RE: Medical Devices in Japan and Australia

Mike, For Australia, some of the standards you may wish to check include: Safety - AS/NZS 3200.X.X suite of standards (Approval and Test Specifications - Medical electrical equipment). These are based on the IEC 601-X-X suite of standards. EMC - AS/NZS 2064 (equivalent to CISPR 11 and

Re: Medical devices in Japan

Thanks to everyone who replied on this thread. I've forwarded the responses to the original enquirer and doubtless they will contact anyone who offered further help as they feel appropriate. Regards Nick. At 03:02 +0100 1/8/2001, Nick Williams wrote: I've been asked if I know what the

RE: Medical devices in Japan

Hi Nick, To assist you in determining the applicable standards you should contact a representative from JAAME or MHLW at the following address: Japan External Trade Organization (JETRO) New York Health, Labor and Welfare Department McGraw- Hill Building 44th Floor 1221 Avenue of the Americas

RE: Medical devices in Japan

I too am not familiar with Japan, but I have a few tidbits to share. JAMEI (Japan Association of Medical Equipment Industry) Equipment appears to be approved under the leadership of the Ministry of Health and Welfare. Richard Woods -- From: Nick Williams

RE: Medical devices in Japan

Nick, I have a contact in Japan if you need it. I do know that Japan just approved the 2nd Edition of IEC 60601-1-2 but what I am not sure of is if JTA requires compliance or what the transition date might be. If you would like me to look into this, contact me directly. Best regards, Jim