Scope: |
This ESSENTIAL describes the regulatory requirements of medical devices in Japan, based on the
- Act on Pharmaceuticals and Medical Devices" (PMD Act)
- Information provided by the athorities MHLW and PMDA
Health products are classified into four risk classes, according to the risk associated with their use.
Class I (extremely low risk) - General MDs
Class II (low risk) - Controlled MDs
Class III (medium risk) - Specially Controlled MDs
Class IV (high risk)- Specially Controlled MDs
Not in scope of this CRF:
- In-Vitro Diagnostics (see: ESSENTIAL JPN In-Vitro Diagnostics)
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Legislation in force: |
Short name: Act on Pharmaceuticals and Medical Devices" (PMD Act)
Content (Excerpt):
Chapter V Marketing and Manufacturing Businesses for Medical Devices and In-vitro Diagnostics
Section 1 Marketing and Manufacturing of Medical Devices and In-vitro Diagnostics(Articles 23-2 to 23-2-22)
Section 2 Registered Certification Bodies (Articles 23-2-23 to 23-19)
Chapter IX Handling of Pharmaceuticals, etc.
Section 5 Handling of Medical Devices (Articles 63 to 65)
Chapter XIII Supervision
Article 69 - On-Site Inspections
Chapter XVII Penalties (Articles 83-6 to 91)
Details of duties of Marketing Authorization Holders regarding manufacturing control and quality control of products.
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