Medical Devices Other

The new regulations (after 25th Dec, 2014) can be summarized as follows.

Application Procedures (Agency service is available.)

  1. Application to positive list

  2. Issuance of Yakkan certificate

  3. Application for approval and verification

Manual Documentation (Simplified procedure service is available.)

  1. Documentation of GVP manual for medical device

  2. Documentation of GQP manual for medical device

  3. Documentation of QMS manual for medical device

Consultation Services

  1. Consultation on new medical device

  2. Consultation on documentation of HP in compliance with pharmaceutical law

  3. Consultation on documentation of product standards or quality standards

  4. Consultation on CE certification

  5. Consultation on application to MFDS

  6. Consultation on operation both for ISO13485 and QMS regulations

  7. Consultation on reclassification of decorative color contact lens into medical device (including application processes)


  1. Investigation of medical device classifications

  2. Investigation of GQP of foreign manufacturing (field investigation)

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(9 AM-6 PM, Mon to Fri)