June 12, 2018
A research conducted by BMI Espicom showed that the scale of the global medical device market is expected to reach US$38.91 billion in 2019, of which Japan has the world’s second largest medical device market, second to United States. Global medical equipment manufacturers in addition to Europe and the United States well-known manufacturers (GE, Medtronic, Johnson & Johnson, etc.), Japan's endoscope manufacturer OLYMPUS, digital blood pressure machine Terumo, in vitro diagnostic reagents Sysmex, etc. accounted for major sum of the global medical market revenue. The number is expected to reach 3 trillion yen by 2021, according to Ministry of Health, Labor, and Welfare. (See Table 1 as below)
Although Japan is a large exporter, imports account for over half of Japan’s domestic medical equipment market. To minimize costs, Japanese companies have expanded overseas. Devices are manufactured and imported from Southeast Asia to meet domestic demands. As a response to challenges of aging population and increasing consumption, many foreign companies have targeted the market for the introduction of medical equipment to the country.
Table 1. The market scale of medical device in Japan
Source: MHLW, BMI Research, Worldwide Medical Devices Forecasts to2
Unit: hundred millions of Yen (JPY)
Figure 1. 2018 Medtec Exhibition in Tokyo
How do foreign companies begin their layout in Japan?
Foreign manufacturers and companies usually set up new branches/ subsidiaries to be able to qualify for any commercial activities within Japan. However, after the revision of the Japanese PMD Act, a “Foreign Special Case Recognition Policy” was introduced to allow foreign companies to qualify for the domestic sale of medical devices even if they are located abroad. This implies several benefits for foreign Small to Medium Enterprises (SMEs).
Enterprise System Qualification & Product Licensing Qualification
Enterprise System Qualification:
Foreign manufacturers must comply to at least one of the following methods to distribute/sell medical device in Japan:
- Establish a company as Japanese legal person and obtain Marketing Approval Holder (MAH) certification.
- To allow domestic companies with MAH to register a license for product and sales.
- To allow a suitable "Designated Marketing Approval Holder (DMAH)" in Japan to carry out all actions related to product license application, import, distribution, and other product quality and safety management services on company’s behalf.
To establish a legal person company, numerous documents relating to quality management and safety surveillance are required in order to comply with the requirements of the Japan PMD Act. Moreover, company must employ specialized staff with sufficient experience in medical device safety management. Thus, preparation time and high costs must be considered.
The second method does not require the qualification of a Japanese legal person, nor does it require high expenses to obtain the MAH. It used to be most common method exercised by foreign manufacturers. However, this Japanese domestic company shall have sole authority and product ownership making it difficult for foreign manufacturers to develop their own sales channels and business strategies.
The third method allows foreign manufacturers to quickly enter the Japanese market through the DMAH. To foreign companies, it is a safeguard being able to control and lead domestic sales strategy and expand sales channels to their best interests.
Clarification of DMAH selection under the “Foreign Special Case Recognition Policy”
After revision of PMD Act in April 2005, “Foreign Special Case Recognition Policy” allows foreign manufacturers to select a legal representative in Japan, a DMAH, if the company is not established in Japan.
Only maintenance fee is required to be paid to the DMAH. The time and financial considerations can be reduced significantly compared with setting up a corporation in Japan and applying for the MAH. Through the DMAH which is familiar with the Japanese medical device regulations, foreign manufacturer’s registration application, obtaining product licenses, and import procedures, product packaging label storage, shipment, and after-sales quality and safety management, the complete process can be efficiently completed. DMAH also serves as a communication bridge between Japan's inspection units and foreign manufacturers. Choosing the right DMAH is necessary to avoid leakage of confidential information of product and trade. This is currently the preferred method for European and American companies.
Figure 2. The registration process via DMAH
Note1: Qualifications to obtain MAH
Must employ three specialized personnel experienced in medical equipment
1. General Marketing Compliance officer
2. Quality control manager
3. Safety control manager
Figure 3. The responsibility of Quality control and safety control.
Note 2: Qualification for Japanese Medical Device Business Stakeholder
Table 2. The qualification for Japanese medical device business stakeholder
* Those with Manufacture and Sale License must not manufacture medical device or sell medical device;
* Manufacturing license is required for manufacturing medical equipment;
* Sales license is required for selling medical device.
DMAH maintenance fee per month
JPY 100,000- JPY 500,000
3%-10% of total sum of import invoice
1. Taiwan External Trade Development Council(TAITRA)水五金產業聚落創新升級增商機
2. カラー図解 よくわかる薬機法 医療機器/体外診断用医薬品編
3. 厚生労働省Ministry of Health, Labour and Welfare官方網頁