Thank You RedBar and others who helped in assessing the TGA...

Thank You RedBar and others who helped in assessing the TGA timeframes. Looking good on that front for relatively quick approval once CE is in place.

Turning now to China, I and others have been referring to CFDA as the approving body. It is now the NMPA - National Medical Products Administration thst will be the body to sniff and poke at Resappdx.

The process to get approval for China and the timeframes will soon become a subject of much interest for holders. Particularly when a partner is announced. I have been casting around on the websites for a few hours this arvo , hehe well one, and chose these 2 sites as a good start in getting ones head around the issue. Happy weekend reading! Although these are good short summaries to get a quick grip easily.

https://www.emergobyul.com/resources/china-process-chart
that ones a great step by step summary.

https://www.regdesk.co/an-overview-of-medical-device-regulations-in-china/
that one is good on important issues since NMPA was established since March 2018. Helpful bit re whether the device must first be approved in the country of manufacture etc.

Anyway lots of interesting issues...we need a partner or agent in china. Would it be wise to partner with Pingan or would that maybe give them exclusivity over other big players?. Should we just use a comany like those on the above websites to do the job. Experien type people?. Will we need new clinical trials in China...My reading No. Must we have TGA first. My reading No.

So how long will it take for NMPA approval Fox?

Thats a good subject for debate. Maybe we can change our thread A New Beginning to A China Beginning? Never loosing sight of the holy grail of USA FDA approval and that massive market,The China market can be just gobsmackingly wonderful for RAP.
So how long? . go on Fox!
Nah! To hard to answer. less than a year though! In Asia , it all often Depends upon which agent/partner is involved in the interfaces with the Chinese Government Authorities. I hope RAP chooses wisely. Im definitely not alluding to corruption Its just mates influence stuff that counts.

fox