Reference

Marketing Authorization Holder system

The amended Pharmaceutical Affairs Law (PAL), which went into effect in April 2005, has introduced a new marketing business licensing system and has changed the conventional manufacturing approval system to the new marketing approval system. Under the old system, manufacturers manufactured medical devices at their own manufacturing facilities and sold the products manufactured to wholesalers and other distributors. The new system has separated manufacturing and marketing functions so that companies are no longer required to own the facilities where devices are manufactured. Companies are required to obtain marketing approval and a marketing license for each product. To acquire a Marketing Authorization Holder license, the company must be legally registered in Japan. A Marketing Authorization Holder (MAH) license is required to obtain approval/certification for medical devices. The details are described in the Business licenses application section.

Role of a Marketing Authorization Holder(MAH)

The applicant of submissions for medical device approvals/certifications must have an appropriate business license; Marketing Authorization Holder (MAH), according to the Japanese Pharmaceutical Affairs Law. Since only companies registered in Japan can obtain the MAH license, overseas manufacturers must appoint a Japanese company who has the license, as the MAH. Then, the MAH will maintain the medical device approval and registration process. When the medical device is approved and is marketed in Japan, the MAH will act as the representative organization in Japan, and the MAH must have responsibilities of GVP and GQP.
There are two ways to appoint MAH for overseas manufacturers; MAH or DMAH.

What are differences among DMAH and MAH?

MAH: Marketing Authorizationt Holder

• The MAH company controls registration of the medical device. The MAH is the applicant and becomes owner of the approval/certification.
• When a supplement application or transfer application of the approval is submitted, the MAH can submit the application under their responsibilities. There is no requirement of signature by overseas manufacturer, since the MAH is the owner of the approval.

DMAH: Designated Marketing Authorization Holder

• The overseas manufacturer controls registration of the medical device. The overseas manufacturer is the applicant and becomes owner of the approval/certification.
• Since overseas manufacturers cannot obtain the license of MAH, the manufacturer must appoint a Japanese company who has an appropriate MAH license, as the DMAH.
• The DMAH act as representative for the overseas manufacture during and after product registration.
• The application for registration requires signature by the overseas manufacture and is submitted through the DMAH.
• When a supplement application or transfer application of the approval is submitted, signature by the representative person of the overseas manufacturer is required. Then, the application is submitted through the DMAH.
• If the overseas manufacturer wants to change the DMAH company, it’s easier to change compared to the case in MAH.

Rolls/tasks of MAH and DMAH are almost same, such as responsibilities of GVP and GQP. But there are some differences among MAH and DMAH as mentioned in above. Therefore, it should be determined carefully, considering environment and situation of your company and your business partner (ie; subsidiary in Japan, reliability and possibility of your partner in Japan etc.)

 Marketing Authorization Holder system

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

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

*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:

• Retailers can sell medical devices directly to end-users.
• Retailers must sell medical devices in accordance with the MAH’s instructions in terms of product quality, safety and traceability.

MAHs:

• MAHs can import medical devices from foreign manufacturers, and can sell them to retailers.
• MAHs cannot sell medical devices directly to end-users. (One company can have both a MAH license and a retailer license.)
• MAHs must control medical device distribution in terms of product quality, safety and traceability.

(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

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

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

 < RETURN TO “SERVICES”