Because in order for digital health devices to thrive in the Japanese medical industry,
their medical devices need to pass through a strict review, in which
approval and certification are necessary.
By partnering with us, you gain the confidence and
peace of mind that comes with entering the Japanese
market as a fully compliant medical device.
Our comprehensive consulting services ensure you meet all legal,
safety, and quality requirements,
establishing your reputation and trust
among Japanese healthcare professionals and patients.
Apps and software
supporting doctor's
diagnosis and treatment
Devices for monitoring
patient's health status
Apps and software
for preventing disease and injury
In the digital health space,
technology and services are evolving at a high rate of speed.
Requirements for obtaining medical device manufacturing and manufacturing/sales license
Requirements for obtaining medical device manufacturing and manufacturing/sales license
For Class 1-4 medical devices and program medical devices.
There's nothing
to prepare
on your side
There's nothing
to prepare
on your side
Doctors Hub™ MD supports customers
to quickly enter the Japanese digital health market
by acquiring medical device certification
in Japan on their behalf.
We can promote new medical DX businesses
with an exit strategy in mind
＋
Medical device business licenses acquired by proxy
We extract and network a group of expert physicians who are highly sensitive to digital innovation through our own criteria, and provide medical knowledge to companies in various fields. We support the success of medical businesses and the promotion of full-fledged digital health by combining "doctor network" and "technology."
We provide digital health planning and development support services, "Doctors Hub™", digital health marketing and distribution support services, "Doctors Next", and medical collaboration-type online medical support services, "Doctors Station", etc., by utilizing a network of active expert doctors based on our own guidelines.
We are professionals in obtaining medical device approvals and certifications. We have the know-how for all processes related to medical devices from Class I to IV, including program medical devices. We also have the registration as a manufacturing plan for manufacturing medical devices and the approval as a manufacturing and sales plan for providing medical devices to the market.
*Expert Doctor: A network of physicians with top-class clinical experience and achievements
who have a proactive attitude towards digital health and medical digital transformation (DX).
Over 700 specialists are participating.
Program medical devices are defined as programs (software) that have a purpose as medical devices and have the potential to affect the life or health of patients (or users) if they do not function as intended.
For example, the following medical devices are considered program medical devices:
(1) Medical devices that use artificial intelligence (AI).
(2) Medical devices that use machine learning (ML).
(3) Medical devices that use big data.
This is because Doctors Group has the manufacturing and sales business license and the manufacturing business license, and has the know-how to obtain approvals and certifications for a wide range of medical devices.
The approval review for program medical devices is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), an independent administrative institution under the jurisdiction of the Ministry of Health, Labour and Welfare. PMDA conducts the review based on the following review items to ensure the safety and efficacy of program medical devices:
Product safety
Product efficacy
Product instructions for use
Product and quality management system
The period of time required for the approval review of a software medical device varies depending on the class, but generally takes several months to several years. The review period varies depending on the product specifications, etc.
If you consult with Doctors, we will conduct a hearing on your current review and preparation status and your internal organization, and then we will propose a specific range of assistance that you need.
The steps required to obtain approval vary depending on the product. Therefore, we will conduct a hearing on your current preparation status, and then we will reorganize the necessary steps and propose them to you.
If you are not sure if the digital health service you are developing is a software medical device, please feel free to consult with Doctors.
Sanyaku is a position that a company that manufactures and sells medical devices is required to appoint by law. It refers to the three people: the general manager of manufacturing and sales, the domestic quality management operation manager, and the safety management manager. Under the following requirements, Sanyaku assumes each of their roles.
General manager of manufacturing and sales:
Has practical experience in the manufacturing and sales of medical devices,
Bears full responsibility for the manufacturing and sales of medical devices.
Quality assurance manager:
Has practical experience in quality assurance of medical devices,
Bears responsibility for safety management of medical devices.
Safety management manager:
Has practical experience in the safety management of medical devices, and is responsible for the safety management of medical devices.
If you use Doctors Hub™ MD, you can use Doctors Group's licenses, so you do not need to select or hire the above people.
Yes, we can. Contact us and let's first learn more about your medical device.
