In Japan, only a local entity qualified as a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH) may import and sell medical products to the Japanese market. This system was implemented to ensure that all imported medical products have a local company in Japan that can take full regulatory responsibility for the imported products. Thus, it is a requirement for all foreign medical device and pharmaceutical companies selling in Japan to assign a MAH or DMAH to manage their product registrations and liaise with Japan’s regulatory authorities.
For more information regarding the MAH and DMAH in Japan, click on the questions below.
What are the responsibilities of a Japan MAH/DMAH?
When a medical product is approved and marketed in Japan, the MAH/DMAH acts as the representative for that product in Japan. Specific duties of the MAH/DMAH include:
- Supervising and managing the manufacturer
- Handling the product registration process and maintaining the product approvals
- Managing product quality and safety and ensuring that all manufacturing sites comply with Japan’s Quality Management System (QMS) requirements
- Managing product storage in an establishment with MAH licensing
- Administering product release to distributors or other sales groups
- Managing post-market surveillance
What is the difference between a MAH and DMAH?
Japan’s Ministry of Health, Labor and Welfare (MHLW) has defined two terms: Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH). The MAH is an entity based in Japan that has obtained the marketing authorization license. If a foreign manufacturer obtains marketing approvals for their product but does not have a local office in Japan, they can designate a DMAH. A DMAH is a MAH assigned by a foreign manufacturer to handle quality control duties within Japan.
The differences between the MAH and DMAH can be summarized as follows:
Marketing Authorization Holder (MAH)
- The MAH controls the registration of the product. The MAH is the applicant and becomes the owner of the approval/certification.
- When the submission of a supplement application or a transfer application of the approval/certification is required, the MAH can submit such an application under their own purview. The MAH is not required to obtain a signature by the foreign manufacturer since the MAH is the owner of the product approval.
Designated Marketing Authorization Holder (DMAH)
- The foreign manufacturer controls the registration of the product. The foreign manufacturer is the applicant and becomes the owner of the approval/certification.
- The DMAH acts as the representative for the foreign manufacturer during and after product registration.
- The application for product registration is submitted through the DMAH, but requires a signature by the foreign manufacturer.
- When the submission of a supplement application or a transfer application of the approval/certification is required, a signature by the representative of the foreign manufacturer is required, although the application is submitted through the DMAH.
- If the foreign manufacturer wants to change their DMAH, it is an easier process compared to changing their MAH
Are all Japan MAH/DMAH licenses identical?
No, the licenses differ and are dependent on various factors. The MAH/DMAH must obtain the appropriate license to cover different products. Foreign pharmaceutical companies without an office in Japan will require a drug DMAH license, while foreign medical device companies will require a medical device DMAH license. For in vitro diagnostic (IVD) products, an IVD DMAH license is required. Also, within each MAH or DMAH license, there are specific sub-groups of categories that need to be obtained for different medical products.
Who can act as a MAH or DMAH?
The MAH/DMAH can be a (1) distributor; (2) an independent third party located in Japan; or (3) the foreign medical company’s subsidiary in Japan.
- A distributor – A cost effective Japan DMAH for foreign companies that do not have their own office in Japan can be the foreign medical company’s distributor in Japan.
- Cost savings. The Japanese distributor DMAH will generally register your product for free, unless local clinical trials are required. After registration, a Japanese distributor DMAH is also normally willing to perform most of the DMAH services without any charges or fees because they expect the sale of the foreign manufacturer’s product to be profitable.
- The potential privacy risks associated with the company’s confidential information. A Japanese distributor acting as your DMAH may acquire knowledge on important facts such as product development and raw materials to register your product that may expose your intellectual property.
- Changing distributors in the future may be a challenging process. If you decide to change distributors down the road, you may be in a difficult situation since your current distributor holds your product licenses and provides DMAH services. In many instances, when the distributor DMAH suspects a loss in profitable business, they may not be inclined to transfer the foreign medical company’s product licenses to another DMAH in Japan. A “friendly” product license transfer from the initial distributor to another new distributor can be very expensive for the foreign manufacturer or lead to your products not being registered in Japan, hence hurting your sales there.
- An independent third party located in Japan
- Protecting the company’s confidential product information. By using an independent third party DMAH, it will be easier to protect your company’s confidential product information, as the independent third party is not a manufacturer and would want to preserve its reputation in the marketplace. At least in theory, such information would be safer with an independent third party DMAH than with a distributor DMAH, who may be acquainted with other industry professionals working in the medical manufacturing field.
- Easier to change distributors in the future. A distributor switch will be much easier if the registration were in the third party DMAH’s name. There are currently a number of DMAH companies in Japan, but only a few reputable Japan DMAHs exist.
- More costs upfront: using an independent third party entity as a Japan DMAH will cost the foreign medical device or drug manufacturer more money upfront since the DMAH will require fees to register your product as well as monthly fees for the DMAH services. Independent DMAH service providers typically offer two types of fee schedules: a flat monthly rate or a lower monthly rate plus a percentage of sales in Japan.
- The foreign medical company’s subsidiary in Japan – Using a subsidiary, branch office, or representative office of the foreign medical company in Japan as the MAH.
- This is an effective route for mid-sized to large companies who already have their own offices in Japan.
- This option would be very difficult and expensive for smaller companies as the foreign medical company’s office must be located in Japan and must meet the MHLW’s MAH standards.
How many controllers make up a MAH or DMAH?
- Three controllers make up a MAH or DMAH, each with its own role in the supervision of marketing, manufacturing and release of the product: (1) General Manager; (2) Post Marketing Safety Controller; and (3) Quality Assurance Controller.
- The General Manager guarantees outstanding quality, marketing, and safety standards of the products and oversees all MAH responsibilities. Requisites for the General Manager Controller include a Bachelor’s Degree in engineering or science and experience of at least three years in a post-marketing safety or quality assurance position at a pharmaceutical or medical device company.
- The Post-Marketing Safety Controller must have three years of prior experience in this field and administrates Good Vigilance Practice (GVP). The controller must conduct post-marketing surveillance, assess safety information, train other personnel in safety assurance, and design and implement measures to enable improved safety. The PMDA must be notified of any adverse events that occur. In addition, the Post-Marketing Safety Controller manages all the proper documentation, including the filing of product safety information. These documents should be available as preparation for a possible inquiry by the PMDA.
- The Quality Assurance Controller manages the Good Quality Practice (GQP) of products. This individual must have a minimum of three years experience in quality assurance control. The PAL requires that the Quality Assurance Controller be in charge of compliance with GQP standards and the new Good Manufacturing Practice (GMP) requirement, based on the Japanese adaptation of ISO 13845:2003. Standard Operating Procedures (SOPs) for GQP consist of quality control at local offices, product storage controls, product release into the market, operation of product recalls and audits, and upkeep of all quality assurance reports and documents. Another duty of the Quality Assurance Controller is the formation and application of the plan of design and development. This will include design verification and validation as well as ways to test product safety and efficacy. The Quality Assurance Controller is also charged with assuring that new GMP regulations are met by the manufacturing facility. Before approving a product, the PMDA may conduct GMP inspections, oftentimes even if the facilities are overseas. Application and maintenance of a Quality System for the product is the responsibility of the Quality Assurance Controller.
- All three MAH controllers are responsible for determining when and how to report adverse events to the PMDA. Ultimately, the PMDA decides the requirements and means for handling adverse events. While adverse events are looked at individually, the PMDA does outline a few general categories and timeframes. First, serious illness and death should be stated within 7 days. Second, physical disorders, hospitalization or other serious events should be reported within 14 days, while less serious events can be reported within 30 days. Presently, the best action to take should an adverse event occur is for an MAH to communicate the effect immediately so as to conclude the best course of action.
What are some examples of the MHLW’s precise requirements regarding the structure of MAH and the personnel required?
- General Medical Devices (Class I) can have a MAH established and managed by one person. This individual acts as all three Controllers and will carry out all obligatory duties.
- Controlled Medical Devices (Class II) must have two people as MAH – one acts as the Post-Marketing Safety Controller while the other acts as the Quality Assurance Controller. Additionally, one of these two people will also need to serve as the General Manager.
- Highly-Controlled Medical Devices (Class III and IV) must have three people for their MAH, and each individual acts as one Controller.
What should be the basis for foreign companies in developing their MAH/DMAH strategy?
Current or expected sales in Japan should be the basis for foreign companies in developing their MAH or DMAH strategy:
- Foreign medical companies with annual sales less than $1 million will typically not choose an independent DMAH in Japan, as the DMAH fees will significantly reduce their profit margins. Because many foreign medical device companies have sales below $1,000,000 in Japan, they oftentimes are willing to take the risk of using their distributor as their Japan DMAH so they do not need to pay upfront fees. If a foreign company falls into this lower sales bracket but is uncomfortable with sharing confidential product information with a distributor, they may decide not to enter the Japanese market at all.
- Mid-sized foreign companies with annual sales between $1 million to $3 million in Japan who do not wish to set up their own office in Japan generally choose to pay the fees for an independent third party DMAH in order to retain their confidential information and to have more control over their product registration and marketing.
- Foreign companies with high annual sales of over $3 million in Japan may decide to set up a branch office or subsidiary office in Japan and use their own employees to act as the MAH. However, setting up an office in Japan can be an expensive endeavor.
Pacific Bridge Medical can act as your Japan DMAH. Appointing an independent third party as your MAH as opposed to a distributor allows for more marketing flexibility and increased control. In this situation, product registrations and licenses can be under the manufacturer’s name instead of the distributor’s name. Changing distributors is far simpler when the registrations are under your own name with the independent third party DMAH.
If you need the assistance of an experienced MAH/DMAH in Japan, contact us today for a free consultation with consultants experienced in handling PMDA regulations.
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