Tag Archives: Japanese medical device quality systems

Devine Guidance

MHLW MO 169 – Chapter 4 – Manufacturing Control & Quality Control

By Dr. Christopher Joseph Devine
No Comments

Similar to other devices being shipped into Japan, the Japanese equivalent of a technical file is required for devices containing a derivative of biological origin.

Similar to other devices being shipped into Japan, the Japanese equivalent of a technical file is required for devices containing a derivative of biological origin.

Continue reading