so that the
preparation of Guidelines for Classification of Medical Devices can be completed.
Under an agreement ASEAN countries on Medical Devices through the
ASEAN Consultative Committee for Standards and Quality Medical Devices Product
Working Group (ACCSQ-MDPWG) that all member states should follow the rules of
the classification of medical devices were harmonized with the ASEAN Medical
Devices Directive (AMDD).
Handbook Classification of Medical Devices and DIV are prepared in
accordance with AMDD to be used as guidelines for health workers central to the
assessment of medical devices in the context of granting a marketing authorization in
accordance with the applicable provisions so that medical equipment that circulated in
Indonesia is guaranteed safety, quality, and usefulness.
Thus, hopefully this guide helpful Classification of Medical Devices.
ii
FOREWORD
DIRECTOR OF MEDICAL DEVICES AND EVALUATION
HOUSEHOLD HEALTH SUPPLIES
iii
TABLE OF CONTENTS
WELCOME ........................................................................................................................................ ii
FOREWORD ................................................................................................................................... iii
TABLE OF CONTENTS ............................................................................................................ iv
PART I
PRELIMINARY ............................................................................................... 1
1.1. Background ........................................................................................ 1
1.2. Legal Basis......................................................................................... 1
1.3. Purpose .............................................................................................. 2
CHAPTER II
CLASSIFICATION OF MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS
invitro ............................................................................................................. 3
2.1 Terms and Definitions ........................................................................ 3
2.2 Classification of Medical Devices ....................................................... 4
2.3 In Vitro Diagnostic Product Classification (DIV) ................................. 6
CHAPTER III
PROCEDURE FOR CLASSIFICATION .......................................................... 8
3.1 MEDICAL DEVICES .............................................................................. 8
3.2 IN VITRO DIAGNOSTIC PRODUCTS ................................................. 12
CHAPTER IV
CLOSING...................................................................................................... 17
ATTACHMENT
iv
PART I
PRELIMINARY
1.1. Background
The function of government supervision in the field of medical devices
is to maintain health and safety of patients and users of medical devices and In
Vitro Diagnostic Products (DIV) to ensure that medical device manufacturers have
to follow the procedures in the design, manufacture, and marketing of medical
devices and products DIV. Medical devices and products DIV at risk from low risk
to high risk of potentially cause serious harm to permanent disability or even
death. The level of government supervision relies on risk medical devices and
products DIV. Therefore, we need a guide in determining the risk class of medical
devices and products DIV. Based on these, guidelines for the classification of
medical devices and products DIV was created as a guide for the central and local
governments and stakeholders in the field of medical devices and products DIV
in determining the risk class of medical devices and products DIV. This
classification guidelines are expected to assist and facilitate the government in
overseeing medical devices and products DIV.
1
2
i. Health Minister Regulation No. 1190 of 2010 on the circulation permit of Medical
Devices
j. Permenkes 1191 of 2010 on Medical Device Distributor License
1.3. Purpose
These guidelines are intended as a guide center officials, the provincial
health department and district / city, businesses and other stakeholders in the
classification of medical devices and products DIV.
CHAPTER II
CLASSIFICATION OF MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS invitro
3
4
If a medical device meets two or more medical devices class rules, then the class of
the medical device determined in accordance with the highest grade, the class with the highest
risk.
6
If a medical device in use are designed to combine with other medical devices,
then each of the medical devices should be classified separately.
DIV product class affects the necessary registration requirements. The higher
grade DIV product, the more the necessary information related to the registration
requirements. The illustration of the relationship between class and registration
requirements DIV product shown in Figure 2.
Regulatory Requirements
HIGHER
LOWER
classification Tool A B C D
Figure 2: Illustration of the increase in regulatory requirements with product risk class DIV
CHAPTER III
PROCEDURE FOR CLASSIFICATION
CONDITIONS
NON-INVASIVE MEDICAL DEVICES
Conditions 1. All non-invasive medical devices that come in direct contact with
the skin is injured:
included in Class A if used as a mechanical barrier, hanyauntuk compression
or abosorpsi exudate, eg healing corresponding main purpose of the use of
medical devices;
including Class B when used in principle in wounds that penetrate the dermis,
including medical devices that are principally intended to handle the
microenvironment (Microenvironment) on the wound.
Except if the medical device is intended principally for healing wounds that
penetrate the dermis and can only heal by secondary purpose of the use of
medical devices, it is included in Class C.
Clause 2. All non-invasive medical devices that are intended to deliver or store
fluid or tissue, fluids or
gas
for the ultimate goal infusion, administration or implantation into the body
belongs to the Class A,
Except if it can be linked to an active medical device Class B or higher grade,
then included in Class B;
blood flow, or
store or other body fluids drain, or storing organs, parts
of organs or body tissues, including in Class B.
Except blood bags, included in Class C.
Conditions 3. All non-invasive medical devices that are used to modify the
biological or chemical components of
blood,
other body fluids, or other
fluids
used for infusion into the body are included in Class C.
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9
Clause 7. All invasive surgical medical devices that are intended for short
periods included in Class B,
Except if it is intended to deliver a drug product, included in Class C; or
Except if intended to undergo chemical change in the body (except if
medical devices are placed inside the tooth), then fall into the Class C; or
Except if it is intended to supply energy in the form of ionizing
radiation, it is included in Class C; or
Except if it is intended to provide a biological effect or be absorbed in part or
whole, are included in Class D; or
Except if it is intended specifically for direct contact with the central nervous
system, it is included in Class D;
Except if intended specifically to diagnose, monitor or correct abnormalities of the
heart or circulatory system center in direct contact with the body parts, then
included in Class D.
Regulation 8. All medical devices that can be implanted and medical
appliance invasive surgery long term, including Class C.
Except intended to be placed in the tooth, it is Class B; or
Except intended to be contacted directly with the heart, the central circulatory
system or the central nervous system, it is Class D; or
Except intended to be used as life support or prolong life, including
Class D; or
Except intended as an active implantable medical devices, it is Class D;
or
Except intended to provide a biological effect or to be absorbed in part or
whole, including Class D; or
Except is intended to deliver a drug product, it is Class D; or
Except intended to undergo chemical change in the body (except if the medical
device is placed inside the tooth), then including Class D; or
Except for breast implants, including Class D.
ON MEDICAL DEVICES
Rule 9 (i). All active therapeutic medical devices that are intended to deliver or
exchange energy are included in Class B,
Except if the characteristics of the medical devices shown to deliver or
exchange energy to or from the human body in a way that is potentially
hazardous, including ionizing radiation, taking into account the nature, density
and location of energy application, included in Class C.
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Rule 9 (ii). All active medical devices intended to control or monitor the
performance of active therapeutic medical devices are included in the Class
C, or intended directly affect the performance of medical devices, including
in Class C.
Rule 10 (i). Active medical devices intended for diagnosis are included in
Class B:
- If medical devices are intended to supply energy which will be absorbed by the
human body (except for medical devices that are used solely to illuminate the
patient's body, with light having the spectrum of visible light or near infrared, it is
Class A), or
- If the medical device is intended to
produces pictures in vitro distribution of radiopharmaceuticals, or
- If intended for direct diagnosis or monitoring vital physiological processes,
Except if the medical device is specifically intended for:
included in Class A.
Rule 15. All medical devices intended specifically to be used to sterilize
medical devices, or disinfected as the end point of processing, included in
Class C.
Except intended for disinfecting medical devices before the end point
sterilization or desinfektasi higher levels, including in Class B; or
Except specifically intended to be used for disinfecting, cleaning, rinsing or, if
appropriate, hydrating contact lenses, included in Class C.
Rule 16. All medical devices used for contraception or prevention of sexually
transmitted diseases, including Class C
unless The medical devices can be implanted or invasive long-term, it
is Class D.
REGULATION 1
DIV products intended for these purposes are classified as class D:
Intended to detect the presence of, or exposure to, intermediary
transmitters that can be transferred / transmitted in blood, blood
components, blood derivatives, cells, tissues or organs in order to assess
their suitability for transfusion or transplantation.
Intended to detect the presence of, or exposure to, intermediary
transmitters that can be transferred / transmitted and cause life-
threatening disease, often can not be cured, with a high risk of spreading.
Example: Test to detect HIV infection, HCV, HBV. This rule applies
for initial testing, confirmatory testing, and additional test.
Rationale:
DIV product of this class is used to ensure the safety of blood and blood
components for transfusion and / or ensuring the safety of cells, tissues, and
organs for transplantation. The test results become important determinants of
whether these donations can be used or not. A serious disease that causes
death or long-term disability, which often can not be cured or in need of treatment
/ therapy major (major therapeutic). Accurate diagnosis is vital to reduce the risk
to public health.
RULE 2:
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patient treatment decisions that lead to situations threatening the life of the
patient.
example: Enterovirus test, CMV and HSV in transplant patients
Intended for screening and selection of patients for the treatment of
specific therapies, or to determine the stage of disease, or a cancer
diagnosis.
example: CD4 test
Intended for human genetic testing.
example: testing of Huntington's disease and Cystic Fibrosis
Intended to monitor drug levels, material or biological component, if there
is a risk that incorrect results will lead to the patient treatment decisions
that lead to situations threatening the life of the patient.
example: cardiac marker (troponin test, test Creatine kinase-myocardial
band (CK-MB), test brain natriuretic peptide (BNP)) and cyclosporin,
Prothrombin time testing.
Intended for the treatment of patients suffering from life-threatening
infections.
example: HCV viral load, HIV viral load, genotyping and subtyping of HIV
and HCV
Intended for screening congenital abnormalities in the fetus.
example: disease testing Spina Bifida, Down's disease testing
syndrome
Rationale:
The application of these rules shall be in accordance with the premise that
medical devices in vitro diagnostics in this class poses a risk to be moderate to
public health, or a high risk for the individual, where the wrong result would put
the patient in a situation which obviously life-threatening, or would have a large
negative impact (major negative impact). In vitro diagnostic medical devices has
become a critical determinant to make the correct diagnosis.
Note: In vitro diagnostic medical devices used in determining therapy choice
decision after further investigation and which are used for monitoring therapy
based on rule 6 will go into class B.
REGULATION 4:
DIV products intended for these purposes are classified as class B:
Intended not to determine medically, or merely a preliminary and require
further medical laboratory testing.
example: own use pregnancy testing, fertility testing, test strips
15
urine.
DIV products intended for these purposes are classified as Class C:
Intended for own use
Intended for the determination of blood gases and blood sugar testing to
patients conducted by health workers but not performed in clinical
laboratories. In vitro diagnostic medical devices other intended for use
near the patient should be classified according to risk using classification
rules.
Example: Monitoring blood sugar.
Rationale :
This tool is used by individuals who do not have the expertise and technical
capability therefore clear information on the labeling and instructions for use are
very important to obtain the proper test results.
RULE 5:
DIV products intended for these purposes are classified as Class A:
Reagents or other materials that have specific characteristics, intended by
the manufacturer to be used in accordance with the procedure DIV
associated with a specific examination.
Instruments intended by the manufacturer specifically for use in
procedures DIV.
the specimen container
Example: microbiological media selective / differential (not including dried
powder which is considered as a finished product), device identification for
the microorganisms have been cultured, wash solution,
instruments and container / cup of urine, sputum, fecal etc.
Note: All products are manufactured, sold or not for use in in vitro diagnostic
medical devices for general laboratory use are specifically not considered as in
vitro diagnostic medical devices, as defined in the guidelines. Although in some
countries the product for general laboratory use can also be viewed as an in vitro
diagnostic medical devices.
Rationale:
The application of this guideline as defined above shall be in accordance with
the foundation that these tools pose a low risk for the individual, and without
menimbulkn risk or with minimal risk to public health.
Note 1: There is a possibility of differences of opinion in some countries about
the tools that are classified in the guidelines are considered as In Vitro
Diagnostics.
Note 2: The performance of the software or instruments required by
16
special and could have done with a particular test will be rated at the same time
with the test kit.
Note 3: The interdependence between the instrument and test methodology
avoids these instruments are assessed separately, even though the instrument
itself is still classified as Class A.
REGULATION 6:
DIV Medical Devices that are not covered in the rules 1-5 are classified into
class B,
Example: H. pylori and markers (markers) of physiological such as hormones,
vitamins, enzymes, metabolic markers, specific IgE assays.
Rationale:
The application of these rules shall be in accordance with the rationale as
follows: These devices pose a moderate risk to individuals because of an
incorrect result is not likely to cause death or severe disability, do not have a
large negative impact (major negative impact) on the patient or put the individual
in immediate danger. In Vitro Diagnostics The results are usually one of several
determinants. If the test result being the only determinant but provided other
information, such as the appearance of signs and symptoms or other clinical
information that could serve as guidelines for doctors, then the In Vitro
Diagnostics are classified into class B. other appropriate control, it could be to
validate the results examination.
This class also includes tools that pose a low risk to public health, because it
detects penginfeksi intermediaries that are not easily spread in the population.
RULE 7:
Controls, calibrators DIV without quantitative and qualitative value is
specified, are classified as Class B.
CHAPTER IV
CLOSING
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18
APPENDIX 1
GLOSSARY
COMMON PEOPLE : are individuals who have no formal training in the field or the
relevant disciplines.
NEAR THE USE OF PATIENT (NEAR PATIENT TESTING):tests performed outside
the laboratory by health professionals but not necessarily by a professional laboratory
personnel, generally located near or next to the patient.
USE OWN: tests performed by a layman.
SPECIMEN CONTAINERS : Equipment, whether vacuum-type or not, specifically
designed by the manufacturer to be the main storage of specimens derived from the
human body.
MEDIUM transmitters : Intermediaries who can spread the disease to someone,
either a highly contagious, spread, or metastasized. TRANSMISSION: transfer of the
disease to someone.
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ATTACHMENT -2
CLASSIFICATION SCHEME FOR MEDICAL DEVICES
CLASS A
CLASS A CLASS C
CLASS B
EXCEPT
EXCEPT EXCEPT
Action is the filtration,
centrifugation or snapped
gas or breath
CLASS B
EXCEPT
Used to deliver
Blood / or store or
Wounds that can only be distribute body fluids
cured by a second act Other / or storing the organ &
body tissue
CLASS C
CLASS B
K. blood
CLASS C
21
APPENDIX 2 CONTINUED
CLASSIFICATION SCHEME FOR MEDICAL DEVICES
Rule 5 Rule 6
Invasive through the body
cavity invasive through
or stoma (not with surgery
surgery) temporary use
CLASS B
EXCEPT
Surgical instruments
CLASS A CLASS C reusable
CLASS A
Short-term P. EXCEPT
Surgical instruments
CLASS B reusable
For use
direct contact system CLASS C
central nervous
used only
CLASS D
in the cavity
mouth, ears or If connected
nose with tools
active health
class B or more Intended to diagnose, monitor
CLASS A high or check for heart abnormalities or
circulation system and contact center
straight to the heart
CLASS B
CLASS D
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APPENDIX 2 CONTINUED
CLASSIFICATION SCHEME FOR MEDICAL DEVICES
Rule 7 Regulation 8
invasive invasive
surgery P. surgery P.
short-term period
Long / implann
CLASS B
CLASS C
EXCEPT
EXCEPT
placed
dispense
the teeth
CLASS C
CLASS B
CLASS D
supplying radiation
ionizing Life support or
survival
CLASS C
active implants
CLASS D
Biological effects or
CLASS D especially uptake
dispense
CLASS D
used contact
directly with
central nervous system CLASS D
CLASS D
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APPENDIX 2 CONTINUED
CLASSIFICATION SCHEME FOR MEDICAL DEVICES
MEDICAL DEVICES ON (1 of 2)
Rule 9 (i)
Therapeutic medical devices Rule 10 (i)
Therapeutic medical
Active meant to devices
give or Active meant to
energy change allow diagnosis
direct / monitoring process
vital Physiology or
supplying energy
absorbed or intended
CLASS B to describe in
radio vivo pharmaceuticals
EXCEPT
CLASS B Rule 10 (ii)
EXCEPT Diagnostic and / or
radiology tool
Used for interventional,
provide / change including control and
energy (referred to radiation monitornya
ionizing) potential
to cause harm Penyerab energy
only for illumination
CLASS C
CLASS A CLASS C
Rule 9 (ii)
Intended for
control, monitor Can cause
or directly immediate danger
affect performance to patients
therapeutic medical devices
class C
CLASS C
CLASS B
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APPENDIX 2 CONTINUED
CLASSIFICATION SCHEME FOR MEDICAL DEVICES
MEDICAL DEVICES ON (2 of 2)
Rule 11 Rule 12
Active medical devices Medical devices
active in addition
to give to the
or move governed by
drug (medicinal Rule 9.10
product) or other
substances or 11
of body
CLASS A
CLASS B
EXCEPT
potentially
inflict
danger
CLASS C
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APPENDIX 3
CLASSIFICATION SCHEME IN VITRO DIAGNOSTIC MEDICAL DEVICES
Y Y
Y Y Y Y Y
Penggolongandar
Pengujianuntukk
ahdenganresikoti
ondisikritis
NGI
D C C C A B B
D B