Global Regulatory Pulse

Focus on Japan Series: Part I – Important Factors for Medical Device Development in Japan

In Asian Market, Regulatory by Chikako Kitayama and Kei Yoshikawa

Throughout the coming weeks, NAMSA’s Japanese medical device development experts will discuss a variety of regulatory topics related to Japan’s unique product development and manufacturing landscape. This series is intended to provide helpful information and best practices that lead to successful device operations in this quickly growing device marketplace.

In Japan, a medical device manufacturer and/or distributor who has responsibility of a medical device is required to obtain a license referred to as a “Marketing Authorization Holder,” or MAH, in order to distribute or manufacture a product. Specifically, an MAH refers to the party that is responsible for not only medical device distribution, but also a device’s quality assurance and safety management processes and programs.

The Ministry of Health, Labor and Welfare (MHLW) oversees MAHs and provides specific requirements for such entities. Below is a brief outline of important considerations for manufacturers wishing to obtain an MAH in Japan.

I. Categorization of MAH

There are three categories pertaining to manufacturers who seek to obtain a Marketing Authorization Holder designation, which are dependent on a company’s medical device classification. (For further information on Japanese medical device classification categories, please click here to read our previous blog on this topic.)

MAH Category Scope
1st class (Dai 1 syu) All Medical Device Classes (Class I, II, III IV)
2nd class (Dai 2 syu) Medical Device Classes I and II
3rd class (Dai 3 syu) Medical Device Class I

It is important to note that an MAH is required to have a corporate legal office located in Japan. However, if an organization does not plan to establish a legal branch in Japan, a device firm may identify and obtain a Designated Marketing Authorization (D-MAH) contact, allowing this individual to operate – and have the same responsibilities – as an MAH.

II. Submission to Regulatory Authority

Once a device firm has confirmed their classification category, they must submit an MAH application to the nearest prefectural government office. Following, the local regulatory authority will conduct an onsite audit and review documents to determine if the applicant would satisfy the requirements of the Japanese Quality Management System (QMS) and Good Vigilance Practices (GVP). If obtained, the MAH license is valid for five years, and must be renewed every five years following.

III. Identification of Key Administrators

Japanese Ministerial Ordinances require an MAH to identify key managers that will oversee certain responsibilities, or “San-Yaku” in Japanese, meaning “three key administrators.” These key roles are:

Title Key Role
General Marketing Supervisor Supervises the duties, and bears responsibilities, of manufacturing control and quality control, such as decisions related to the release of products.
Domestic Quality Assurance Manager Manages and is responsible for the Quality Assurance Division.
Safety Manager Manages and is responsible for the Safety Assurance Division.

Hiring these key personnel can sometimes pose a challenge for Japanese manufacturers due to strict eligibility requirements, such as those related to academic backgrounds and occupational experience. However, these challenges are lessening slightly since the latest Pharmaceutical and Medical Device (PMD) Act became effective, partially lifting stringent rules, and allowing for some key positions to be served concurrently.

Examples pertaining to the various MAH classes include:

  • All Classes: The General Marketing Supervisor may also serve as the Domestic Quality Assurance Manager.
  • Third Class: One individual may serve in all three key manager roles.
  • Second Class: The General Marketing Supervisor can serve as the Safety Manager only when the General Marketing Supervisor does not serve as the Domestic Quality Assurance Manager.
  • First Class: The General Marketing Supervisor may not serve as the Safety Manager. Therefore, for Class I and Class II MAHs, an organization would be required to employ at least two personnel to fulfill this requirement.

The above is only a snapshot of important business factors for Japanese medical device manufacturers. For our next “Focus on Japan Series,” we will discuss D-MAHs and how to successfully register these types of businesses in Japan.

If you’d like to further discuss the Japanese medical device marketplace with our experts, please email us at communications@namsa.com to schedule a complimentary consultation.

 

Authors:

Chikako Kitayama currently serves as Medical Research Manager for NAMSA-Japan.

Kei Yoshikawa serves as Medical Research Manager at NAMSA's Japan location.