Good morning RAPpers
https://*********.com.au/resapp-take-part-german-digital-health-program-secures-tga-approval/Nice!
Now that we have country of origin approval, I'm expecting an announcement to pop any day (next week?) regarding a Chinese collaboration agreement between Ping an and ResApp (Ping an - should be the most likely candidate) for the commencement of a study on their home soil in order to facilitate - National Medical Products Administration (NMPA) (formerly China Food and Drug Administration or CFDA) approval. It'll be interesting to see if just a pilot study is required or a full scale study to test the accuracy etc. Either way the study won't last long as there is high volumes of patients who come in with respiratory ailments. The need for such a tool that we possess for China is great as they rely heavily on online consultations. There is no other means of accurately diagnosing 30 to 40% of patients who seek a diagnosis via a telehealth consultation at this stage without any additional hardware. Our technology will be game changing to a company like Ping an and if they are keen I'm sure they will find a way to expedite the case so we are not waiting around for ages to obtain NMPA!
In saying the above the Chinese have been streamlining their approval process. Read the following article to understand what I am talking about:
https://www.google.com/amp/s/www.regdesk.co/an-overview-of-medical-device-regulations-in-china/amp/I particularly like these last two points from the article:
- Clinical Trial Management System
"The new changes also cover the Clinical Trial Management System in China. We learn that for all Class I devices and most Class II devices,
clinical evaluation is not necessary. For Class III devices, exemption from clinical evaluation is a possibility only if the device has a proven record of safety. This is especially important for foreign manufacturers, as it is very likely that clinical data from studies conducted outside of China will be subject to reviewal by the NMPA, unless use of the device is associated with very high potential risk. All high-risk devices and devices used to support or maintain life must be evaluated in China according to the 2018 draft amendment.
- Prioritization of Innovative Devices
The NMPA’s new regulations clearly prioritize innovative medical devices. According to the 2018 draft amendment, foreign manufacturers will be allowed to import innovative devices into China
without having to provide market entry approval certificates from the country the device was manufactured in."
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Now that we have TGA it's all systems go into China.. Remember Tony Keating went to China for business on a few occasions in the past three months...
https://futureiot.tech/ping-an-good-doctor-ushers-in-era-of-ehealthcare-in-guangxi/These one-minute clinics are really starting to gain some traction ResApp's tech will integrate beautifully into their platform..
Ping an the good doctor have over 500,000 online consultations daily!!
https://www.google.com/amp/www.asiaone.com/business/ping-an-good-doctors-revenue-rose-by-1503-yearonyear-in-the-first-half-of-2018?ampOne of the other options is to do this:
http://www.taipeitimes.com/News/world/archives/2016/04/13/2003643865I'm so grateful that I live here in Australia and we don't have these major issues in our health system.. however in saying that the convenience of telehealth is still a necessity in Australia particularly for those time poor families and those who live in rural communities.
ResApp is going to be an absolute game-changer globally in my honest opinion...
Congratulations to all shareholders. Looking forward to a bright future in ResApp..
Hope you all have a fantastic long weekend
Cheers
Red bar
