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Support for the acquisition of Medical Device Business License, and the application for Marketing Authorization Holder of medical devices. For customer that would like to manufacture and distribute Medical Devices

Do you have any problems in manufacturing and marketing medical devices?
I want to manufacture and sell medical devices, but I don't know how or where to start with the license application.
I want to develop a medical device business, but I don't know the required preparations.
I want to proceed with the application / authorization, but I don't have time. How can I complete it efficiently and quickly.
Otsuka Electronics can help you with these problems
We will provide information on how to acquire the Medical Device Business License and how to apply for the Marketing Authorization Holder.
We will inform you on the documentation to be prepared.
We will thoroughly review your needs and propose the appropriate application method accordingly.

Examples of other operations that we can support: Providing the formats of the necessary documents, reviewing the completed documentation, implement trial audits, and others.

About manufacturing and marketing medical devices

In order to manufacture and market medical devices, the Pharmaceutical and Medical Device Act has established the approval and registration system, and medical devices cannot be handled without these approval and registration. In addition, in order to distribute medical devices to the market, it is necessary to obtain approval and certification for each product from a Registered Certification Body.

1. Medical Device classification

Highly managed medical device Class IV: Highly invasive to patients, and may be life-threatening if malfunction occurs.
Class III: Devices that are considered to have a relatively high risk to the human body in the event of a malfunction.
Managed medical device Class II: Devices that are considered to have a relatively low risk to the human body even in the event of a malfunction.
General medical device Class I: Devices that are considered to have extremely low risk to the human body even in the event of a malfunction.

As mentioned above, medical devices are classified into Class I to IV according to the degree of risk to the human body, and at Otsuka Electronics, we handle medical devices from general medical devices to highly managed medical devices (Class I to III). We provide consultation support for devices in the Class I to Class III range.

2. About Marketing Authorization for medical device

Type Types of medical devices that can be marketed
First class medical device Marketing Authorization Holder Highly managed medical devices (Class III, IV)
Managed medical device (Class II)
General medical device (Class I)
Second class medical device Marketing Authorization Holder Managed medical device (Class II)
General medical device (Class I)
Third class medical device Marketing Authorization Holder General medical device (Class I)

A "Marketing Authorization Holder" is required to manufacture and market the medical devices.
Otsuka Electronics is a licensed first-class Marketing Authorization Holder.

Scope of licenses acquired (We provide consultation support within the scope of the licenses that have been obtained.)

Type of business Location License number Type / classification
First-class medical device Marketing Authorization Holder Osaka Pref. (Headquarter) 27B1X00055 First class
Medical device manufacturing Osaka Pref. (Headquarter) 27BZ200551 -
Medical device manufacturing Shiga Pref. (Shiga Plant) 25BZ000073 -
Medical device service (repair) Shiga Pref. (Shiga Plant) 25BS080002 Specially-designated medical devices requiring maintenance: Category 2, 4, 8

Non Specially-designated medical devices requiring maintenance: Category 2, 4, 8, 9

3. About approval of the Marketing Authorization Holder for medical device

In addition to license acquisition, approval, certification, and notification must be obtained from each relevant agencies in order to distribute medical devices on the market.
Otsuka Electronics have obtained the approvals, certifications, and notifications that correspond to the classifications of medical devices.

* The support for Marketing Authorization Holder application will be determined once the range of support that can be provided has been identified following the consultation with our representatives, subject to the type of medical device.

Process flow for the support in Medical device business license acquisition and application for Marketing Authorization Holder.

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