Medical Device Regulations in China Part II

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

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

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

But that’s not a must.

It’s for convenience, for necessity, butI have to say, very few foreign companies submit their own submissions and hope theycan 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 wantto discuss they’ll contact this local agent first.

But this local legal agent, in the CFDA’ssense 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 agentas legal agent as well.

However, everybody has to be aware that thelegal 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 disclosedto your distributors.

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

Therefore, from my experience I have recommendedthat a company should have legal agent for regulatory issues and sales agent to handlesales 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 whichis 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 wouldhave manufacturer’s name, address and some of the basic information about product nameand model.

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

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

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

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

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

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

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

Do not even think about having your distributoror anyone in China to label them because that’s not legal first of all, and second of allit’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 somethingnew in China, as well as in the rest of the world, but has already demonstrated the clinicalsignificance in patient treatment or recovery.

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

But there are a lot of other detailed requirementsin 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 technicaldocuments to you and you provide to CFDA, is it safe? Is CFDA not going to distribute it to anyother companies in China and have my product copied? First of all, CFDA has written in their regulationsthat 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 informationto 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 worrythat 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 wantto consider, because you are sharing a lot of technical specifications with CFDA throughthis agent or distributor.

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

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

This is also why manufacturers should seriouslyconsider whether you want to use a distributor to register a product or have the companyyou’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 productinformation will be available to a third party.

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