Service package for Pharmaceuticals and Medical Devices Law

JTP provides total solution for entering medical device market in Japan, from the approval process to the post-marketing support.

Use Case

＜ Endoscopy system ＞

✓ Country of Origin : Germany
✓ Approval type : Pre-marketing approval
✓ Authorization body : PMDA

＜ Ultrasound system ＞

✓ Country of Origin : China
✓ Approval type : Pre-marketing certificate
✓ Authorization body : Registered Certification Body (RCB)

＜ LOR syringe ＞

✓ Country of Origin : Taiwan
✓ Approval type : Pre-marketing notification
✓ Authorization body : PMDA

Market Entry Challenges for Overseas Manufacturers

Japan-Specific Device Classification and the Application Process

Market-entry to Japan’s market got to be a little bit simpler by revising from PAL to PMDL. But still, holding the certain licenses and meeting the Japanese law are required to sell the medical devices in Japan.

Expanding Sales Channels

In Japan, medical device manufacturers do not sell directly their own products to medical institute and go through a medical device dealer to do so. This means that in order to enter the market, foreign manufacturers need to make relationships with medical device dealers.

Operations in Japanese language

All documentation and applications are required to be prepared in Japanese, and communication with all related entities including the dealers need to take place in the local language.

Our Strengths

Comprehensive Set of Licenses

JTP holds licenses of Manufacturer, Marketing Authorization Holders, Retail/Rental License of Specially Controlled Medical Devices and Medical Devices Repair License. JTP is able to offer a full range of services in compliance with the Japan Pharmaceuticals and Medical Devices Law (PMDL).

Extensive Experienced Throughout Japan

JTP has many years of experience throughout Japan in providing support services for medical devices. The services are including installation support, repairs and maintenance, as well as offering a 24/7/365 help desk service.

Connections with Nationwide Dealers

JTP has connections with medical devices dealers from supporting experiences. The connections over 300 dealers nationwide makes developing sales channels for market entry to the manufacturers.

IT Expertise

JTP has many years of experience in the IT outsourcing industry, enabling them to offer high-quality IT support services in such as network construction, big data solutions, cloud computing, and security.

Service Offering Includes Post-Marketing Services

JTP handles all processes to sell the products to medical institutes on behalf of the manufacturers. The one-stop support solution reaches the approval process, the sales channel select and the post-marketing support (repair/check). This service makes your business cost effective by fast and suitable entering to the market in Japan.

These materials provide a following contents to know the details about medical devices in Japan:
– summary of revisions to the Japan Pharmaceutical and Medical Device Law (PMDL)
– information on the classifications related with medical devices, licenses, approval and repairs

more...

Service package for Pharmaceuticals and Medical Devices Law

JTP provides total solution for entering medical device market in Japan, from the approval process to the post-marketing support.

Use Case

Market Entry Challenges for Overseas Manufacturers

Our Strengths

Service Offering Includes Post-Marketing Services

Download materials on the classifications of medical devices and PMDL revision in Japan

References

Medical Devices Approval Process in Japan