Tag Archives: MHLW MO 169

Devine Guidance

MHLW MO 169 – Chapter 4 – Training

By Dr. Christopher Joseph Devine
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There are specific training requirements associated Article 77 to ensure personnel have specialty training; ensure that this training is well documented, including records and a well-written procedure.

There are specific training requirements associated Article 77 to ensure personnel have specialty training; ensure that this training is well documented, including records and a well-written procedure.

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Devine Guidance

MHLW MO 169 – Chapter 4 – Testing

By Dr. Christopher Joseph Devine
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If you are manufacturing a biological-origin component, make sure the test procedures employed are documented (in writing) and test methods validated. If you are purchasing the component of biological origin, it is imperative the suppliers comply with Article 76.

If you are manufacturing a biological-origin component, make sure the test procedures employed are documented (in writing) and test methods validated. If you are purchasing the component of biological origin, it is imperative the suppliers comply with Article 76.

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Devine Guidance

MHLW MO 169 – Chapter 4 – Infrastructure

By Dr. Christopher Joseph Devine
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The Japanese regulatory authorities take seriously the need to adequately identify and control medical devices that contain a biological-origin component, requiring establishment and validation of a cleanroom/controlled environment for manufacturing activities.

The Japanese regulatory authorities take seriously the need to adequately identify and control medical devices that contain a biological-origin component, requiring establishment and validation of a cleanroom/controlled environment for manufacturing activities.

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