Medical Instrument Manufacturers in Ayabe, Japan

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Gunze Medical Division

Ayabe, Japan

Manufacturer

Gunze medical division manufacturing bioabsorbable devices such as sutures, artificial skin and artificial dura mater.

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Business types in Ayabe

Manufacturer 1

Regulation in Japan

Regulator: Ministry of Health, Labour and Welfare (MHLW) with the Pharmaceuticals and Medical Devices Agency (PMDA); Registered Certification Bodies for certification

Japan classes devices I-IV: Class I notification, many Class II/III third-party certification, others MHLW approval after PMDA review, always via a Japan-based MAH.

From the sourced PMD Act entry, checked 29 October 2026. General information, not legal advice. Requirements for Japan · All medical certifications