J-Sol Medical Chiba Plant
A new medical device manufacturing plant of
J-Sol Medical, which was born in 2022.
J-Sol Medical Chiba Plant has established an integrated production system covering design, development, manufacturing, inspection, and storage.
The Chiba Plant will further promote our one-stop solution services and, together with the Tokyo Head Office Plant, will flexibly fulfill various customer needs.
Plant Functions and Features
clean roomClean room with air cleanliness class 1,000
Our production capacity has been greatly increased by operating together with the Tokyo Plant.
The Class 1,000 (ISO Class 6) clean room also enables us to handle implants and other products that require manufacturing operations in a higher cleanliness space.
Sterilization equipmentSterilization equipment indispensable for the manufacture of sterilized medical devices
We have introduced an ethylene oxide gas sterilizer (EOG sterilizer) with a large capacity of 1,710L and inner chamber dimensions: W670 x H1,600 x D1,600 (mm).
Sterilization of a wide variety of disposable products is possible according to the needs of our customers.
Storage and inspection areaMedical device storage and inspection area designed for temperature control
Products are stored under thorough hygiene control until shipment. The medical device storage warehouse, including the first and second floors, is approximately seven times larger than the Tokyo head office plant, and the warehouse area is designed to enable the control of temperature required by customers from -20°C to 30°C. The Chiba Plant can now handle large medical devices and large volumes of products. A dedicated warehouse building is also available.
Service entranceLarge transport vehicles can enter directly through the loading entrance
The area in front of the loading entrance is large enough to accommodate large vehicles, allowing many loads to be carried in at once.
The enlarged loading entrance allows pallets to be accepted as it is.
Roof and ShuttersWithstands inclement weather
Roof and shutters at the loading entrance
The unloading space at the loading entrance is roofed so that operations can be carried unaffected by weather conditions, thus ensure the safety of the products and workers.
Office AreaUnlike the factory area, the office area is a space where employees can relax
The office area was designed with a wood tone base so that factory employees can spend their time comfortably, resulting in a warm and relaxing space that resembles a wooden house.
J-Sol Medical one-stop solution
Three services that realize our one-stop solutions
01
Development and Manufacture of Medical Device
We have been developing and manufacturing our own products including OEM since 2015.
We provide one-stop solution services that support all processes from specification determination and product prototyping to manufacturing and shipping through our experiences and technologies.
Coordinates all processes from development to market delivery
02
Regulatory Solutions
Since our establishment, we have been providing import approvals for many of the latest medical devices from overseas and a wide variety of regulatory consulting services.
We have the know-how to solve various problems that arise when our clients enter the medical device industry.
In particular, we have extensive experience in QMS audits, and offer optimal solutions for customers who have difficulty in preparing SOPs.
Typical Solutions
- Handling of medical devices up from Class I-IV（Licensed Class I Marketing Authorization Holder）
- Extensive experience in QMS support（e.g., support for QMS establishment when overseas medical device manufacturers entered the Japanese market）
- Support for insurance reimbursement of C1 (new function) classification
03
Import Approval and Marketing Authorization Holder Service
More than 25 years of experience
We have more than 25 years of experience in import approval and Marketing Authorization Holder service for foreign medical devices, and have imported many of the latest medical devices.
We are licensed Class I Marketing Authorization Holder and are able to handle all medical devices from Class I to IV.
Since we have manufacturing facilities (Tokyo Head Office and Chiba Plant) registered as Medical Device Manufacturers, our strength is that we can provide integrated services from importation to quality inspection and shipment to the market for foreign medical device products that have been approved and certified in Japan.
Building Outline and Business License
Location 193-27 Ozeki, Yachimata City, Chiba Prefecture, 289-1142 Japan
Total floor area 837.95m2
Licensed for
- Medical Device Manufacturer
- Highly Controlled Medical Device Distribution/Lease
- ISO 13485 certification
Access
- Tokyo Plant
- Chiba Plant
