Is ISO 10993 100% acknowledged in Japan?

C

Combination

#1
Hello,

Could somebody help me:

Is ISO 10993 100% acknowledged in Japan?

I read that there are some differences according to Japanese Guidelines for Basic Biological Tests for Medical Devices and Materials, notification no. 99," (Tokyo: Pharamaceutical Affairs Bureau, Ministry of Health and Welfare, July 27, 1995).

Unfortunately I could not find these guideline in the Internet. Could somebody help me?

Thank you!
 
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E

eyeboat

#3
This is an interesting question, I have been searching for the same answer for some time now. Until recently I could not find an English translation. Today I did and it's attached. Note the translation date. Note also that No 99 has been abolished and replaced by 10993.
 

Attachments

M

MIREGMGR

#4
Our understandings are that the Japanese regulatory guidance on biocompatibility issues is Iyakushin-hatsu #0213001, and that this document refers to JIS T0993-1. The former information agrees with the document-attachment in the post above.


We do not yet know if the JIS "0993" series is a substantially complete and unmodified adoption of ISO 10993 other than the required translation, or instead is based on ISO 10993 but incorporates significant technical differences.
 
E

eyeboat

#5
Our MAH in Japan is not recognizing relevant literature and clinical experience with regard to 10992-1 and is requiring test data. Reports that I have sent have been rejected. Has anyone had this experience?

Our devices are short term duration and contact the eye. The material has been used as permanent implants since the 1950's and in our devices since the 1970's with no adverse reactions.

I would be great full for any comments and insight you may have.

Thanks,
 
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