Japan MHLW Ordinance 169 2004 Manufacturing Control and Quality Control for Medical Devices, 12/04

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Japan’s Ministerial Ordinance for Manufacturing Control and Quality Control Standards for medical devices and in-vitro diagnostic reagents was published in 2004.

For computer and software topics, refer to:

• Article 2ﾠ Definitions
• Article 24ﾠ Infrastructure
• Article 45ﾠ Validation
• Article 53ﾠ Control of Monitoring and Measuring Devices