Statistical data of ISO certified organizations

ISO certification standard

ISO 13485

[as of July 1, 2020]

Hokkaido Hokkaido 1
Tohoku Aomori 0
Iwate 4
Miyagi 1
Akita 3
Yamagata 1
Fukushima 3
Kanto Ibaraki 8
Tochigi 1
Gunma 6
Saitama 13
Chiba 7
Tokyo 37
Kanagawa 6
Niigata 5
Chubu Toyama 1
Ishikawa 3
Fukui 1
Yamanashi 3
Nagano 9
Gifu 2
Shizuoka 11
Aichi 5
Kinki Mie 1
Shiga 0
Kyoto 4
Osaka 10
Hyogo 4
Nara 1
Wakayama 0
Chugoku Tottori 0
Shimane 0
Okayama 4
Hiroshima 2
Yamaguchi 0
Shikoku Tokushima 0
Kagawa 1
Ehime 0
Kochi 1
Kyushu Fukuoka 3
Saga 0
Nagasaki 1
Kumamoto 0
Oita 3
Miyazaki 0
Kagoshima 0
Okinawa Okinawa 0
China 12
Indonesia 2
India 1
Japan 166
Korea,Republicof 6
Malaysia 4
NewZealand 1
Singapore 5
Thailand 2
1 Non-active Medical Devices 63
2 Active Medical Devices(Non-Implantable) 94
3 Active Implantable Medical Devices 1
4 In Vitro Diagnostic Medical Devices(IVD) 27
5 Sterilization Method for Medical Devices 40
6 Devices incorporating/utilizing specific substances/ technologies 1
7 Parts or services 56

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