Ann: Appendix 4D & Half Yearly Report and Accounts, page-46

In japan equivalent is pmda approval.
here is a link to a vid that gives you an intro:

https://www.emergobyul.com/resources/videos-japan-device-approval

I would say fda and clinical trials will go a long way toward approval time. It has some interesting info on the site apparently Japan is the second biggest MD market so will be another coop to get in their before a viable competitor. 

fda approval was such a big step for recell and i think many will know this and have been watching and waiting. For many this co has dissapointed but in reality it was all working toward opening up the us market which we have now done, growth may be not as fast as some expect and certainly is going to cost a bit to get tyere but certainly looks like it will trend upward now, slow and steady on good news. I think they will look cheap at this price in a years time if they can steadily increase sales and get traction in new markets. Not sure we will avoid another cr as sales are goingbto have to go very well at the current rate.
But you can bet the next cr if we need one toward the end of the year or this time next year will be a lot higher than current price! And think current holders would definitely be able to participate! 

gl