China SFDA Medical Device Software Requirements

[GGReg]

SFDA is insisting we must submit extensive software documentation along the lines of that described in IEC 62304 (translated as SW Description Document, Implementation of SW Life Cycle, SW Requirement Specifications, SW Test Reports, SW Risk Analysis Report).

Our relatively simple, handheld, button-operated, Class IIa diagnostic B-mode ultrasound devices contain no standalone software. Their embedded firmware is not user programmable and all of the very low ultrasound output values are preset, but SFDA is subjecting the devices to their highly demanding software requirements anyway. The software risk classification for these devices is A -- the lowest possible. Much of what they ask for is simply N/A, as I keep telling them.

We are not willing to provide proprietary information due to well-founded fears of reverse engineering risk, so we walk a fine line re: what we're willing to disclose (and they want it all). But after three back-and-forth argument sessions I am ready to acquiesce. Can anyone comment on successful strategies or direct me to sample/template/example medical device software docs that successfully met SFDA's demands?

Thank you.

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[liuyy]

see “MD SW registration requirements关于医疗器械软件注册申报基本要求的说明"
http://www.cmde.org.cn/CL0104/1882.html

[rsavoie]

Hi GCReg,
We have just been requested to provide the same information as you've stated, and are also attempting to decide how much we are comfortable with providing. I find it particularly interesting that their guidance document (linked in Chinese by liuyy, but I have a copy in English if anyone wants it) is quoting FDA statistics for software recalls in the US as justification for increased vigilance in China. They don't have any data on the safety issues or recalls associated with the leagues of Chinese-made devices domestically, and instead are focusing their concern on foreign made devices to increase overall safety? This logic is suspect to me.

Anyway, opinions aside, it seems to be a real struggle to find the balance that you're speaking of. We are also not hot to provide our IP to SFDA unless truly necessary. Also, our device has been substantially the same for the past 12 years and based on the same software platform and technology, with no known software related adverse events ever reported worldwide with a large installed base. It makes little sense for us to spend weeks putting this dossier together for them except to meet an ill-fitting set of requirements from a blanket mandate.

GC, I'm particularly curious as to your experiences in negotiating with them. Are you actually negotiating with your Chinese agent, or with SFDA directly? How low of a bar have you tried to set with your submissions, and what have they demanded in return?
Any anecdotal help is greatly appreciated, as we're about to go back to them with our own proposal soon.

[GGReg]

Ever since they forwarded me another device mfr's confidential submission docs as examples of what they're looking for, trust has been shaky. I finally crafted a one-off SW description doc and gave them our SW risk management and other supporting docs as requested, but was careful not to provide any proprietary info. It is difficult to educate each reviewer re: differences between embedded firmware vs. a programmable software interface, but I did my best. Still awaiting approval.

Good luck to others. Perhaps if we collectively push back and continue to emphasize these defining differences, we can generate awareness that 62304 is not universally applicable to every device with a UI.

[Laurewen]

rsavoie, I am interested in the English copy of the guidance document you mentioned

[spectra123]

In Reply to Parent Post by rsavoie

Hi GCReg,
We have just been requested to provide the same information as you've stated, and are also attempting to decide how much we are comfortable with providing. I find it particularly interesting that their guidance document (linked in Chinese by liuyy, but I have a copy in English if anyone wants it) is quoting FDA statistics for software recalls in the US as justification for increased vigilance in China. They don't have any data on the safety issues or recalls associated with the leagues of Chinese-made devices domestically, and instead are focusing their concern on foreign made devices to increase overall safety? This logic is suspect to me.

Anyway, opinions aside, it seems to be a real struggle to find the balance that you're speaking of. We are also not hot to provide our IP to SFDA unless truly necessary. Also, our device has been substantially the same for the past 12 years and based on the same software platform and technology, with no known software related adverse events ever reported worldwide with a large installed base. It makes little sense for us to spend weeks putting this dossier together for them except to meet an ill-fitting set of requirements from a blanket mandate.

GC, I'm particularly curious as to your experiences in negotiating with them. Are you actually negotiating with your Chinese agent, or with SFDA directly? How low of a bar have you tried to set with your submissions, and what have they demanded in return?
Any anecdotal help is greatly appreciated, as we're about to go back to them with our own proposal soon.

rsavoie, I am also interested in the English copy of the guidance document you mentioned.

Thank You
ST

[jduong]

In Reply to Parent Post by GGReg

Ever since they forwarded me another device mfr's confidential submission docs as examples of what they're looking for, trust has been shaky. I finally crafted a one-off SW description doc and gave them our SW risk management and other supporting docs as requested, but was careful not to provide any proprietary info. It is difficult to educate each reviewer re: differences between embedded firmware vs. a programmable software interface, but I did my best. Still awaiting approval.

Good luck to others. Perhaps if we collectively push back and continue to emphasize these defining differences, we can generate awareness that 62304 is not universally applicable to every device with a UI.

Rsavoie,

I am also interested in the English copy of the guidance document you'd mentioned. Thanks!