Japan - Medical Device Classification for Autoclave Tape

[AJayC]

Does anyone know if in Japan...
1) If Autoclave Indicator Steam Tape is considered a medical device; if yes what is the Class? (I am assuming Class I)

2) If a medical device, what is the Japanese Medical Device Nomenclature (JMDN) code?

Thank you

 

[Ajit Basrur]

Did you contact the PMDA ?

 

[Ronen E]

Does anyone know if in Japan...
1) If Autoclave Indicator Steam Tape is considered a medical device; if yes what is the Class? (I am assuming Class I)

2) If a medical device, what is the Japanese Medical Device Nomenclature (JMDN) code?

Thank you

Hi,

Perhaps this thread might help:

How does Japan PMDA classify Medical Devices - Classification Guidelines

Cheers,
Ronen.

 

[AJayC]

"Autoclave Steam Indicator Tape" is not a medical device in Japan per Japan's PMDA.
PMDA is Japan's version of the FDA.

 

[Ajit Basrur]

Thanks for coming back.

Is your response after confirming that the "Autoclave Steam Indicator Tape" is not a medical device ?

 

[AJayC]

Yes

I contacted Japan PMDA, and they confirmed that the Autoclave Steam Indicator Tape is a not considered a medical device in Japan.

 

[Marc]

Thanks for letting us know! We appreciate it!