Regulatory solutions
Since our establishment in 1997, we have been engaged in consulting services related to applications for approval of import medical devices to the Ministry of Health, Labour and Welfare, and have the know-how to solve various issues that arise when small and medium-sized companies enter the medical device industry. In particular, as a licensed Manufacturer and MAH, we have extensive experience in QMS audits, and can provide optimal solutions for our corporate clients who have difficulty in preparing SOPs.
In addition, approximately 65% of medical devices used in the domestic Marketing are imported from overseas due to high barriers in applying for approval/certification, but we believe that many of them can be manufactured domestically. As a one-stop solution company for medical devices, we are able to meet the needs of all types of medical devices.
Support and prepare for approval applications to certifying bodiesFrom the preparation of approval application to certifying bodies required for the sales of medical device to acquisition of approval afterwards, we support them all. |
Support and prepare for applications to PMDAWe provide full-range supports for applications to authorities, from preparing for notification to acquisition of approval afterwards, necessary for the sales of medical devices. |
QMS ConsultingFor those clients involvied in design/development, it is obligated to receive QMS audit from either certifying bodies or PMDA. We help prepare for documents needed for the audit. |
Consulting of pharmaceutical affairs strategyAdvise the most efficient way to enter the medical device market. |
Consulting of testing requirements for medical device evaluationHelp you with the testing requirements for the evaluation of efficacy and safety of medical device. We may also recommend some safety testing institutions. |
Consulting of medical device storageOur warehouse is a Registered Manufacturer class required for storing medical devices. |
Integrated support from application to product storage
As medical device related businesses often require extensive expertise; that is why medical devices related companies are divided into different domains such as companies for consulting for pharmaceutical affairs strategy, companies for preparing applications/ approvals, companies for storing medical devices, and companies for supporting the QMS audit.
We contribute to our customers by providing a total solution for medical devices so that customers can reduce their cost by combing all the operations through our services. Our staff who are fluent in English will support communications with overseas companies and translation for you.
Accomplishment in regulatory assistance
Major achievements (coronary stents, etc.)
Cardiovascular field (major achievements: electrode catheters for the heart, coronary stents, and many others)
Orthopedics (Major achievements: bone cement, vertebral orthopedic devices)
Others (Major achievements: foreign body removal filters, electrodes for electrocardiographs, examination/medical examination gloves)
Cardiovascular field (major achievements: atrial septal puncture needle)
Major Achievements (QMS establishment support for overseas medical device manufacturers entering the Japanese Marketing, support for obtaining business licenses, etc.)
