This year I was privileged to participate in the recent Medicine Week Congress (Nov. 2018) in Baden-Baden, Germany without the responsibility of organizing and hosting a guided tour program. Although I missed sharing the experience with the usual group of inquisitive participants, it was a rewarding and enlightening conference.
It is my pleasure to share a number of important observations and contacts with you that will affect us as we move forward into 2019. These are my own perceptions and educated opinions offered for your consideration. However, so much has changed in Germany over the past 6-12 months, it is almost as if our field of Biological Medicine has been turned upside down. In this Part 1 article I would like to comment on the coming changes to certification and registration of products within our field.
I spent several days in private meetings with device manufacturers and also in wandering the exhibits at Med-Week. Although there seemed to be more participants this year, there were fewer exhibitors. What was more interesting, was those who were not exhibiting as in so many years past. Several instead opted to exhibit at the massive Medica show in Düsseldorf which took place in mid-November. But that “show” is a global trade fair for allopathic and alternative medicine, where they will be seeking new distributors and global trades rather than sales to or education of practitioners.
An obvious aspect within the Medicine Week Congress was that many of the “fakers” and “copiers” are proliferating in Europe, Russia and North America. Now however, we are starting to see a reaction from the so-called orthodox and registration organizations as a result of so much BS mixed in with the legitimate alternative medical stuff. Their response is initiation of major changes to the political, certification and legislative control over Complementary and Biological Medicine.
Whether it is the proliferation of “fakers” and “junk”; the idealistic view of Germany’s alternative healthcare options; or, the strength and effectiveness of the more advanced physicians and practitioners, the result is that we are headed straight into a time of greater restrictions.
In a nutshell, there is new legislation in place regarding the certification and registration of medical devices. I see these restrictions strangling and shutting down the manufacture, development and availability of alternative devices similar to the way the CODEX destroyed the homeopathic industry.
This new legislation is global in application. All devices which are to be sold or used as medical devices, will have to meet the more stringent CE Medical criteria (that’s the electrical standards like UL in the USA) as well as the ongoing ISO restrictions. Every device must be labeled with one of those square barcode thingies.* Each and every accessory connected with that device must then also be labelled with that same barcode. This policy must be implemented by all manufacturers prior to January 2020.*
[QR code (abbreviated from Quick Response Code) is the trademark for a type of matrix barcode (or two-dimensional barcode) first designed in 1994 for the automotive industry in Japan. A barcode is a machine-readable optical label that contains information about the item to which it is attached.].
“So what,” you say? Well the major impact is on importation of devices – and related accessories like probes – into the USA or Canada (or any other country globally). On arrival into your country the barcode will be scanned and all certification information is then accessible to the customs. If the device is not registered with the FDA or Health Canada, then the device will simply be returned to the sender and not allowed to enter.
For those devices already certified in Germany with medical applications (especially the bigger therapy devices), they cannot now say “oops, sorry we really didn’t mean it”, and they will be barred from exporting to any country where it is not “legally” registered. In my opinion this is the death knell of BioResonance, Ionized Oxygen, and almost every other therapy device we have relied on for decades. The FDA (and also Health Canada) will not register these devices as alternative medical devices without huge battles, and the German manufacturers are unwilling and unable to put up the massive amounts of money, time and effort to comply with these overwhelming regulations and requirements.
Already several of our usually recommended device manufacturers are facing the loss of their entire product lines, and massive financial losses. Those companies unprepared for this legislation are scrambling and some are even threatened with closure, since reliance on the sale of small non-medical devices and on the domestic market is not financially viable.
Those companies that have been preparing for this eventuality in advance, have been working out “grey areas” in the regulations and developing alternate devices that can still be marketed. For some this will give them time to readjust for the new market, others are simply not going to make it by relying on sales of smaller devices that fit into the grey area.
And what is this grey area? In a word: “wellness”. By avoiding the medical label and going with wellness, such items as devices and remedies then fall into a category similar to a shaver or electric toothbrush. All of our testing devices for EAV, Vega, AMA, EDS or whatever, will definitely be in this wellness category. All of the smaller therapy type devices such as the small magnetic generators, the FIT 915 goggles, remedy duplicators, remedy software, and so on will also fall into this category. But this is not the heavy-duty therapy that we’ve relied on for current and modern patients – therapies like BioResonance (be it MORA or BIOKAT or BICOM in whatever form), oxygen therapies, homeopathic remedies(!) and so on will no longer be allowed into the USA or Canada. Really scary!
So, my message to you today folks is: Make your decisions now. Many of you have been talking to me about wanting new devices, or replacement devices, or . . . The way I see it now, is that we have a limited short window of opportunity. If you are even contemplating getting a new therapy device, let’s talk and I’ll do my best to steer you to a quality and reliable company. I do not sell devices and I am not a distributor for any company. I cannot and will not handle the sales – on this aspect I am adamant. Thus, I can remain your source for unbiased information and be completely independent to offer my opinion and guidance.
For the record, there are two “new” testing devices I saw while at Med-Week. One is from the LARET Company who came over to our hotel and met with myself and a few colleagues privately one evening. They are also a pharmacy and not only make test sets but can sell and ship them! The test sets are based on the work of Helmut W. Schimmel, MD DDS, and the device is based on his final research using light while testing. This method is of interest to those VEGA-testers among you looking for a method which will test in more detail.
Secondly, there are a series of devices from the MBA Company which are primarily EAV-type devices. They meet all the standards, two of them can also do a form of VEGA testing and they are relatively inexpensive.
In both cases, communication with these companies has been slow and I am still attempting to make arrangements for you to order from them directly. Training in English is very limited for both.