SFDA - Product Registration and Establishment Registration

[SGquality]

Dear friends,

I am aware of the US FDA regulations on Product Registration and Establishment Registration for finished device but wanted to know more about the current SFDA regulations.

We have been approached by our customer to manufacture "components" for a dry powder inhaler in one of our Chinese plants for a device that would be marketed in China.

In the situation as described above, is it required to go in for SFDA's Establishment Registration or Product registration ?

Alternatively, if we assemble and manufacture a finished device (with Pharma ingredient), who is required for product registration - would it be we or our customer ? This is because our customer is of the view that as per SFDA regulation, the "manufacturer" ie. we, are required to submit the product file to SFDA. In case of other regulators, the person holding the design is responsible for biocompatibility and clinical trials and thus its the customer who submits the documents to the regulatory body.

Pls advise and thanks for your information.

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[Marc]

Another quick "Bump". My Thanks in advance to anyone who can help with this one.

[jackfrost]

In Reply to Parent Post by SGquality

Dear friends,

I am aware of the US FDA regulations on Product Registration and Establishment Registration for finished device but wanted to know more about the current SFDA regulations. <snip>

I don't think a component manufacturer need establishment or product registration. But it depends on your customers' request. After all, a QMS is a necessity for a MD components supplier.

Contract manufacture is allowed for dry powder inhaler in China. So who is required for registration depends on your own strategy. But if your customer want to be the legal manufacturer, it should have establishment registration.

[Marc]

Thanks, Jack. I appreciate the post.

If anyone else has any comments, although this thread is a couple months old, additional responses will be appreciated.

[MIREGMGR]

I can't speak to the particular circumstances of your situation, but when the company for which I work is approached to perform as a contract manufacturer or component supplier, we satisfy ourselves that our customer will have a viable regulatory stance and that whatever regulatory stance on our part would be normal for the situation will be consistent with that expected customer approach.

Our underlying assumption would be that we will be responsible--whether we planned to be, or not...for everything we do for which our customer does not accept and properly handle responsibility.

Things normally work out fine, but if hypothetically they didn't, we would discuss the issue with the customer and, if a mutually regulatorily satisfactory plan could not be agreed on, decline the job.

I'm only familiar with the abridged English-language summary published by SFDA, not the real rules in Chinese, and experience has shown that the English-language rules are very different from what actually happens in at least some cases. However, based on those English-language rules, I hadn't been aware that SFDA utilized the concept of a "component maker", in the 21CFR 807.65(a) sense. Therefore, if the customer says that they only expect to be a distributor, then you would be the Manufacturer by default.