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Angelababy

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28/08/19

01:56

Post #: 40185103
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Originally posted by Angelababy: ↑
Dearall,

Pieces and bits found from the Chinese websites for NMPA approval. I have tried to ring the officer to ask for 2019's approval last week, no one is answering the land line.

http://mpa.gd.gov.cn/xwdt/sjdt/content/post_2223562.html
广东省医疗器械创新发展持续发力
发布时间：2019-03-14
省创方面，2018年广东省共有踝关节智能康复机器人等10个产品进入第二类创新医疗器械特别审批程序。2018年省局共批准4 个第二类创新医疗器械产品上市，平均技术审评时间为20个工作日、平均补后审查时间为12个工作日，总审评时间共缩短了73%。
　　广东省局将继续实施和完善创新医疗器械特别审批程序，加快第二类创新医疗器械审评，推动医疗器械产业高质量发展。

Pleasesee notice below from Guangdong Provincial Medicine Administration, published on14^th Mar 2019.
”In terms of provincial innovation, 10 products,such as ankle intelligent rehabilitation robots, entered into the specialexamination and approval procedure ( GMV is the first who entered into this “Green Channel” in 2018, ref: 2018001, granted date: 9^th Jan 2018 ) fortype II innovative medical devices in Guangdong Province in 2018.In 2018, the provincial bureau approved the listing of 4 （only 4 products were approved in 2018）type II innovative medical device products, the average technical review time was 20 working days, the average post-supplement review time was 12 working days, and the total review time was shortened by 73%.
The Guangdong Provincial Bureau will continueto implement and improve the special examination and approval procedures forinnovative medical devices, speed up the review of type II innovative medicaldevices, and promote the high quality development of the medical deviceindustry.”

http://mpa.gd.gov.cn/zwgk/xkxxgk/ylqx/deltbsp/content/post_2222230.html
According tothe website above (from Guangdong Provincial Medicine Administration dated 10 March 2019), until 10^th Mar 2019, there are still 30 products that are categorised as Guangdong provincial type II innovative medical devices (Green channel in Guangdong) waiting for approval, (GMV is in the 20^th of these 30 products) , product no. 1 – a product for Spermquality analysis from Shenzhen Kerui Medical Devices who entered into greenchannel on 26^th Apr 2016, ref:2016001, is still waiting forapproval. (more than 3 years now). I tried very hard, cannot find any notices/reportsfor approval in 2019 by Guangdong Provincial Medicine Admin for Type II MedicalDevices.
There were only 4 approvals in 2018.
https://www.prnasia.com/story/224492-1.shtml
Shenzhen, on September 28, 2018, Li Xiting,chairman of Mairui Medical Device Pty Ltd, attended a meeting of the GuangdongFood and Drug Administration, at which he obtained the country first"Class II Medical device Product Registration Certificate" issued byLuo Wenzhi, director of the Guangdong Food and Drug Administration. This time,it is the injection pump, infusion pump and infusion management system ofShenzhen Mairui Technology Co., Ltd., obtained the registration certificate ofthe type two of medical device products issued by Guangdong Food and DrugAdministration, and commissioned Shenzhen Mairui Biomedical Electronics Co.,Ltd. (hereinafter referred to as "Mairui Medical") to produce. Atthis point, the injection pump, infusion pump and infusion management system ofMairui Science and Technology have become the first batch of medical deviceproducts approved and listed in accordance with the pilot work implementation Schemeof Guangdong Medical device Registration system (hereinafter referred to as thepilot work implementation Scheme).
深圳2018年9月29日电 /美通社/ -- 2018年9月28日，迈瑞医疗董事长李西廷出席了广东省食品药品监督管理局会议，在会议上获得由广东省食品药品监督管理局局长骆文智颁发的全国第一张“第二类医疗器械产品注册证”。
此次，是深圳迈瑞科技有限公司（以下简称“迈瑞科技”）的注射泵、输液泵和输液管理系统，获得由广东省食品药品监督管理局颁发的第二类医疗器械产品注册证，委托深圳迈瑞生物医疗电子股份有限公司（以下简称“迈瑞医疗”）生产。至此，迈瑞科技的注射泵、输液泵和输液管理系统成为按照《广东省医疗器械注册人制度试点工作实施方案》（以下简称《试点工作实施方案》）获批上市的首批医疗器械产品。

Expand
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 20^th 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 2^nd 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
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.

Originally posted by Angelababy: ↑
Dearall,

Pieces and bits found from the Chinese websites for NMPA approval. I have tried to ring the officer to ask for 2019's approval last week, no one is answering the land line.

http://mpa.gd.gov.cn/xwdt/sjdt/content/post_2223562.html
广东省医疗器械创新发展持续发力
发布时间：2019-03-14
省创方面，2018年广东省共有踝关节智能康复机器人等10个产品进入第二类创新医疗器械特别审批程序。2018年省局共批准4 个第二类创新医疗器械产品上市，平均技术审评时间为20个工作日、平均补后审查时间为12个工作日，总审评时间共缩短了73%。
　　广东省局将继续实施和完善创新医疗器械特别审批程序，加快第二类创新医疗器械审评，推动医疗器械产业高质量发展。

Pleasesee notice below from Guangdong Provincial Medicine Administration, published on14^th Mar 2019.
”In terms of provincial innovation, 10 products,such as ankle intelligent rehabilitation robots, entered into the specialexamination and approval procedure ( GMV is the first who entered into this “Green Channel” in 2018, ref: 2018001, granted date: 9^th Jan 2018 ) fortype II innovative medical devices in Guangdong Province in 2018.In 2018, the provincial bureau approved the listing of 4 （only 4 products were approved in 2018）type II innovative medical device products, the average technical review time was 20 working days, the average post-supplement review time was 12 working days, and the total review time was shortened by 73%.
The Guangdong Provincial Bureau will continueto implement and improve the special examination and approval procedures forinnovative medical devices, speed up the review of type II innovative medicaldevices, and promote the high quality development of the medical deviceindustry.”

http://mpa.gd.gov.cn/zwgk/xkxxgk/ylqx/deltbsp/content/post_2222230.html
According tothe website above (from Guangdong Provincial Medicine Administration dated 10 March 2019), until 10^th Mar 2019, there are still 30 products that are categorised as Guangdong provincial type II innovative medical devices (Green channel in Guangdong) waiting for approval, (GMV is in the 20^th of these 30 products) , product no. 1 – a product for Spermquality analysis from Shenzhen Kerui Medical Devices who entered into greenchannel on 26^th Apr 2016, ref:2016001, is still waiting forapproval. (more than 3 years now). I tried very hard, cannot find any notices/reportsfor approval in 2019 by Guangdong Provincial Medicine Admin for Type II MedicalDevices.
There were only 4 approvals in 2018.
https://www.prnasia.com/story/224492-1.shtml
Shenzhen, on September 28, 2018, Li Xiting,chairman of Mairui Medical Device Pty Ltd, attended a meeting of the GuangdongFood and Drug Administration, at which he obtained the country first"Class II Medical device Product Registration Certificate" issued byLuo Wenzhi, director of the Guangdong Food and Drug Administration. This time,it is the injection pump, infusion pump and infusion management system ofShenzhen Mairui Technology Co., Ltd., obtained the registration certificate ofthe type two of medical device products issued by Guangdong Food and DrugAdministration, and commissioned Shenzhen Mairui Biomedical Electronics Co.,Ltd. (hereinafter referred to as "Mairui Medical") to produce. Atthis point, the injection pump, infusion pump and infusion management system ofMairui Science and Technology have become the first batch of medical deviceproducts approved and listed in accordance with the pilot work implementation Schemeof Guangdong Medical device Registration system (hereinafter referred to as thepilot work implementation Scheme).
深圳2018年9月29日电 /美通社/ -- 2018年9月28日，迈瑞医疗董事长李西廷出席了广东省食品药品监督管理局会议，在会议上获得由广东省食品药品监督管理局局长骆文智颁发的全国第一张“第二类医疗器械产品注册证”。
此次，是深圳迈瑞科技有限公司（以下简称“迈瑞科技”）的注射泵、输液泵和输液管理系统，获得由广东省食品药品监督管理局颁发的第二类医疗器械产品注册证，委托深圳迈瑞生物医疗电子股份有限公司（以下简称“迈瑞医疗”）生产。至此，迈瑞科技的注射泵、输液泵和输液管理系统成为按照《广东省医疗器械注册人制度试点工作实施方案》（以下简称《试点工作实施方案》）获批上市的首批医疗器械产品。

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