Statistical data of ISO certified organizations

ISO certification standard

ISO 13485

[as of February 8, 2019]

Hokkaido Hokkaido 1
Tohoku Aomori 2
Iwate 4
Miyagi 2
Akita 2
Yamagata 1
Fukushima 5
Kanto Ibaraki 11
Tochigi 7
Gunma 8
Saitama 16
Chiba 8
Tokyo 49
Kanagawa 15
Niigata 2
Chubu Toyama 0
Ishikawa 2
Fukui 1
Yamanashi 1
Nagano 13
Gifu 4
Shizuoka 10
Aichi 10
Kinki Mie 0
Shiga 2
Kyoto 9
Osaka 15
Hyogo 6
Nara 0
Wakayama 0
Chugoku Tottori 1
Shimane 0
Okayama 5
Hiroshima 2
Yamaguchi 1
Shikoku Tokushima 1
Kagawa 3
Ehime 1
Kochi 1
Kyushu Fukuoka 5
Saga 0
Nagasaki 2
Kumamoto 0
Oita 3
Miyazaki 1
Kagoshima 0
Okinawa Okinawa 0
China 12
Indonesia 1
Japan 232
Cambodia 1
Korea,Republicof 7
Malaysia 2
NewZealand 1
Singapore 9
Thailand 3
1 Non-active Medical Devices 78
2 Active Medical Devices(Non-Implantable) 149
3 Active Implantable Medical Devices 1
4 In Vitro Diagnostic Medical Devices(IVD) 50
5 Sterilization Method for Medical Devices 40
6 Devices incorporating/utilizing specific substances/ technologies 1
7 Parts or services 28

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