Mdits.

Our misson & policy

MDITS Consulting Co., Ltd. is a company that provides specialized consulting on the Pharmaceutical Affairs Law and various regulations to help solve corporate problems and issues, and leads to the creation of new business concepts and smooth operations.

Our greatest hope is to have health, a healthy body and a calm mind. Our responsibility is to ensure and support that as many people as possible who use your medical devices and health equipment can spend longer and more comfortable lives with a peaceful mind through our various services, such as medical device regulation consulting and obtaining pharmaceutical approval.

Through constant challenges and efforts for this responsibility, we believe that we can achieve symbiosis with the global communities together with our clients who increasingly require our support and service, and also our clients who become our supportive advocates and followers.

★Our Consulting Service & Supoort

Consulting Packages

 ⇒ More Detail

★Medical Device Regulation Consulting

・Pharmaceutical strategy consulting for medical device product introduction.

・Consulting for new establishment of medical device manufacturing and sales, and manufacturing.

・Applicability survey and confirmation service for medical and non-medical devices.

・MD Classification survey, application method confirmation service, etc.

・Application, obtaining approval, strategy and planning to market launch, progress support.

・Pre-review and amendment proposal service for draft application documents created by clients.

・Pre-consulting for authorities, support for various interviews.

・Consulting for domestic and overseas pharmaceutical affairs.

 (Annual & spot consulting, Regulation educational training support (including visiting seminars)), etc.

・Others

★Medical Device Application & PMS Service

・Making support for domestic and overseas regulatory applications.

 (e.g. North America, South America, Asia, Middle East Asia, Europe region, etc.)

・Consulting on post-marketing safety measures for medical device.

・Consulting on medical device insurance application.

・SHONIN, NINSHO Application Dossier build up service.

・Quality managemant system build up service.

・Others

★Other Regulation Support

・Designation consulting, designated by the Measurement Law.

・Designation consulting, type approval support.

・Application support for Radio Law and Electrical Appliance and Material Safety Law (PSE)

・TODOKEDE Documantation making up service.

・Testing site arrangement, biological safety, cemical safety, static testing, etc.

・Overseas implimented testing report evaluation.

・Nortified Body, PMDA application support.

・Others.