JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels

[HelviReg]

Hello everyone,

I am currently seeking information about labeling regulatory requirements in Japan and I've just come upon the JIS T 0307:2004 which is the corresponding standard to ISO 15223:2000 (Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied)

My question is, can we use JIS T 0307:2004 symbols as REF or SN on a label without translating their meaning in japanese (on the same label) ?

The RA team for which I work assures that everything must be translated, but with this standard, I'm not so sure any more .

Thank you very much for your help,

Vivien

 

[Ajit Basrur]

<snip> I am currently seeking information about labeling regulatory requirements in Japan and I've just come upon the JIS T 0307:2004 which is the corresponding standard to ISO 15223:2000 (Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied)

My question is, can we use JIS T 0307:2004 symbols as REF or SN on a label without translating their meaning in japanese (on the same label)? <snip>

Welcome to the Cove, Vivien

The JIS T 0307:2004 is "identical" to the ISO 15223 as per http://www.webstore.jsa.or.jp/webstore/Com/FlowControl.jsp?lang=en&bunsyoId=JIS+T+0307%3A2004&dantaiCd=JIS&status=1&pageNo=0

With regards to not using the Japanese tranlation, you could check with JSA at the below address :

Mita MT Bldg., 3-13-12 Mita, Minato-ku, Tokyo, 108-0073, Japan

Probably some members may chip in having info on this.

Thanks for your question, Vivien

 

[HelviReg]

Thank you Ajit for your prompt answer !

I'll try to get in touch with the JSA.

In the meantime, any info about using these symbols on a japanese label would be appreciated. I'm quite frustrated while looking at our enormous label wherein Serial Number and Reference are translated !

Vivien