Considerations and Resolutions for New Global 2020 Medical Device Regulations
One of my strongest interests this year, was to determine where the complementary “medical” device industry was headed. As you know from my articles following the 2018 Med-Week Congress the scuttlebutt was all centered around the looming restrictive regulation and certification procedures. The necessity to incorporate that bar code onto each device and related accessory (even cables) meant they would no longer be able to export any device into a country where the device was not registered with the applicable country’s equivalent to the FDA. Nearly all countries have re-investigated existing registrations and many have been completely revoked. Now, a year later there is no more wondering and speculation as the regulations come fully into effect in March 2020. I perceive this restrictive new global legislation as the same kind of financial and power reversal that we saw with the CODEX regulations several years ago that virtually destroyed the homeopathic industry.
In light of the increased complications and costs of registration and ISO certification, it is most interesting – and in many cases distressing – to see how individual companies and organizations are responding to the changes.
It is clear that some of the smaller companies are threatened with virtual annihilation. The loss of any possible international market means they do not have access to the funding necessary for innovation or expansion. The restrictions on what can be claimed as effective for each device is now highly restricted and means that only those accessories directly connected to those claims can be included or sold. We are simply in jeopardy of losing those methods.
Others companies are struggling to come up with procedures that will allow them to maintain their medical certifications. However, for those companies, their market has been reduced to the domestic German market or at best the EU until new registrations can be accepted in individual international countries. Survival with this approach to maintaining full medical and ISO certification, leaves many with questionable survival capability, and these methods also are in jeopardy of being lost.
Of particular note here is the reversal of the registration of BioResonance devices as a medical device by the Chinese FDA. Since BioResonance was used even in hospitals in China this was a major market that financially and politically supported this method. Two of the major BioResonance companies (Med-Tronik and Regumed/BICOM) were both bought out by Chinese consortiums several years ago, and now face a questionable survival without that market.
On a more hopeful and positive front, are the companies who have spent the past year looking at alternatives, options and possibilities. I have more than 45 years of experience and work in this field of complementary medicine. Many times over the years, I have watched the cycles of restriction and “freedom”. And many times over the years, we have had to play “games” of semantics and work around the ever-changing regulations and certifications which attempt to “control” and “restrict” the various applications. Because the complementary medicine field is a Billion-Dollar-a-year industry (just wander around any A4M conference to see that), we threaten orthodox or school medicine in many areas.
With specialized changes to the global legislation and regulations coming totally into effect in March of 2020, we are once again entering an era of restriction – and in some cases destruction – of many of the therapy and assessment methods that previously were considered and ISO-certified as “medical”.
In view of these restriction and certification rulings, many of our complementary device manufacturers have altered their products slightly and opted out of the costly and extremely restrictive medical certification. By becoming “wellness” or “spa” products it is hoped we can salvage and protect the decades of research and application for those methods. We need to support the surviving companies, play with the semantics and determine new ways of presenting these applications (= instead of therapies) and assessments (= instead of diagnostics or evaluations) to our patients.
The downside of all this and the reason I have rambled a bit here, is that due to these changes and the fact that most of the devices now available to us are considered “wellness” devices, we are simply not allowed to make any claims or guarantees concerning healing. All “claims” must fall outside of any medical or healing terminology – semantics I know, but nonetheless the way of the world for now.
And I repeat that this push for these changes to the medical device industry should be viewed in the same light as the regulations called the CODEX introduced several years ago which decimated the homeopathic industry and caused the demise of many long-term and respected homeopathic companies (including Staufen Pharma and Heel). The response to this incredible loss of remedies, manufacturers and suppliers is that many of those remedies have now been digitized. For now, they cannot control the software and again we must all support these few remnants of homeopathy so that the information is not lost forever.
I again turn to the image of the phoenix which arises from the ashes stronger and more powerful. We have long said that Biological or Complementary or Alternative Medicine is truly Energy Medicine. It is the ability to focus the energy for healing and the energetic resonance that makes us successful as practitioners. Already there are organizations in Europe who are turning to this “new” terminology. Perhaps the re-emergence of OIRF in its legitimate non-profit research format can also offer support for the preservation of these methods. But be aware – it behooves us to watch diligently in order to protect those methods we know to be effective.