Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
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Source for The Enforcement Regulations in English - Article 228-20
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Choi Kyoung-Ho
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Medical Devices in Japan - Conformity of QMS to ISO 13485
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v9991
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Looking for English Copy of MHLW 169 regulation
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JeantheBigone
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GHTF Incidents - What does unlabeled and labeled mean?
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mylenerr
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Scope change in Japan - Class I disposable medical devices
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smartinez
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Are English translations required for Japanese Certs
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shimonv
shimonv
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Request for Information; Application for Accreditation
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bender991
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JIS T 1115 Comparison (Japan Medical Device Standard)
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QM Becky
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Japan's Definition of Should and Shall
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Ajit Basrur
Ajit Basrur
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UDI requirements vs Japanese Barcode Marking guideline
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miken99
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Does Japan accept the Bracketing Approach for Process Validation
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redmonkey2
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Japan MHLW Ordinance No 94. (QMS structure Regulation)
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Marc
Marc
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Content of an IVD Technical Dossier to Register a Device to Japan
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Pythagore
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IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law
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2
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esh14
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How does Japan PMDA classify Medical Devices - Classification Guidelines
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woudeniv
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