“Classifications of Medical Devices” and TDK Products’ Coverage of Those Classes

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》Application Guide Medical equipment

Medical devices are classified according to the risks that could affect the human body.
In each country, medical devices are classified into classes based on the GHTF (Global Harmonization Task Force) rules.

  • ●In Japan, medical devices are classified, under the PMD Act*, into Classes I, II, III, and IV that are announced by the Ministry of Health, Labour and Welfare.
    *PMD Act: the common abbreviated name for the Pharmaceuticals and Medical Device Act, which is the title of the revised Pharmaceutical Affairs Law (“The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices”) that came into effect in November 2014.
  • ●In the U.S., medical devices are classified as Class I, II, or III under the FD & C Act (Federal Food, Drug, and Cosmetic Act), which is known as the FDA (the Food and Drug Administration) classification.
  • All medical devices have “nonproprietary names.”
    There are more than 4,000 Japanese Accepted Names, which are based on GMDM (Global Medical Device Nomenclature) and established as JMDM(Japanese Medical Device Nomenclature). Please be informed that class classifications and Japanese Accepted Names are updated from time to time.
  • ”Classifications of medical devices” and the coverage of those classes by TDK’s products
    TDK provides various products classified as the products of the following classes (except for implantable medical devices). Please feel free to inquire us for more details.

Classifications of Medical Devices

Japan
Classification according to the PMD Act
(Revised Pharmaceutical Affairs Law)
Class I: General medical devices
Medical devices whose malfunction influence on the human body is supposed to be minor, including:
Analyzers of the class other than Class II or III, such as those to be mentioned below.
* The following analyzers, however, require the minister’s authorization and their class is determined at the time of such authorization: those that are used for a new test item or new measurement principle, those that will undergo a transition to a self-test device, and those for a dedicated use containing major reaction systems that are used to measure a new test item.
[Examples]
In vitro diagnostic devices, steel instruments, dental laboratory equipment, X-ray films, stethoscopes, mercury blood pressure gauge, etc.
Class II: Controlled medical devices
Medical devices with a low possibility of causing a life-threatening danger or critical functional failure, including:
Analyzers, such as:
(1) self-test diagnostic equipment that is used for a test item other than those that could threaten the life or significantly harm the health of the patient when the equipment indicates an incorrect diagnostic result (and self-test diagnostic equipment with which the diagnostic result does not establish a medically-critical condition or those with which the diagnostic result is tentative and requires another appropriate follow-up examination); and
(2) dedicated-use analyzers containing major reaction systems, those that do not have a standard product (except for Class III items).
[Examples]
Diagnostic imaging equipment, contrast medium injectors, electronic thermometers, electronic blood pressure gauge, electronic endoscopes, dental alloys, etc.
Class III: Specially controlled medical devices
Medical devices whose malfunction is supposed to cause a major influence on the human body, including:
Analyzers, such as:
(1) self-test diagnostic equipment that is used for a test item that can threaten the life or significantly harm the health of the patient when the equipment indicates an incorrect diagnostic result; and
(2) dedicated-use analyzers containing major reaction system, those that are used to measure a test item for which an in vitro diagnostic is required to get authorized.
[Examples]
Dialysis machines, head prostheses, radiation therapy equipment, blood vessel stents, biliary stents, extracorporeal shock wave lithotripsy equipment, general-purpose infusion pumps, etc.
Class IV: Specially controlled medical devices
Medical devices that are highly invasive whose malfunction is supposed to threaten the life of the patient.
[Examples]
Pacemakers, coronary artery stents, absorbable surgical sutures, mammary prostheses, video image flexible vascular endoscopes, central venous catheters, etc.
U.S.A.
FDA Classification
Class I: General Controls
Medical devices whose defect or malfunction is not supposed to cause any major harm to the patient or user; a group of medical devices which require minimum legal control.
[Examples]
In vitro diagnostic devices, steel instruments, dental laboratory equipment, X-ray films, stethoscopes, mercury blood pressure gauge, etc.
Class II: General Controls and Special Controls
Medical devices carrying higher risks than those of Class I; a defect or malfunction of medical devices of this class is supposed to have a possibility of causing an injury to the patient.

[Examples]
Electric wheelchairs, infusion pumps, etc.
Class III: General Controls and Premarket Approval
Medical devices carrying the highest risks; a defect or malfunction of a medical device of this class is supposed to have a possibility of causing a severe disorder or death to the patient. Many of the medical devices of this class are products used to rescue or support a life, but they carry latent and irrational disease- or injury-related risks.
[Examples]
Implantable heart valves, implantable cerebellar stimulators, etc.
Coverage by TDK products
We can provide most of the products, except for some.
Please feel free to inquire us for more details.
Currently we do not have a product.