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Classification of Medical Devices

For medical devices manufactured, imported and/or sold in Japan, Japanese Medical Device Nomenclature (JMDN) codes and generic names are set with reference to the medical device names determined in the ISO/TC210 GMDN project.
Then, generic names are classified to Class I, II, III or IV according to their risk levels. These classifications were determined by reference to the classification rule of GHTF (Global Harmonization Task Force).

General medical devices (Class I)

General medical devices (Class I) are those other than specially controlled medical devices and controlled medical devices that are deemed by MHLW to pose an almost insignificant risk to human life and health in the event of malfunction or adverse events. Although they do not require process for approval, notification must be submitted to PMDA.
Class I medical devices can be marketed after the notification process. Documents for notification should include device descriptions (appearance, dimensions, materials, specifications, manufacturing process, etc.). Notification involves no review by the authority – it can be seen as a process of self-certification.

  • The applicant for the notification has to have a 3rd grade Marketing Authorization Holder (MAH) license.
  • The manufacturing facilities has to be registered as medical device manufactures.

Followings are examples of medical devices classified to Class I.
X-ray film, steel surgical instruments, etc.

Controlled medical devices/designated controlled medical devices (Class II)

Controlled medical devices/designated controlled medical devices (Class II) are those other than specially controlled medical devices that are deemed by MHLW to require management in relation to the relatively low potential risk they pose to human life and health in the event of malfunction or adverse events.
Most Class II medical devices require a process known as certification, which involves review by a registered certification body (RCB). RCBs perform review in line with the applicable certification standards, and also implement QMS auditing.
Applications for certification must include device descriptions (appearance, dimensions, materials, specifications, manufacturing process, etc.) and a STED (Summary of Technical Documents), in which conformity to the certification standards should be shown.
Class II medical devices that do not meet the requirements for certification must undergo to the process of approval. For more details, see the description for Class III and Class IV below.
Medical devices categorized as Class II are further regulated as follows:

  1. Medical devices, which have not applicable certificate standards, are categorized as controlled medical device, and need approval reviewed by PMDA.
  2. Medical devices, which have and meet applicable certification standards, are categorized as designated controlled medical devices, and need certification reviewed by a Registered Certification Body (RCB).
  3. Common requirements for class II medical devices.
  • The applicant has to have a 2nd grade MAH license.
  • The manufacturers has to be registered as medical device manufactures.
  • Manufacturers has to comply with the Quality Management System (QMS) requirements set by MHLW ordinance 169.

Followings are examples of medical devices classified to Class II.
MRI systems, electronic sphygmomanometers, electronic endoscopes, ultrasonograph equipment, dental alloys, etc.

Specially controlled medical devices (Class III and Class IV)

Specially controlled medical devices (Class III & IV) are those deemed by MHLW to require appropriate management in relation to the relatively high or potentially fatal risk they pose to human life and health in the event of malfunction or adverse events. Such devices are categorized as Class III or Class IV.
Class III and IV medical devices require submission of applications for approval, which are reviewed by PMDA (the Pharmaceuticals and Medical Devices Agency), mostly. As Class III and Class IV cover a variety of medical devices, there are several application categories as shown in the Table 2. The requirements, review term and cost depend on the application categories.
On the other hand, there are some Class III medical devices for which certification standards (Ninsho standards) are defined. For such products, the applications should be submitted to and reviewed by RCBs.

The following requirements apply to all Class III and Class IV medical devices

  • The applicant has to have a 1st grade MAH license.
  • The manufacturers has to be registered as medical device manufactures.
  • Manufacturers has to comply with the Quality Management System (QMS) requirements set by MHLW ordinance 169.

Followings are examples of medical devices classified to Class III or IV.
Class III: hemodialysis equipment, artificial bones and joints, mechanical ventilation apparatus, balloon catheters, etc.
Class IV: pacemakers, artificial cardiac valves, stents, etc.

Table1: Medical Device Classifications
Classification Definition Registration category Review body
ClassⅠ The risk to patients in the event of malfunction is regarded as almost negligible. Notification NA
ClassⅡ The risk to patients in events of malfunction is regarded as relatively low. Certification
or
Approval		 RCB*2
or
PMDA*1
ClassⅢ The risk to patients in events of malfunction is regarded as relatively high. Approval
or
Certification		 PMDA*1
or
RCB*2
ClassⅣ The device is highly invasive with potentially fatal risk to patients. Approval PMDA*1

*1 PMDA: Pharmaceuticals and Medical Devices Agency
*2 RCB: Registered Certification Body

Table2: Application categories for medical device approval
Application category Overview
New medical devices Medical devices that are clearly different from those with approval or certification in Japan in terms of structure, methods of use, efficacy and/or performance.
Clinical evaluation is required, basically.
Improved medical devices Medical devices, which are not applicable to “New medical devices” nor “Me-too medical devices.”
In the case that safety and efficacy cannot be proven by non-clinical data, clinical evaluation is required.
Medical devices, which are substantially equivalent to predicate products in terms of safety and efficacy.
Generic medical devices There are approval standards for some generic names.
Clinical evaluation is not required.
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