Dear all, I have to admit that I am frustrated and regret that I did NOT sell at 40c in Oct 2018.
I am going through the NMPA website and checked again for last 12 months' approval list, I cannot find any single one product belongs to Domestic Class two medical equipment. I do believe the below is not the correct website
check for the approval.http://www.nmpa.gov.cn/WS04/CL2177/I rang nmpa office and GDDA (Guangdong Drug Adminstration) and asked for the approval officer's number. Both of the girls passed me the numbers. NMPA, no luck, I rang many times for a few days, no one is answering the phone at all. For GDDA, as they are from the state/province level,I can feel they are easier to be contacted and more friendly. Day 1, last week, a young lady picked up the phone. I expressed my previous concern and asked which website to check for the information. She frankly answered: " I don't know. However you can ring again tomorrow. As my supervisor, the approval officer will be back from business trip tomorrow. He will be able to answer your questions." I forgot about this and got tied up at work. Until yesterday, I rang GDDA again, a middle age man answered my phone and asked me which organisation I am from. It seems that he cannot recognize my Sydney number. This supervisor confirmed that the approval will be still from GDDA, NOT NMPA, although new rules saying that
The second type of medical devices in China shall be examined and approved by the national (NMPA) from 25/06/2018.He advised me to keep checking on GDDA for update/approval. He asked me which product I am so keen to check. Then I answer it is the PRIZMA.
He said " oh, i know this product, so far as I know it is still being processed"
" How much longer do we need to wait?" - SILENCE
He explained to me it is NOT only Guangdong class two medical equipment, but also innovative medical. In his view, the innovative category have diff process.
i can only find one innovative product get approved in Guangdong Province in 2018 - from a separate website/articl - not too sure about this, will confirm later.
I checked some other article saying that guangdong is first few provinces to do online lodgement and can check for the status by entering the application ID.
Hope we can see the Trading Halt Announcement ASAP.