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Services

Preparation of approval application and related consulting services | Preparation of license application such as import, manufacture, repair and sales, and related consulting services | Steps towards approval application of medical devices | Preparation for review by the Pharmaceuticals and Medical Devices Agency (PMDA) | GMP/GMPI | Health Insurance Reimbursement Application

GMP/GMPI

MIC prepares documents for GMP including manufacturing and quality control as well as GMPI, and provides related consulting services.

• Preparation of device master file
  Advice for preparation of documents on each product such as device master file, manufacturing method, labeling, wrapping and packaging

• Preparation of Standard Operating Procedures (SOPs)
  Advice on preparation of SOPs in which steps for manufacturing a product and tests for quality assurance are defined to obtain uniform quality.
• Advice on records for manufacturing, import and tests
• Support for internal audit