Introduction to Entering Japanese Medical Device Market

Qualtech has started providing regulatory services for medical device manufacturers who aim for the Japanese market. Taking this opportunity, we would like to provide a brief introduction of what Japanese regulation requires for foreign manufacturers to sell their products in its market. 

Topics to be discussed in this Article: 

     (1) Appointing Local Representative in Japan

     (2) Classification

     (3) Medical Device Nomenclature Name / JMDN Code

(1) Appointing Local Representative in Japan

The easiest way for manufacturers without any legal body in Japan to sell medical devices in Japan is to assign local representative located in Japan. This local representative must hold a license called “Marketing Authorization,” to be able to represent foreign manufacturers and take a responsibility of their products in local market. Having a local representative is one of the most important requirements for foreign manufacturers, unless they have a local subsidiary who has obtained Marketing Authorization.

There are two ways to appoint Marketing Authorization Holder. One is to appoint it as a Marketing Authorization Holder (MAH) and the other is Designated Marketing Authorization Holder (DMAH). The major difference between MAH and DMAH is to whom the ownership of product license goes. If a manufacturer chooses to assign MAH, MAH will be the owner of product license and directly contracting with local distributors. The system of DMAH was introduced much later than MAH by the Japanese government to welcome more foreign-made products. If a manufacturer chooses to assign DMAH, it can be the owner of product license and can directly contract with local distributors, so that they have more autonomy of business activities in the Japanese market.

As a trusted partner, Qualtech Consulting Corporation can act as your DMAH as well as help you register your products in Japan. With our experienced specialists, we can accelerate your global business.

(2) Classification 

In Japan, medical devices are classified based on their risks, from class I (low risk) to class IV (high risk).  Each class has its own registration process as shown in the following table. One of the tricky parts of the classification is some class II devices requires approval from PMDA and some class II device can be certified by Registered Certificate Body (RCB). Especially for class II devices that does not have standards defined, those devices are required to receive an approval from PMDA.

Risk Class	Class Name		Registration Process
Class I	General Medical Device		Notification to
Class II	Controlled Medical Device		Certification by Registered Certificate Body
Class III
	Specially Controlled Medical Device		Approval by PMDA
Class IV

Risk classes are not only one way of categorizing medical devices to meet registration requirements. In Japan, distributors must be authorized by or notified to prefectural government to sell medical devices to hospitals and clinics, and medical devices are also categorized based on requirements for distributors. This is where a different categorization comes in. Some devices categorized under “Controlled Medical Device Requiring Special Maintenance,” no matter what their classes or what their registration requirements are, require their distributor to be authorized to sell medical devices to hospitals and clinics. Any devices that comes under Specially Controlled Medical Device require their distributors to be authorized no matter they are under Controlled Medical Device Requiring Special Maintenance or not.

Risk Class	Controlled Medical Device Requiring Special Maintenance		Requirements For Distributors
General Medical Device	Yes	No	Notification to Prefectural Government
Controlled Medical Device
			Authorization by Prefectural Government
Specially Controlled Medical Device	Yes/No

(3)  Medical Device Nomenclature Name / JMDN Code

            Japanese Medical Device regulation has its own unique system called Medical device Nomenclature Name / JMDN code. This system was incorporated from GMDN（Global Medical Device Nomenclature）to identify all existing medical device in general. For manufacturers to register their products, their products must fit one of the intended uses that is identified by the Japanese Medical Device Nomenclature Name. Any devices that cannot be identified by JMDN code must be consulted with PMDA. With Japanese speaking specialists, Qualtech will present you with the most suitable registration strategy and guide you to join business activities in the Japanese market. 

One of the strengths of Qualtech is, we provide regulatory services in countries of both major markets and minor markets which are expected to experience rapid growth in near future. With our experienced experts and engineers located around world cooperating, we can offer you the most efficient regulatory path to expand your global business with only one window. For further inquiries please contact us via irene@qualtechs.com or ayaka@qualtechs.com.