News: GMV G Medical Innovations Holdings Files For Offering Of 1.4 Million Adss, page-533

Continue with this morning's unfinished searching and checking (on chinese platform), here are some new bits that i came across:
Still per my previous post (https://hotcopper.com.au/threads/gmv-the-future.4810666/page-348?post_id=39660474) for further discussion below:

The main focus was on the 4 medical products that were appeared on the above Official Notices from Guangdong provincial CFDA (Notice No27/No55 and No54 from their website) that are also the products picked from/appear on the "Green Channel" list.
They are:
#11 on the “green channel” list - "Newborn Jaundice Screening Mobile Phone Software"/ "新生儿黄疸检测手机软件";
#16 on the “green channel” list - "Upper limb rehabilitation training system"/ "上肢康复训练系统";
#20 on the “green channel” list - "Medical smartphone case"(Prizma)/ "智能手机壳";
#24 on the “green channel” list - "Ultrasound scoliosis assessment system"/ "超声脊柱侧弯评估系统".

Obviously there were other non-green channel listed medical devices also appeared on the above official notices that were through the same "supervised spot check/testing" procedure too along with the green-channel-listed medical devices. Some of them might also have got the CFDA approval already (e.g. #3 non-green channel listed product in the table of Notice No27/No55), but their approval might not be of much interest here timeframe wise as we don't know how long they had already been waiting before getting into this final stage "supervised spot check/testing" (nonetheless we know at least that from the time they appeared on the Notice till they got approved, it can be as quick as approx 2 months!).

We now know that the #11 green-channel listed product-"Newborn Jaundice Screening Mobile Phone Software"/ "新生儿黄疸检测手机软件" (first got on the list in 02/2017) actually got their CFDA certificate at the end of Jan 2019 (http://www.ctoutiao.com/1382650.html) after the product appeared as #2 on the official notice No27 dated 07/12/2018 (http://mpa.gd.gov.cn/zwgk/gzwj/content/post_1841382.html). So the overall waiting time was shy of 2 years, and it took less than 2 months once it entered into the final stage "supervised spot check/testing" as announced in the notice No27. (the actual time/period of conducting this final onsite testing as announced by No27 actually took place just a week later right after the announcement and the testing lasted approximately ONE month as clearly indicated in Notice No55 (http://mpa.gd.gov.cn/gkmlpt/content/2/2465/post_2465736.html)).

Interestingly furthermore, it looks like the #24 green-channel listed product- "Ultrasound scoliosis assessment system"/ "超声脊柱侧弯评估系统" (first got on the list in 06/2018), which appeared as #4 device together along with Prizma as #3 device on the table in the official Notice No54 dated 14/05/2019 (http://mpa.gd.gov.cn/gkmlpt/content/2/2465/post_2465738.html), most probably also got approved by the CFDA Guangdong in June 2019 (http://www.most.gov.cn/bszn/new/rlyc/jgcx/201907/t20190709_147573.htm, #65 in the published table/page dated 09/07/2019, and looks like it is a project of national importance from its website). (can be 100% verified by calling its company maybe - "广州中慧电子有限公司" though not directly relevant to Prizma). If so the total waiting time is just ONE year and it only took some ONE month after it entered into the final stage "supervised spot check/testing" as announced in the notice No54. (the actual time/period of conducting this final onsite testing as announced by No54 actually took place just a week plus after the announcement date and the testing lasted/completed in approximately two to three weeks as clearly indicated in another separate official Notice dated 28/06/2019 (http://mpa.gd.gov.cn/gkmlpt/content/2/2525/post_2525523.html).
The above also means that the final onsite "supervised spot check/testing" also already completed on Prizma in early June 2019 (together with the above device #24 in the same group) as announced in the above separate notice (http://mpa.gd.gov.cn/gkmlpt/content/2/2525/post_2525523.html). Which coincide/correlate a bit with the Company's Update dated 30/07/2019 in CFDA part:

"Further the Company is very pleased to advise it has formally received notification that is passed allrequirements of the NMPA during the regulators mid-term auditing process, being a key milestone in theNMPA approval process that limited other trial peers passed with ease. "

Yet may still have some “rectification” work to catch up (also indicated in the Company Update, such as: in "temperature" as well as in SPO2 biometric capabilities etc.) in order to be able to fit into the eventual “Pass after rectification” category like some of the other approved devices. Of coz again just abit of my educated guess here. As for the NMPA nominated PI to the Prizma project, my understanding is (might be wrong!) it is a new mechanism that was recently introduced by NMPA in order to track/trace and communicate effectively throughout the whole lifetime of the licensing of each medical devices. (http://mpa.gd.gov.cn/xwdt/zjdt/content/post_2577846.html).

no luck in finding info about the approval status of the #16 green-channel listed product, will keep trying.

Again all the above is just to help clarify a bit around CFDA/NMPA, and imho only so pls always dyor. (can't change anything and hope there will be more company updates coming!).

GLTAHs!