Pmda - Pharmaceuticals and Medical Devices Agency

Reviews and Related Services

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