Prior Certification Representation

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.

  • Selection of registered third party certification bodies
  • Documents preparation of medical device application for certification
  • Negotiation with registered third party certification bodies
  • Consultation for conformity certification criteria
  • Prior 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 promptly.

Please find out our fast service as your first foot step.