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Japan's 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 level. These classifications were determined by reference to the classification rule of GHTF (Global Harmonization Task Force).


(1) General medical devices

-Class I medical devices-

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 side effects. Although they do not require approval, notification must be submitted to PMDA, and the requirements outlined below must be met.

Class I medical devices can be marketed after a registration process known as notification. Applications for notification should include device descriptions (appearance, dimensions, materials, specifications, manufacturing process, etc.). Notification involves no review – it can be seen as a process of self-certification.

No QMS audit is required.

– The applicant must have a 3rd grade Marketing Authorization Holder (MAH) license.
– The manufacturing facility must have a license for medical device manufacture.

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

(2) Controlled medical devices/designated controlled medical devices


-Class II medical devices-

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 side effects.

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:

a) Medical devices, which have not applicable certificate standards, are categorized as controlled medical device, and need approval reviewed by PMDA.

b) Medical devices, which have and meet applicable certification standards, are categorized as designated controlled medical devices, and need certification reviewed by and Registered Certification Body (RCB).

c) Common requirements for class II medical devices.

– The applicant must have a 2nd grade MAH license.
– The manufacturer must have a license for a medical device manufacture.
– Manufacturer must comply with the quality management system (QMS) requirements set by MHLW ordinance 169.

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

(3) Specially controlled medical devices

-Class III and Class IV medical devices-

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 side effects. 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). As Class III and Class IV cover a variety of medical devices, there are several application categories as shown in the table below. The requirements, review term and cost depend on the application categories.

The following requirements apply to all Class IV medical devices:
– An application for approval must be submitted to the Pharmaceuticals and Medical Devices Agency (PMDA – the approvals review body).
– The applicant must have a Marketing Authorization Holder (MAH) license.

GQP & GVP requirements:
– The manufacturing facility must advance registration for manufacture.
Requirements for buildings and facilities:
– Manufacturing facilities must comply with the quality management system (QMS) requirements set by MHLW ordinance.

Regarding the device for Class III are further regulated as follows:
a) Medical devices without certification standards that are classed as specially controlled medical devices need PMDA approval;
b) Medical devices with certification standards that are classed as specially controlled medical devices need review by an RCB (registered certification body – a third-party organization).

For Class III medical devices without certification standards:
– An application for approval must be submitted to PMDA.

For Class III medical devices with certification standards:
– Certification by an RCB is necessary.
– The applicant must have a MAH license.

GQP & GVP requirements:
– The manufacturing facility must advance registration for manufacture.
Requirements for buildings and facilities:
– Manufacturing facilities must comply with the quality management system (QMS) requirements set by MHLW ordinance.


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.


The related registration processes and requirements depend on the classification as shown below.
Table 1 shows the Japan's classification for medical devices
Table 2 shows the application categories for medical device approval.


Table1: Medical Device Classifications
Japan PAL class. Risk class. Definition Registration category Review body
General medical device Class I The risk to patients in the event of malfunction is regarded as almost negligible. Notification Self Declaration
Controlled medical device Class II The risk to patients in the event of malfunction is regarded as relatively low. Certification or   Approval RCB *1
or
PMDA *2
Specially controlled medical device Class III The risk to patients in the event of malfunction is regarded as relatively high. Certification or   Approval RCB *1
or
PMDA *2
Class IV The device is highly invasive with potentially fatal risk to patients. Approval PMDA *2

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




Table2: Application categories for medical device approval
Application category Overview
New medical devices

(Clinical trial data required)
Medical devices that are clearly different from those with approval or certification in Japan in terms of structure, principle, method of use, efficacy and/or performance.
GCP clinical trial data must be provided to prove clinical safety and efficacy.
Improved medical devices

(Clinical trial data required)
This category is for medical devices that:
- do not have an applicable approval standard or do not meet the requirements of the approval standard;
- cannot be proven to be me-too devices (see “Me-too” medical devices below);
- are not regarded as new medical devices (see the above section); and
- cannot be proven safety and/or efficacy with non-clinical data.
GCP clinical trial data must be provided to prove clinical safety and efficacy.
Improved medical devices

(Clinical trial data NOT required
and
Not compliant with approval standards)
This category is for medical devices that:
- do not have an applicable approval standard or do not meet the requirements of the approval standard;
- cannot be proven to be me-too devices (see “Me-too” medical devices below);
- are not regarded as new medical devices (see New medical devices above); and
- can be proven safety and efficacy with non-clinical data.
GCP clinical trial data is not needed to prove safety and efficacy.
”Me-too” medical devices

(Clinical trial data NOT required
and
Not compliant with approval standards)
This category is for medical devices regarded as the “Me-too” type that;
- do not have an applicable approval standard or do not meet the requirements of the approval standard;
- are not regarded as new medical devices and as Improved medical devices;
- can be proven safe and effective with non-clinical data.
GCP clinical trial data is not needed to prove safety and efficacy.
In the application documentation for the “me-too” category, substantial equivalence to predicate devices in Japan must be clearly shown.
”Me-too” medical devices

(Clinical trial data NOT required
and
Compliant with approval standards)
This category is for medical devices regarded as the “Me-too” type that;
- have an applicable approval standard and meet the requirements of the approval standard;
- can be proven compliance to the approval standard.
GCP clinical trial data is not needed to prove safety and efficacy.
In the application documentation for the “me-too” category, substantial equivalence to predicate devices in Japan must be clearly shown.
A total of 40 approval standards were in place as of January 2011.


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Please refer to our publication for more detailed information.

"The Japan Medical Device Market and Regulatory Report"

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