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Regulatory Information

Regulations and Notifications

Regulatory Procedures


The guidance below links to the website of the National Institute of Health Sciences.

Other Related Information

Frequently Asked Questions (FAQ)

  1. Application for Product Approval
  2. Acceptance of Medical Device Foreign Clinical Data
  3. Accreditation of Foreign Manufacturers
  4. Master File System

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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Regulatory Information