http://mpa.gd.gov.cn/zwgk/xkxxgk/ylqx/deltbsp/content/post_2589762.html
http://blog.sina.com.cn/s/blog_bd840b580102yxjb.html
@Idisley, Sorry for the late reply. My heart is broken, and I am too frustrated to reply or post in the last few days. Based on the recent company update, I don’t think we would have NMPA/CFDA approval in a short period of time. And what I found is NOT good news. A new notice was published by Guangdong Province Medicine Administration on 26/08/2019, saying another 4 products entered into the Green Channel (with special approval process and shorter waiting period) after Feb 2019.
There were 10 products that entered into this channel in 2018 and 5 more products in 2019, totally 34 products in the waiting list, (all belongs to Guangdong Type two (means median risk, 3 types in total) Innovative Medicine Devices). Our Prizma Medical Smartphone cover in still in the 20th sorted by the entry date. I have compared this new notice with the Feb 2019/Dec 2018 Notice, the first 29 or 30 products are exactly the same, only adding 4 products after Feb 2019. On the mpa.guangdong website (new official website) they have deleted the previous notice published in Feb 2019 and consolidate as a new and updated list for the new notice. I can only use the 2nd link to show you what it looks like in Dec 2018. And they denied access to the old official website as well.
This means no single one product was granted approval between 10 Dec 2018 and 26/08/2019. And I have called the approval officer’s number to confirm. This time they can recognise I am calling from overseas (I was using my mobile). The answer is silence and no comments. The first product on the list is from Shenzhen Kerui Medical Device Pty Ltd, ref 2016001,
| 深圳科瑞克医疗器械有限公司 | 精子质量分析仪 | 2016001 | 2016年4月26日 |
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Which entered into the green Channel on 26/04/2016. That’s why Brendon told us for some of the products the waiting period could be three years (or more) in the recent annual meeting.
According to a separate report from Beijing, the first Type two innovative medical device in Beijing was approved and entered into the market on 26/08/2018. It took around 18 months from entering into the channel to final approval. And they called this as super fast and efficient. So far in the last 2 years, Beijing is the city that gains most approval around China.
Based on my research and confirmation from the approval officer, our Prizma belongs to Guangdong Type two innovative medicine device. It will be approved directly from the Guangdong province level, NOT NMPA (National level, that is for Type 3 (high risk) and foreign brands. The approval officer advised me that they will NOT issue a separate notice for the approval of a single product (this matches with my research work based on previous approvals). Of course, they will issue a formal notice to the applicant, however it will NOT be published on the mpa website. Only way to check approval, is to search this product from the directory of the official websites (maybe both mpa and nmpa after approval, they are linked and can be directed to further gov website) If you can find this product, it will pop up the approval reference number and other details. If no result, means no approval.
I do believe you are wasting your time to check from the NMPA website for this product’s approval.
On the other hand, whether a new independent investigator was appointed for our company, this kind of news is unlikely to be reported on the official website.
