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Business licenses for Medical Devices

Business licenses relating to the manufacture, import, wholesale, retail, rental or repair for Medical Devices in Japan are as listed below.

(1) Manufacturer
(2) Marketing Authorization Holder (MAH) & Designated MAH (DMAH)
(3) Manufacturer for Packaging, Labeling and Storage
(4) Retail/Rental Service license
(5) Repair


(1)-(3):Licenses required at the time of submission for approval
(4)-(5):Licenses required after obtaining approval

The relationships linking the various licenses and a product flow are shown below.



*PMDA: Pharmaceuticals and Medical Devices Agenc
*RCB: Registered Certification Body

Fig 1: In case of MAH (Marketing Authorization Holder) company is applicant




Fig 2: In case of overseas manufacturer is applicant


The details of each license are outlined below.


1. Licenses required at the time of submission for product registration

(1)Medical Device Manufacturer

Medical device manufacturers must have appropriate licensing or accreditation when a medical device manufactured at their facilities is registered in Japan.
For domestic manufacturers, a Medical Device Manufacturer license is required.
For foreign manufacturers, the manufacturing facility must be accredited by the Japanese authorities.


(2)Medical Device Marketing Authorization Holder (MAH/DMAH)

When medical devices are registered and marketed in Japan, the MAH is the key organization (as shown in the figures for Case 1 and Case 2).
In Case 2, a DMAH (= Designated MAH) is required to act as a representative organization for the foreign manufacturer.
The requirements and tasks of MAHs and DMAHs are mostly the same.

There are three categories of MAH license, and medical devices that can be handled by the MAH depend on these categories as shown in the table below.

Table1: MAH classifications
MAH classification Scope
1st-class MAH Allowed to handle all classes of medical devices.
2nd-class MAH Allowed to handle Class I and Class 2 medical devices.
3rd-class MAH Allowed to handle Class I medical devices only.

*Differences between MAHs and DMAHs

MAH (Marketing Authorization Holder):
This is the name of the license given to an organization that can act as an applicant/approval holder and is responsible for QA and PMS after product registration.

DMAH (Designated MAH):
This is not the name of the license. A company with a MAH license can become a DMAH to act as an organization representing a foreign manufacturer in its submission of an application for product registration.


(3)Medical Device Manufacturer for Packaging, Labeling and Storage

Facilities where medical devices are packaged, labeled and/or stored are subject to the same standards as those of medical device manufacturers. Accordingly, Medical Device Manufacturer licensing is required for such facilities.


2. Licenses required after medical devices are registered in Japan

(4)Medical Device Retail/Rental Service

Licenses for medical device retail/rental services are necessary for commercial sale or rental of medical devices.
The requirements and tasks related to the license depend on the medical device classification.

*Differences between Retailers and MAHs:

Retailers:

MAHs:


(5)Medical Device Repair

Medical device repairers must have a Medical Device Repair license.
This license has two categories based on 1)the required level of knowledge and skill, and 2)the product type

1)Categorization of required level of knowledge and skill

Table2: Categorization of required level of knowledge and skill
Category Definition
Specially designated maintenance management required medical device MHLW-designated medical devices whose maintenance and repair requires specialized knowledge and skill.
Non- specially designated maintenance management required medical device Devices other than the above

2)Categorization by product type

There are 18 product type categories depending on the required levels of knowledge and skill. The table below shows all categories of Medical Device Repair license.

Table3: Categorization by Products Type
Specially designated maintenance management required medical devices Non- specially designated maintenance management required medical devices
a) Imaging diagnosis systems, etc. a) Imaging diagnosis systems, etc.
b) Measuring/monitoring systems, etc. b) Measuring/monitoring systems, etc.
c) Medical equipment and apparatus for treatment and/or facilities c) Medical equipment and apparatus for treatment and/or facilities
d) Artificial organs, etc. d) Artificial organs, etc.
e) Optical equipment, etc. e) Optical equipment, etc.
f) Physical therapy devices, etc. f) Physical therapy devices, etc.
g) Dental devices, etc. g) Dental devices, etc.
h) In-vitro test devices, etc.*1 h) In-vitro test devices, etc.
i) Steel instruments, home-care products, etc.*2 i) Steel instruments, home-care products, etc.

*1: Some devices were newly designated to this category in the PAL revision of 2005.
*2: No devices are currently designated to this category.



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Please refer to our publication for more detailed information.

"The Japan Medical Device Market and Regulatory Report"

Tokyo time

Business Licenses Application

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