Medical Device Regulations in China Part I

Any medical product that’s going into the Chinese market must be registered with the Chinese Food and Drug Administration (CFDA).

But the prerequisite of getting a CFDA registration is the home country regulatory approval.

For Canadian companies it’d be Health Canada product licence.

Or if the product is exempt from the regulatory approval.

CFDA regulates products basing on product classification, class I, II, III.

Class I is the least risky and easiest control and Class III is the most risky and highest control.

Based on classification, the registration requirements are different as well.

But then, Chinese classification system is different from EU, or Health Canada, or FDAs.

We should not assume that a Class I device in Canada is automatically Class I in China.

We really need to go in and see how CFDA is looking at the product and then apply the right classification to it.

In fact, CFDA is more conservative in signing classes.

In China, there’re more product that are Class III and II than Class I.

But there are sometimes when the company has a new product they don’t find a suitable class in the existing CFDA system.

There is a process we can apply for classification through CFDA agencies, however that process takes 6 months or more, which is a big chunk of your time, so there are a lot of decisions you have to make.

Do you want to go that route to apply or do you look at what’s available and what are the pros and cons.

So there’s a lot of strategy.

From our company, I do talk with the clients extensively about their product and their application, their classification in the US and EU or Health Canada, and then we’ll see how China matches this.

Is that an exact match, or almost a match,or is that a contradiction.

And those are the issues you handle prior to submission.

But this is the only way you can go in with confidence that you do have the right classification and requirements, because there’re a lot of other issues as soon as we get into submission.

But if the classification is wrong, your submission will get kicked out of CFDA right away and you’ll start from zero again.

So you definitely don’t want to make that mistake!

Class I, as the simplest, least risky product in China, has been relaxed by CFDA, not required a lengthy registration but just documentation.

So what we do is to prepare a certain set of documents providing product information and techno documents and file it.

Typically a Class I device registration can be done within 2-3 months if there’s no other major issues with it.

Class I product filing also doesn’t require CFDA registration fee, and it doesn’t have expiration date, so there’s no renewals.

So there’s a lot of advantage in having Class I devices in your product mix.

For Class II and III products however, the registration process is a lot lengthy and costly.

Class II and III products require product testing in China.

The testing has to be done at CFDA authorised testing centres.

The purpose of the testing is to validate product safety and effectiveness as well as performance.

So the testing can be pretty length, sometimes 2-3 months, and if there’re issues during testing it can be 4-5 months.

And there are extensive discussions between the testing engineers and the manufacturers.

That’s one piece of the process before submission.

Another activity that needs to happen before submission is preparing the documents.

Typically the submission documents involve lots of documents on the technical side, product research information, technical specifications and validations, as well as clinical evidence and evaluations.

Also at the end we need to provide a lot of“promise documents” to CFDA, saying all documents are accurate.

So there’s a big binder of documents we submit to CFDA every time, and this binder once gets admitted into CFDA will get into the review process.

The review process is as well pretty lengthy.

For Class II products, CFDA’s minimum review time is 60 business days.

For Class III medical devices it’s 90 business days.

After the first period of review, CFDA will come back with certain questions, and then we’ll gather and prepare more information and material and submit back to CFDA for additional review.

So you can see the entire review time can be as long as 6 months or over a year.

We just talked about Class I device which is sort of cheap.

But for Class II and III products it’s an entirely different story.

So the testing by itself is a big investment.

Besides that, CFDA also charges registration fee for each submission.

For a Class II submission, the CFDA registration fee is roughly 35,000 USD.

For Class III device it’s about 52,000 USD.

So you can see it’s a big chunk of money that needs to be allocated to the China project.

This is also why I talked about that the pre-registration planning is so vital because any miss-steps in the process that you got to re-do, there’s additional time and money.

Since the release of the new regulation in 2014, clinical trial has become a very hot topic in the regulatory world.

Many companies are very aware and concerned with this requirement.

From CFDA’s perspective their objective is to make sure the products are safe and effective.

Unfortunately in the past there have been a lot of issues with products in the market, so understandably the CFDA is quite conservative and wants to plug that hole.

But at the same time, they are also putting in some stringent requirements which may be a bit over reach comparing with the rest of the world in clinical evaluation.

For Class II and III products, if the device doesn’t have a predicate device, meaning a similar product which is already approved in the market, the company may have to consider a clinical trial in China.

But this is not for every product.

CFDA does have a clinical exemption list.

In September this year (2016), CFDA just released the 2nd batch of Class II and III product exemption list.

So everybody who’s going into the registration process, this is another due diligence we have to do to see if the product falls into that list or not, and if not, how you remedy that gap.

The exemption list at the same time is also being revamped.

I know that companies are very concerned about this, saying, if we have to go into China with a product which was already approved,are there any other alternatives? There are.

I wouldn’t say the CFDA regulation is set in stone.

Regulation in China is like the rest of the world.

It keeps on evolving.

Even though CFDA might be a little bit behind,but they are really in the same direction.

So we just have to hope that things will get a little easier.

However, if you are required to do clinical trial, you really need to get familiar with the CFDA regulations on clinical trial.

One should not just contact a hospital and say I can start a trial because I have a protocol, because CFDA has strict regulation on clinical trial.

In recent months, the clinical trial is the top surveillance target for CFDA.

Also based on product risk category, there are requirements for protocols to be approved by CFDA.

If your protocol doesn’t need to be pre-approved by CFDA, at least your protocol needs to be filed with a local provincial FDA office.

For example, if you’re doing a trial with a hospital in Beijing and in Shanghai, your trial protocol needs to be filed with both Beijing and Shanghai Food and Drug Administration.

You can’t just go in and get started.

And of course for every hospital that’s experienced with clinical trials they also have IRB that you need to get ethical committee’s approval and all the other requirements.

These requirements will have to be complied,otherwise the trial report is not going to be admissible to CFDA at registration.

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