Medical Device Regulations in China Part II

Technically, anybody who wants to register a product with CFDA can apply, however because of the language issues, the distance, and the knowledge about the regulations, a lot of companies that don’t have a China regulatory team or they’re new to the Chinese market may want to use regulatory consultants.

Additional reason for having a local agent is that every document needs to be prepared in Chinese or at least translated into Chinese when we submit them.

During the review process there’s a lot of communication with the reviewers that has to be done in Chinese, so there’s more reasons than one to have a local consultant to work with you.

But that’s not a must.

It’s for convenience, for necessity, but I have to say, very few foreign companies submit their own submissions and hope they can get through, which typically doesn’t happen.

A lot of people are confused between a sales agent and a legal agent.

A legal agent, from CFDA’s perspective,is a legal representative of the foreign manufacturer in China.

In case that CFDA has any issues they want to discuss they’ll contact this local agent first.

But this local legal agent, in the CFDA’s sense is not necessarily a sales agent.

These two are not related.

A sales agent is for sales purposes only.

Some companies like to have their sales agent as legal agent as well.

However, everybody has to be aware that the legal agent also handles adverse event or any other negative news from the local authorities, which is a concern for international companies—do you want to have that information disclosed to your distributors.

Also during the registration there’s a lot of sensitive technical information get presented to CFDA, so the exposure of a foreign company in front of a local distributor is a concern of intellectual property issue.

Therefore, from my experience I have recommended that a company should have legal agent for regulatory issues and sales agent to handle sales due to the big difference in their responsibilities and exposure and IP issues, etc.

Every product going into China needs to have a Chinese label and Chinese user manual which is called “IFUs”, and this is a hard requirement from CFDA from many years ago.

In 2014 when the new regulations were released,this labelling regulation got revisited and new requirements were added.

In the past, the Chinese product label would have manufacturer’s name, address and some of the basic information about product name and model.

Nowadays the CFDA requires the product to have either the manufacturing date or the expiration date because of the new requirements in registration when we need to tell CFDA how long this product is good for, so they want the label to reflect that information.

The other necessary information CFDA would require would be some technical information such as power input rating and if the product is disposable or reusable.

Through my experience a lot of international companies are not paying enough attention to the label and Chinese IFUs.

I have dealt myself personally that companies got fined because they don’t have Chinese labels.

Therefore, I really want to use this opportunity to tell everybody that getting a product registration is just the beginning.

You have to make the second step which is to get all documentation in line.

Make sure the IFUs are correct and wording is correct, and make sure the label is on the product before you ship.

Do not even think about having your distributor or anyone in China to label them because that’s not legal first of all, and second of all it’ll slow your importation and your delivery to your customer.

CFDA in 2015 released a new regulation which gave a special treatment to innovative products.

Being innovative in CFDA’s sense is something new in China, as well as in the rest of the world, but has already demonstrated the clinical significance in patient treatment or recovery.

So CFDA will give this kind of products a special consideration and allow you to have a fast track into the CFDA system, so that the products can go into the market much faster.

But there are a lot of other detailed requirements in this that companies need to fulfill before going into this process.

I have a lot of questions coming from different companies asking: “If I provide these technical documents to you and you provide to CFDA, is it safe? Is CFDA not going to distribute it to any other companies in China and have my product copied? First of all, CFDA has written in their regulations that all documents submitted to CFDA are strictly confidential.

Secondly, as a principle of approving products,CFDA’s objectives are always looking at product safety and effectiveness.

So it’s our job to provide sufficient information to reach that purpose.

As far as IP issues and technical know-hows,we need to be mindful of what we’re submitting, but at the same time, we need not to worry that much as far as documents are being leaked out through CFDA.

However, if anyone works with distributors,or if the distributor is also a manufacturer, then there’re IP issues you probably want to consider, because you are sharing a lot of technical specifications with CFDA through this agent or distributor.

How they’re going to use this information will be up to interpretation.

This is also why the regulatory field has geared into a normal market like the rest of the world—Regulatory consultants are regulatory consultants, and we do not have any other commercial or manufacturing responsibilities.

This is also why manufacturers should seriously consider whether you want to use a distributor to register a product or have the company you’re partnering with to carry your product through their product line to register a product,because you’re opening up your book, even if not to the core, but majority of the product information will be available to a third party.

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