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MESSAGE FROM THE DIRECTOR GENERAL OF PHARMACEUTICAL AND

MEDICAL DEVICES MINISTRY OF HEALTH

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.

Jakarta, September 2016


Director General of Pharmaceutical and Medical Devices
Ministry of Health

Dra. Maura Linda Sitanggang, Ph. D


NIP. 2001 19580503 198303

ii
FOREWORD
DIRECTOR OF MEDICAL DEVICES AND EVALUATION
HOUSEHOLD HEALTH SUPPLIES

Praise Gratitude we pray toward the presence of Almighty God upon


perkenanNya and cooperation so that the editorial team of Medical Device
Classification Handbook has been prepared.
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 so drafted
Handbook Classification of Medical Devices
We thank all those who have contributed to the drafting of this technical
manual. It is well known that this book still need improvement, for the expected input
and feedback as an improvement.

Jakarta, September 2016


Assessment Director, Medical Devices and Supplies
Healthy Household
Ministry of Health

drg.Arianti Anaya, MKM


NIP. 2001 19640924 199403

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. Legal Basis


a. Law No. 8 of 1999 on Consumer Protection (Official Gazette of the Republic
of Indonesia Year 1999 Number 42, Supplement to State Gazette of the
Republic of Indonesia Number 3821);
b. Act No. 36 of 2009 regarding Health (State Gazette of the Republic of
Indonesia Year 2009 Number 144, Supplement to the State Gazette of the
Republic of Indonesia Number 5063);
c. Government Regulation No. 72 of 1998 on Safety of Pharmaceutical and Medical
Devices (Official Gazette of the Republic of Indonesia Year 1998 Number 138,
Supplement to the State Gazette of the Republic of Indonesia No. 3781);
d. Minister of Health Regulation No. 76 Year 2013 on Medical Devices
Advertising And Household Health. (Official Gazette of the Republic of
Indonesia Year 2014 No. 192).
e. Minister of Health Regulation No. 70 Year 2014 on the Company Household
Goods Health And Household Health. (Official Gazette of the Republic of
Indonesia Year 2014 No. 1563).
f. Presidential Decree No. 35 2015 of the Ministry of Health
g. Regulation of the Minister of Health No. 64 2015 on the Organization and
Administration of the Ministry of Health
h. Permenkes 1189 Year 2010 Production Certificate and Medical Devices
PKRT

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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

2.1 Terms and Definitions


2.1.1 Medical devices
Medical devices are instruments, apparatus, machinery, tooling, and / or
implant, in vitro reagent, and calibrator, software, material or material that
is used alone or in combination, for human beings with one or more of the
following objectives:
a. diagnosis, prevention, monitoring, treatment, or alleviate disease;
b. diagnosis, monitoring, treatment, alleviate, or restore the injured;
c. examination, replacement, modification, or supporting anatomical or
physiological process;
d. support or sustain life
e. control of conception;
f. disinfection of medical devices;
g. providing information for medical purposes or diagnosis through in vitro
testing of the specimens of the human body which acts primarily in or
on the human body does not reach the pharmacology, immunology and
metabolism, but in achieving its functions can be helped by the process.

2.1.2 Diagnostic Products In Vitro (DIV)


Products Diagnostics In Vitro is any reagents, reagent products, calibrator,
control material, kit, instrument, apparatus, equipment or system, whether
used alone or in combination with other reagents, reagent products,
calibrator, control material, kit, instrument, apparatus, equipment or a
system that is expected by the owner of the products to be used in vitro for
the examination of each of specimens, including blood or tissue donors are
derived from the human body, solely or substantially for the purpose of
providing information:
a. Noting the physiological or pathological state or congenital abnormality

b. To determine the safety and suitability of any blood or tissue donors


with potential recipients, or
c. To monitor the size of the therapy; and includes a specimen container

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2.1.3 Medical Devices Active


Medical devices which are operated using a source of electrical energy or
other energy sources other than those generated directly by the human
body or gravity; which works by changing the energy. Medical devices that
are intended to move the energy, substances or other elements between
an active medical device and the patient, without any significant change,
are not included as active medical devices.
NOTE: Software stand alone (stand alone software), as far as being in the
definition of medical devices, is regarded as active medical devices.
2.1.4 Therapeutically active medical devices
Active medical devices, which are used alone or in combination with other
medical devices, to support, modify, replace or improve the function or
structural biology for the treatment or reduce illness, injury, or disability
2.1.5 Active diagnostic medical devices
Active medical devices, which are used alone or in combination with other
medical devices to provide information to detect, diagnose, monitor or help
deal with physiological conditions, the level of health, disease, or congenital
defects
2.1.6 Non-active medical devices
Medical equipment that is operated using an energy source other than that
used in the active medical devices
2.1.7 Invasive medical devices
Medical devices that penetrate into the body as a whole or in part, either
through a body orifice or through the surface of the body.
2.1.8 Non medical devices invasif
Medical devices that do not penetrate into the body as a whole or in part,
either through a body orifice or through the surface of the body.
2.1.9 duration of Use
1) Brief: use of medical devices continuously for less than 60 minutes
2) Short-term: the use of medical devices continuously from 60 minutes
to 30 days
3) Long-term: the use of medical devices continuously over 30 days

2.2 Classification of Medical Devices


Medical devices are classified based on the risks for the use of medical devices.
Based on these risks, medical devices are divided into four classes as follows
(Table 1):
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1) Class A is a medical device that has a low risk in its use


2) Class B is a medical device that has a low to moderate risk in its use
3) Class C is a medical device that has a moderate to high risk in its use
4) Class D is a medical device that has a high risk in its use

Table 1. Examples of Risk Based Medical Devices

Class risk Example

A Low risk Film viewer, surgical instruments, gloves


surgical gloves, oxygen mask

B Low-Medium Risk Blood pressure cuff, steam sterilizer

C Medium-High Risk Patiet monitors, X-Ray Machine

D High risk Cardiovascular stents, pacemaker

Medical Device Class affect the necessary registration requirements. The


higher class of medical devices, the more the necessary information related to the
registration requirements. The illustration of the relationship between the class and the
Medical Device registration requirements shown in figure 1.

Picture 1. Illustration of the concept of regulatory control enhancement (increased


requirements registration) on medical devices with increased risk classes of
medical devices

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.
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If a medical device in use are designed to combine with other medical devices,
then each of the medical devices should be classified separately.

2.2.1 Factors that affect the classification of medical devices


Classification of medical devices are affected by the following factors:
- The duration of the contact time of the tool body
- Degrees and place the entry in the body
- Combination of medical devices
- Purpose of use as a diagnostic tool or for maintenance
- Local effects against systemic
- The working mechanism in the body
- Biological effects on the body (if appropriate)
- Contact with skin lesions (if appropriate)
- The ability of the tool can be to reuse or not

2.3 In Vitro Diagnostic Product Classification (DIV)


DIV product risk class classification affected by the risk factors of the individual
and the risk to public health (public health). Based on these risks, product DIV divided
into four classes as follows (Table 2)
1) Class A is the DIV product that has a low risk to the individual (low
individual risk) and the risk to public health is low (low public health risk)
2) Class B is a product that has a risk DIV against individuals (moderate
individual risk) and the risk to public health is low (low public health risk)
3) Class C is the product DIV against individuals who have high risk (high
individual risk) and the risk to public health (moderate public health risk)
4) Class D is the product DIV against individuals who have high risk (high
individual risk) and the risk to public health (high public health risk)

Table 2. Examples DIV Products Based on Risk


CLASS RISK EXAMPLE
Clinical chemistry test
risk to individual low equipment (clinical
(Low individual risk) and risks chemistry analyzer), Test
A
to lower public health cholesterol, uric acid test
(Low public health
risk)
moderat
risk to individual e pregnancy tests use
B (Moderate individual risk) and own (self pregnancy testing)
risks to health public
7

Low (low public health risk)


individu
risk to al high Blood sugar test tool usage
(High individual risk) and risks alone,
C public health surveillance is being HLA typing,
(Moderate public health risk) PSA screening,
rubella
individu
risk to al high HIV screening of blood donors,
(High individual risk) and risks HIV blood diagnosis
D
to health public high
(High public health risk)

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

3.1 MEDICAL DEVICES


The classification of medical devices using the following procedure:

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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Except treatment consists of filtration, centrifugation or exchange of gas or


heat, it is included in Class B.
Conditions 4. Non-invasive medical devices more included into Class A.
INVASIVE MEDICAL DEVICES
Provisions 5. All invasive medical devices associated with a body cavity
(other than surgical invasive medical devices) and the
is not intended to be connected to an active medical device, or is intended
to connect with medical devices Class A only.
- included in Class A if used only temporarily;
Except if the medical device is intended by the owner to be used on the outer
surface of the eyeball; or possible is absorbed by the mucous membrane, it is
included in Class B.
- included in Class B when used in the short term;
Except if the medical device is intended for short-term use of the oral cavity
to the pharynx, the ear canal up to the eardrum or nostrils, then included in
Class A.
- included in Class C if used for long-term;
Except if it is used in the long term in the oral cavity to the pharynx, the ear
canal to the eardrum or the nostrils and is not to be absorbed by the mucous
membrane, it is included in Class B.
All invasive medical devices associated with a body cavity (other than medical
devices used in invasive surgery) intended to connect with medical devices
Class B or a higher class, included in Class B.
Provisions 6. All invasive surgical medical devices that are used to
temporarily included in Class B,
Except surgical tools are used repeatedly, including in Class A; 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 C; or
Except if it is intended to deliver a drug product through a delivery system,
if this is done in a manner that is potentially dangerous applications, then
fall into the Class C; or
Except if it is intended specifically for direct contact with the central nervous
system, it is included in Class D; or
Except if it is intended specifically to diagnose, monitor or correct
abnormalities of the heart or central circulatory system through direct
contact with body parts, then included in Class D.
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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:

- critical monitoring of physiological parameters, where the variation of the


physiological parameters may result in danger to the patient, for example,
variations on the work of the heart, respiratory, central nervous system activity, or
- diagnose clinical situations where patient in danger, then it belongs to
the class C.
Rule 10 (ii). Active medical devices intended to emit ionizing radiation and
intended for the diagnosis and / or
interventional radiology, including medical devices which control or monitor
such medical equipment or medical devices that directly affect performance,
including Class C.
Rule 11. All medical devices intended to deliver and / or eliminate the drug
product, body fluids or other substances to or from the body, including Class
B.
Except this is done in a way that is potentially hazardous, taking into
account the nature of the substances involved, as well as the associated
body part mode and route of administration or omission, including a class C
Rule 12. All other active medical devices included in Class A.
ADDITIONAL REGULATIONS
Rule 13. All medical devices containing the substance, where the substance if
used alone can be considered a medicinal product (as defined by the member
states) acting on the human body through the action of the investigation of
medical devices, including in Class D.
Rule 14. All medical devices are made from or incorporate
- Cells and tissues of animals and / or its derivatives, which do not live, or
- Cells and tissues microbial or recombinant origin, and / or derivatives
included in Class D,
Except The medical devices manufactured from or incorporating animal
tissues or derivatives that do not live in contact with the skin only,
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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.

3.2 IN VITRO DIAGNOSTIC PRODUCTS


DIV product classification using the following procedure:

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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DIV products intended for these purposes are classified as Class C:


Aimed at determining the classification of blood or tissue typing to ensure
the immunological compatibility of blood, blood components, cells, tissues,
or organs intended for transfusion or transplantation.
example: tissue typing test Human leucocyte antigen (HLA-A, HLA-B,
HLA-C, HLA-D).
DIV products intended for these purposes are classified as class D:
Aimed at determining the classification of the blood of the ABO system [A
(ABO1), B (ABO2), AB (ABO3)], the system rhesus [RH1 (D), Rh2 (C),
RH3 (E), RH4 (c), RH5 (e )], Kell system [Kel1 (K)], Kidd system [JK1
(Jka), JK2 (Jkb)] and
Duffy system [FY1 (Fya), FY2 (Fyb)]
example: blood typing test (Anti-A, Anti-B, anti-A, B)
Rationale:
The application of this rule as defined above should be in accordance with the
premise that the high risk to individuals, where the wrong result would put the
patient on a life-threatening situation is clear, make these tools fit into class D.
The rule divides blood into the classification equipment two classes of class C
or D, depending on the nature of the blood group antigens to be detected by in
vitro diagnostic medical devices are, and this is very important in setting the
transfusion process.
REGULATION 3:
DIV products intended for these purposes are classified as Class C:
Intended to detect the presence of, or exposure to, an intermediary
transmitting sexually.
example: Test Chlamydia trachomatis, Neisseria gonorrhoeae test.
Is intended to detect the presence of an intermediary penginfeksi in
cerebrospinal fluid or blood to the risk of spread is limited.
example: Neisseria meningitidis test, test Cryptococcus neoformans.
Is intended to detect the presence of an intermediary penginfeksi that
pose great risk, if the result is wrong will lead to death or severe disability
of the individual or fetus being tested.
example: Diagnostic tests for CMV (Cytomegalovirus), Chlamydia
pneumoniae test, test Methycillin resistant Staphylococcus aureus.
Intended for pre-natal screening to determine immunity to intermediaries
transmitters that can be transferred.
example: Rubella immunity test, Toxoplasmosis
Intended to determine the status of infectious diseases or immune status,
and if there is a risk that incorrect results will lead to an
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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
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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
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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

Classification guidelines to improve the use of medical devices is good, so


hopefully minimize the risk of the use of this kesehatan.Untuk all would require a
competent resources in terms of classification of medical equipment from center
officials, the provincial health department and district / city, businesses and other
stakeholders ,
Hopefully, by the human resources who have the competence, the risk can
be decreased use of medical devices.

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APPENDIX 1
GLOSSARY

SYSTEM OF CENTRAL BLOOD CIRCULATION: For the purposes of these


guidelines, the central circulatory system means internal large blood vessels,
including the following:
- arteriae pulmonales (pulmonary artery);
- ascendens aorta (ascending aorta);
- coronariae artery (coronary artery);
- common carotid artery (common carotid artery);
- carotid artery externa (external carotid artery);
- internal carotid artery (internal carotid artery);
- arteriae cerebrates (cerebella arteries);
- truncus brachiocephalicus (brachiocephalic trunk);
- venae cordis (cardiac veins);
- venae pulmonales (pulmonary vein);
- venae cava superior (superior vena cava);
- venae cava inferior (inferior vena cava);
- arcus aorta (aortic arch);
- thoracica aorta (thoracic aorta);
- The abdominal aorta (abdominal aorta);
- Ilica arteriae communis (common iliac arteries);
- descendens to the bifurcatio aorta aortae (descending aorta to the bifurcation of
aorta)
CENTRAL NERVE SYSTEM : For the purpose of these guidelines, refer to the
central nervous system in the brain, meninges, and spinal cord.
HOLE BODY: Every natural openings in the body, as well as the outer surface of the
eyeball, or permanent artificial opening, such as a stoma or permanent
tracheostomy. EXAMINATION: This series of work aimed to determine the value of
something
NOTES: examination of analytes in biological samples is often referred to as a test,
research or analysis.
INSTRUMENTS: equipment or apparatus intended by the owner of the product to be
used as a health tool DIV.
FOR IN VITRO DIAGNOSTIC USE ONLY: all In Vitro Diagnostic medical devices
intended by the manufacturer to be used by laymen. DAMAGES (harm) is an injury or
physical disability in people or damage to objects or environments.
THE INTENDED USEis a manufacturer of interest related to the use of a product,
process or service as reflected in the specifications, instructions and information
provided by the manufacturer.
Reagents: components of chemical, biological or immunological solution or
preparation that is intended by the manufacturer to be used as an In Vitro
Diagnostics.
19

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.
20

ATTACHMENT -2
CLASSIFICATION SCHEME FOR MEDICAL DEVICES

NON INVASIVE MEDICAL DEVICES

Rule 1 Rule 2 Rule 3 Rule 4


Is the contact distribute or modifying biology Medical devices
other than those
with a skin wound save or chemical composition set
and dimasudkan fluids / tissues blood / fluid Peraturan1,2 or
as barir, or body / gas Body / other fluids 3
compression, absorbent intended intended for
droplets. infusion and infusion.
drug.

CLASS A
CLASS A CLASS C
CLASS B

EXCEPT

EXCEPT EXCEPT
Action is the filtration,
centrifugation or snapped
gas or breath

Intended primarily to CLASS B


penetrate the outer layer of
skin wounds

CLASS B May be associated with


an active medical device class B
or higher

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

INVASIVE MEDICAL DEVICES (1 of 2)

Rule 5 Rule 6
Invasive through the body
cavity invasive through
or stoma (not with surgery
surgery) temporary use

CLASS B

EXCEPT

Peng. while P. Long Term

Surgical instruments
CLASS A CLASS C reusable

CLASS A

Short-term P. EXCEPT

Surgical instruments
CLASS B reusable

used only Biological effects or


in the cavity especially uptake CLASS C
mouth, ears
or the nose is not
such that CLASS C
absorbed by
mucous
EXCEPT membrane
Giving drugs
potentially menimbalkan
CLASS B drug

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
22

APPENDIX 2 CONTINUED
CLASSIFICATION SCHEME FOR MEDICAL DEVICES

INVASIVE MEDICAL DEVICES (2 of 2)

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

Experiencing changes used contact


chemical in the body directly with
(Not including teeth) heart, circulatory system
or central nervous system
center
CLASS C

CLASS D

supplying radiation
ionizing Life support or
survival

CLASS C
active implants
CLASS D

Biological effects or CLASS D


especially uptake

Biological effects or
CLASS D especially uptake

dispense
CLASS D
used contact
directly with
central nervous system CLASS D

CLASS D Experiencing changes


chemical in the body
(Not referred to the
teeth)
Intended to diagnose,
monitor or check Breast implants
cardiac abnormalities or
system CLASS D
circulation and contact center CLASS D
straight to the heart

CLASS D
23

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
24

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
25

APPENDIX 3
CLASSIFICATION SCHEME IN VITRO DIAGNOSTIC MEDICAL DEVICES

rule 1 rule 2 rule 3 rule 4 rule 5 rule 6 rule 7

Penapisa conformity Disease examination IVD Reagents No Control


ndarah blood or spread alone specific reply including who does
Disease Network Ujipenyakit testing " Instrument rule 1-5 not
with donor cancer near WadahSpe memberika
risks with diagnosis patient " simen nnilai
high receiver broadcaster
examinatio
N N genetic testing N N N N n
filtering
Disease
congenital

Y Y
Y Y Y Y Y
Penggolongandar
Pengujianuntukk
ahdenganresikoti
ondisikritis
NGI

D C C C A B B
D B

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