E
Ethan Loh
Hi,
Anyone know what is the classification (medical device or drug) of blood bag in Japan?
Anyone know what is the classification (medical device or drug) of blood bag in Japan?
The Japan MD classification is a 3 -tier system...general, controlled and highly-controlled, with general being the low risk and highly-controlled, the high risk category.
General MD present minimal potential harm to the user. they are regarded as low-risk and include most non-invasive products, certain invasive products, and reusable surgical instruments. examples include wheelchairs, scalpels, dental drills and wound mgt systems.
Controlled MD are generally diagnostic devices and include both invasive and non-invasive products and medical devices for short-term use. Ex: wound dressings; products that channel and store blood for administration into the body; surgically invasive devices for transient or short-term use; most active therapeutic devices that adminster or exchange energy; and active diagnostic devices that supply energy absorbed by the body(otherthan illumination).
Highly Controlled MD: --are regarded as posing a medium-to-high risk to the user. Devices in this class are used to diagnose or monitor, come in contact with the circulatory or central nervous system, or incorporate medicinal products. Examples include condoms, radiological equipment, surgically invasive devices, blood bags, vascular grafts, bone cements that contain antibiotics, and implantable defibrillators.
I hope this helps.
Regards,
Sreenu
General MD present minimal potential harm to the user. they are regarded as low-risk and include most non-invasive products, certain invasive products, and reusable surgical instruments. examples include wheelchairs, scalpels, dental drills and wound mgt systems.
Controlled MD are generally diagnostic devices and include both invasive and non-invasive products and medical devices for short-term use. Ex: wound dressings; products that channel and store blood for administration into the body; surgically invasive devices for transient or short-term use; most active therapeutic devices that adminster or exchange energy; and active diagnostic devices that supply energy absorbed by the body(otherthan illumination).
Highly Controlled MD: --are regarded as posing a medium-to-high risk to the user. Devices in this class are used to diagnose or monitor, come in contact with the circulatory or central nervous system, or incorporate medicinal products. Examples include condoms, radiological equipment, surgically invasive devices, blood bags, vascular grafts, bone cements that contain antibiotics, and implantable defibrillators.
I hope this helps.
Regards,
Sreenu
Q
qualitystu2012
Can you help me with what a hospital bed would be classified as??
Thank you!
Thank you!
Q
qualitystu2012
Thank you for your input. Now taking that question a step further, would a enclosure bed still be a general medical device or a specified controlled? and is there anywhere I can find guidance on this?
thanks for your help!
jan
thanks for your help!
jan
Z
zhang126
Ministerial Notification No. 112, Appendix Table, No. 678:
Nomenclature of Applicable Medical Devices (JMDN):
Blood sampling device, negative pressure, blood bag
JMDN code
70361000
JIS
T0601-1
GMDN code
70361
Class: 2
applicable Japan industry standards, see
http://www.std.pmda.go.jp/scripts/s...cgi?Sig=1&kjn_no_parm=678;kjn=ninsyou&ID=1678
Nomenclature of Applicable Medical Devices (JMDN):
Blood sampling device, negative pressure, blood bag
JMDN code
70361000
JIS
T0601-1
GMDN code
70361
Class: 2
applicable Japan industry standards, see
http://www.std.pmda.go.jp/scripts/s...cgi?Sig=1&kjn_no_parm=678;kjn=ninsyou&ID=1678
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