The new amendment to the Pharmaceutical Affairs Law was enforced in April 2005, and for the Designated Controlled Medical Devices, certification (NINSYO) system is implemented.
Along with implementation of it, our company provides representative service
for certification. Business contents are as follows. .
ESelection of registered third party certification bodies
EDocuments preparation of medical device application for certification
ENegotiation with registered third party certification bodies
EConsultation for conformity certification criteria
EPrior confirmation of certification criteria compatibility
Our company conducts the business concerning conformity to the Designated
Controlled Medical Devices. We can check the conformity to the certification criteria in advance (Charged, however it is free of charge in the customers to whom the certification
consulting was requested), and you can go forward application for certification
Please find out our fast service as your first foot step.