Regulatory Open Forum

Hi. 

We have been contacted by a third party in China who would like to distribute our Medical Device. They claim this can be done without approval from the Chinese FDA as they are a wellness centre. Has anyone come across this before, are there instances that allow MD's to be sold through a third-party/wellness centre or for Research purposes? I am not convinced.  

We are a SaaS product, so no physical device. 

Dear Anon

Assuming that your software falls within the definition of medical device in China, then I would disagree with the third party.

Historically there had been some uncertainty in China surrounding whether medical devices sold into wellness or beauty centers still require medical device registration. Whilst we would advise our clients that registration is required, the position is now clear that registrations are mandatory following recent regulatory guidance documents - see especially technical review guidelines issued in 2023 relating to radio frequency (RF) beauty devices (No.8-2023).

Appreciate that this guidance relates to physical devices, but such guidelines show the increasing scrutiny and enforcement risks of use of medical devices in not strictly medical settings. Even so, there will no doubt continue to be distributors and third parties who successfully exploit lack of enforcement and regulatory resources to sell via such 'gray' channels.

Read the CMDE notice here: Notice of the Center for Device Review of the State Food and Drug Administration on Issuing the Guidelines for the Registration and Review of Radio Frequency Beauty Devices (No. 8 [2023]) (cmde.org.cn)

Read a Cisema blog post with interpretation here: China radio frequency beauty devices to be regulated as Class III... (cisema.com)

Wellness center products esp. aesthetic beauty devices and cosmeceuticals are a strong trend in China. We have a number of clients in this field across medical devices (incl. SaMD), cosmetics and health foods. Happy to speak further for specific advice.  

Regards

Hamish