MORA takes another step toward Canadian Registration!
Recently the Med-Tronik firm underwent their regular ISO audit for manufacture of medical devices under the 13485 medical requirements. Needless to say, they passed with flying colors and copies of the new certificates will be available shortly.
One short note from Mrs. Gaby Alexander at Med-Tronik reads as follows:
“Up until now all our amplifiers including the SuperAmp were regarded as accessories. During our audit that declaration was subject to query by both auditors present and resulted in the fact that the SuperAmp will have to be declared as a “medical device” as well.
This means that a product file has to be created and the regional administrative authority has to do a technical certification . . . Although we are not expecting any problems regarding certification we’re not at liberty to produce, market or deliver the SuperAmp until it has passed.
These devices should be available again in about the next 6 to 8 weeks.
Please give our apologies to your members for the delay in delivery of current orders.”
For their audit this year, Med-Tronik finally was able to include the audit procedures for the CMDCAS certificate – essentially a certification that they meet all the standards of Health and Welfare Canada as a medical device manufacturer. All requirements for this certificate (along with all their other certifications) have been passed with no problems.
It was our intention to immediately proceed with Canadian registration procedures for several of the MORA devices upon receipt of the certification copies and backup paperwork from Med-Tronik. But . . .
Please see Page 23 of this issue for a short explanation of Bill C51 which has recently been introduced in Canada. Prior to introduction of this terrible piece of legislation, we could have gone ahead with all registration procedures without concern. Now, however everything has changed. And to add more oil to the fire, there has been a marked slowdown (even to the point of reaching a grinding halt) in the processing of all existing applications – and that unfortunately includes our existing application for the BioPhoton device.[Update Note from 2023: Although we did achieve full Health Canada registration for the MORA Super Med-Tronik subsequently discontinued manufacture of that device. Health Canada did not accept registration of the MORA NOVA as an updated device. Bill C51 mentioned here was dropped during a subsequent Federal election and was never re-introduced.]
Needless to say we will be monitoring this situation closely. We ask all our Canadian members to participate however possible to help make our voices heard to stop this Bill C51.
An Informational Article for Members
From THE BRIDGE Newsletter of OIRF
Published June 2008
© Copyright 2008, OIRF, BC Canada