GMV The Future, page-348

Hi all, after numerous unsuccessful searches lately tryingto find any new updates through either google or chinese search engines, hereare some interesting bits regarding cfda that I just came across:

As most are in chinese, while can’t translate everything (apology), i’ve translated/google translated some part in detail in order to help the explanation/thinking here:

PRIZMA only needs approval from CFDA Guangdong/Canton province (http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s10803/list.htm)

(they have new website http://mpa.gd.gov.cn/ from March 2019)

Here is the “Green Channel” list for
Innovative Medical Device Special Approval (Guangdong Province, the secondcategory) (http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s10803/201812/362378.htm, as posted before. Will need this table/list to help the below):

G Medical Prizma is #20 on the list:

No. CompanyName ProductName NoticeNumber NotificationTime Remarks

.

.

20-Guangzhou Yimei Innovation- Smartphone case (requires complete product name when registering according to relevant regulations)- 2018001-January 9, 2018 - /

.

.

Here comes interesting bit:

Via https://webcache.googleusercontent.com/search?q=cache:Yq9DFh7rSbAJ:https://www.tianyancha.com/company/3026680756+&cd=13&hl=en&ct=clnk&gl=au

There are two related Notices from Guangdong Drug Admin(CFDA Guangdong/Canton)

1. Official Notice (No55, 2019, issued 15/05/2019) of [Provincial] Guangdong Provincial Drug Administration on the results of supervised spot check/testing of Medical Device Clinical Trials in Second Phase 2018;

(https://news.tianyancha.com/detail/95d0b4808b94dc9ab81079d89c3ffee73b5c042e.html)

Notice#55 were detailed in three parts:

1). General Introduction of the 4 Medical device clinical trials and the relevant institutions that conducted those clinical trials;

2). Any problems found after inspection?
Says No real problem was found in this check/inspection. Except some compliance issues.

3). Processing comments and related requirements.

2. Official Notice (No54, 2019, issued 14/05/2019) of [Provincial] Guangdong Provincial Drug Administration on starting/carrying out supervised spot check/testing of Medical Device Clinical Trials in Second Phase 2019;

(https://news.tianyancha.com/detail/c66c88c3f6d50d5fd8cbfa9634b3aeb88e446d2b.html)

Prompted by the above notices, here is an old official notice that can also be found at CFDA Guangdong’s website which was to announce the start of the testing/inspection of the 4 clinical trials mentioned in Notice No55:

(http://mpa.gd.gov.cn/zwgk/gzwj/content/post_1841382.html)

Official Notice (No27, 2018, issued 07/12/2018) of [Provincial] Guangdong Provincial Drug Administration on starting/carrying out supervised spot check/testing of Medical Device Clinical Trials in Second Phase 2018.

Exactly the same notice format of Notice No55 of 2019 except there were 4 devices in No27/No55, but 5 medical devices in No54.

Interestingly, out of the 4 medical devices listed in Notice No27/No55 (see the table in the bottom of the notice), #1 is listed as #16 in the above official “green channel” list; #2 is listed as #11 in the “green channel” list.

#3 is noted as “Passedafter rectification” in the Official Notice dated 22/02/2019 (http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s8956/201902/363246.htm) which is earlier than Notice No55’s issuing date-15/05/2019;

However, just found out at this point that #4 device in Notice No27 didn’t pass the Quality management system verification as per (http://www.zcqxxx.com/bid/news_418322.shtml). But really don’t think Prizma will be the case considering it’s already passed FDA etc.

The point im trying to make here is the timeframe:

Notice No27 (start the inspection) was issued on 07/12/2018 and initial results Notice No55 issued on 15/05/2019. Approximately less than 5 months if excluding New Year holiday (3 days) and Chinese New Year holiday (approx 7-10 days), with the chance that some devices might be approved/passed earlier as of the device #3 mentioned above.

In short, Notice No54 (where Prizma was in, together with #24 applicant in the green channel list plus other 3 - total 5 devices) was issued on 14/05/2019, hence a reasonable estimate on result issuing time of these 5 devices would be around early Oct 2019 with a good chance to be earlier for certain devices. Just some educated guess here. As usual please always DYOR.

And imho cfda approval can also means little if not nothing to the GMV’s sp unless substantial contracts are landed after the approval. Did notice though G medical attended two largest exhibitions in China one in late last year in Shanghai (International Import Exhibition) and one (bio-med equipments exhibition) mid this year in Guangzhou (from memory sorry) plus attended numerous talks/forums, and Dr Geva seems happy when he's speaking to some news reporters after the events. There is also already an advertising/promoting video speaking fully in chinese re “PRIZMA G2 智能医疗手机壳” in place which can be found at QQ video channel. So hopefully all these effort behind plus those we didn’t see will eventuate real contracts there after cdfa!

Best of luck to all holders especially LTHs!

p.s. (apologies if anything loose in thetranslations)