China MedTech Compliance: Regulatory Risks, Rewards, & Strategy with Elaine Tan

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation’s stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is that existing international certifications (like ISO and IEC) do not guarantee compliance, requiring local type testing and adherence to specific national standards.

The conversation addresses how global medical device companies can structure their strategy amid ongoing geopolitical shifts and the "China for China" policy, which favors domestic products through initiatives like the Volume-Based Procurement (VBP). Strategies such as the dual-strategy approach—localizing low-consumable manufacturing while protecting high-technology IP through joint ventures or careful CMO/CDMO selection—are explored as pragmatic ways to secure market presence and margin. Understanding the regulatory landscape, particularly the NMPA's 2021 overhaul, is crucial for success.

Finally, Elaine provides practical guidance for regulatory professionals intimidated by the market. This includes understanding the specific regulatory and clinical pathways, performing a gap analysis against Chinese standards (Product Technical Requirements or PTR), and the critical process of selecting and qualifying a local partner/agent. Elaine reveals a specific, often overlooked hurdle: the agent must possess an NMPA-approved CA (Certification Authorization) USB key to electronically submit registration files on behalf of the foreign manufacturer, a critical piece of the submission puzzle. The discussion also touches on leveraging special zones, like the Hainan Free Trade Zone, for crucial real-world data collection applicable to the Chinese population.

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Key timestamps

• [02:40] Introduction to Elaine Tan, MedTech Chopsticks, and the show’s focus on the China market.

• [05:05] High-level risks and rewards: complexity, lengthy registration, local testing requirements, and IP concerns.

• [08:08] Discussing the NMPA's 2021 regulatory overhaul and the geopolitical shift toward "China for China."

• [11:00] The Dual Strategy approach: balancing low-end localization with protecting high-tech IP.

• [14:48] Using CDMOs/CMOs for pilot projects to manage financial investment risk.

• [16:20] Leveraging the Hainan Free Trade Zone (Bo’ao region) for pre-market clinical data collection and urgent needs product access.

• [18:42] Ethological differences and their impact on clinical data justification (e.g., Pulse Oximeters).

• [20:17] NMPA predicate search: The importance of using the Chinese Classification Catalog to find registered, local predicate devices.

• [23:00] Guidance for overwhelmed regulatory professionals entering the China market: Clinical strategy and Product Technical Requirements (PTR).

• [25:52] Pitfalls in partner selection: The necessity of the NMPA-approved CA (Certification Authorization) USB key for submissions.

• [29:30] Partner qualification: Ensuring the agent can support Post-Market Surveillance (PMS) and QMS self-inspection requirements.

• [30:52] Final pitfall: International compliance (ISO/IEC) does not automatically ensure China compliance.

Top takeaways from this episode

1. Mandatory Localization is Key: Be aware that high international compliance (ISO, IEC) does not substitute for mandatory local type testing and adherence to China's specific Product Technical Requirements (PTR). Factor this into your R&D and budget early on.

2. Employ a Dual-Strategy for IP: For high-tech, innovative products, avoid placing core IP entirely within China. Consider a hybrid structure using joint ventures, strategic CMO/CDMO partnerships, or utilizing international patents to safeguard your know-how while localizing the manufacturing of less innovative consumables.

3. Leverage Special Pathways: Explore regional initiatives like the Hainan Free Trade Zone (Bo’ao region). This area allows for early, pre-market clinical collaborations to collect essential real-world data on the Chinese population, which is often required to justify clinical significance based on ethological differences (differences based on race/demographic).

4. Vet Your China Agent Rigorously: The most critical qualification for your foreign regulatory agent is not just experience, but their possession of the NMPA-issued CA (Certification Authorization) USB key. Without this physical credential, they cannot electronically submit your registration files.

5. Understand NMPA Predicate Rules: When developing your clinical strategy, the NMPA requires the selection of a predicate device that is already approved and registered in the Chinese market, regardless of whether it is domestic or foreign-made. Use the NMPA Classification Catalog to find the correct "common name" to search their database effectively.

References:

• NMPA (National Medical Products Administration): The regulatory authority in China responsible for medical device approvals and oversight.

• Product Technical Requirements (PTR): A key NMPA requirement document defining the specific performance, testing, and compliance standards for a medical device in China.

• Hainan Free Trade Zone (Bo'ao region): A special economic and medical tourism zone that permits the use of certain internationally approved, urgently needed medical devices before formal NMPA registration, allowing for local clinical data collection.

• Elaine Tan's LinkedIn
• Etienne Nichols' LinkedIn: Connect with Etienne

MedTech 101 Section

Ethological Differences: In the context of medical devices and clinical trials, "ethological differences" refers to the variations in biological, anatomical, or physiological characteristics between different human races or demographic populations. A classic example is a pulse oximeter: because the device measures oxygen saturation based on light absorption in the blood, the different skin tones across populations can affect the light's absorption rate. Therefore, data collected only on one demographic may be insufficient to prove clinical safety and efficacy in another, requiring local testing for products sensitive to these population differences.

CA (Certification Authorization) USB Key: This is a crucial physical piece of hardware, similar to a security token, issued by the NMPA to accredited foreign manufacturer agents. It functions as a unique digital signature and login credential, which must be plugged into a computer for the agent to access the NMPA's electronic platform and successfully submit all regulatory and registration documents. Its possession is non-negotiable for an agent handling foreign medical device registrations.

Memorable quotes from this episode

"The requirements that you have fulfilled in the earlier stages might not be sufficient to enter market. They need to have local testing [and] need to compliant with the local standard." – Elaine Tan

"For China, NMPA would like to actually emphasize that you need to select a predicate which has been approved in China markets already... This product has to be already registered to be valid and to be applicable to be used as a predicate device." – Elaine Tan

Feedback Call-to-Action

We want to hear from you! Your feedback is invaluable in shaping the future of the Global Medical Device Podcast. Did this discussion help clarify your strategy for the Chinese market? Do you have experience with the NMPA's CA key or the Hainan Free Trade Zone? Send your comments, feedback, or suggestions for future topics directly to podcast@greenlight.guru. We emphasize personalized responses, so reach out—we’d love to hear your insights.

Sponsors

This episode is brought to you by Greenlight Guru, the only MedTech-specific platform providing both QMS (Quality Management System) and EDC (Electronic Data Capture) solutions. Navigating the regulatory complexities of the Chinese market, including meeting the rigorous Product Technical Requirements (PTR) and managing extensive documentation, demands a specialized system. Greenlight Guru's platform is designed to streamline compliance for multiple global markets, ensuring you have a secure and compliant foundation for your device’s entire lifecycle, whether you're dealing with local type testing or post-market surveillance audits.

Transcript

Etienne Nichols: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Everyone, welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. And today we're diving into the one of the most complex and misunderstood markets in MedTech.

Or at least for me, maybe, maybe it's not for everybody, but that's China.

To help us untangle it, I'm joined by Elaine Tan, creator of MedTech Chopsticks and one of the sharpest voices translating China's regulatory language into plain English. So, we're going to talk about real risks and rewards of entering China, how to navigate the new regulatory realities and what it takes to build a strategy that actually lasts.

So, Elaine, welcome to the show. I don't know if you want to touch on some of your background or MedTech Chopsticks. I love what you're doing with that, but yeah, sure.

Elaine Tan: Thank you so much for the invitations. It's a pleasure of mine to be here.

And I first started to have this math chopstick is because I realized that lot of manufacturers, especially working in EU, many people are struggling with first of all information right back to them. There's a lot of information which are not available in the English languages.

Therefore, I feel like there is an opportunity kind of miss from many of the manufacturers here. This is how I decided to come up with the idea of MedTech Chopstick which many will be very interested about how this name came from.

So basically, we can always eat with two chopsticks. All the food is available with two chopsticks, and I wanted to try to combine MedTech and also Chopstick because it also kind of encompass my background as well.

This is how the origins of the name came from and I used to have backgrounds from biology and also for biomedical science.

And I first stumbled points about regulatory affair or also market access compliance. When I was after graduation, I had the chance to work with the pharmaceutical company as an independent consultant.

This is how I thought about oh, there was actually a field which is untapped and it's. It is very interesting.

So, I joined also as a manufacturer perspective, and I also joined further as a in a consultancy company based in Germany, but it was the hat headquarter in China.

And based on my experience now I feel like I have learned a lot from the perspective as a consultant and also as legal manufacturers itself. It makes me feel like very interesting.

And the more I read, the more I'm also kind of fascinated about how the trend have been changes.

Etienne Nichols: Yeah, yeah, that's great. And I.

I think you're right, it does feel untapped and it could be that I'm just out of the loop on the conversations that take place or the market that is the different products that are entering the China market.

But I'm curious what you think the high-level risk and rewards are. What are the attractions to bring a medical device to China? And maybe what are some of the risks of bringing a medical device to China?

Elaine Tan: Yeah, definitely.

So, when we think about China market everyone has two things pop up in mind. First is it's very complicated market because it also takes very long time to do the registrations and they have a very complexity in terms of the regulations and standards.

Many of the manufacturer might also have the things like yeah, we have already all the certifications for the IEC and also for the ISO certification model. Would that be sufficient actually to be able to be accepted by China authority in many countries EU and also US is used as a baseline for the registrations.

But nevertheless, for China this is a different story.

They need to have local testing type testing itself and then they have also need to compliant with the local standard. So, this kind of already set a different kind of better view for the manufacturers since that what things that you.

The requirements that you have fulfilled in the earlier stages might not be sufficient to enter market.

And then there was also another thing which manufacturers are very worried especially when they're dealing with the technology and also high tech know how which is the IP. This is something they usually also be also very insecure about that.

And for in terms of China why it makes it kind of like let's say an attraction but also a risk is that China is being known as like execution quickly.

And this is why many of the people including also yeah manufacturer with the innovations they are also very kind, very kind of self-aware that at any things that we have in the in the market will be very easily to be also employed in the countries as well.

So, for example I will see also from a different perspective where we always have external and internal competitions as well. What you have known and introduced in the country. It also creates another internal competition within the country.

And it helps also innovations in the kind of like high in the high level.

And of course, we also see that there is kind of a shift of the trends where currently in China the manufacturers are no longer kind of like focusing on the low-end consumable there have been some movement of the manufacturing industry to Southeast Asia as well.

So, and this is one of the reasons why that people can.

Manufacturer can feel like this is a very competitive market where we can see that also it. Can it improve how is the markets going to kind of move forward and also the cultural aspect as well.

And if we are not able to evolve as fast as the Chinese market itself, it could be existential risk in that perspective.

Etienne Nichols: Yeah.

And so, if we just take a step back and look at just the China regulatory. So, what the NMPA is a national product, National Medical Products Administration that was updated through several key regulations.

I think it was. Was it 2021 that the massive overhaul of the medical device regulations came into effect to replace the previous framework. And that to me is. It looks to me like an interesting opportunity for medical device companies.

And if nothing else because you know, high barrier to entry is high reward for those who are able to overcome that.

And I know there's a lot of geopolitical changing that's happening and different, different powers are shifting and so on.

Is China for China, is that strategy where you deliberately keep R&D and manufacturing from your global operations? Is it now something.

I guess what I'm curious is if you have a global company, how do you make sure that. That you can market in China and effectively market other places as well but particularly be effective in China.

I'm curious what your thoughts are maybe from. We can look at this from a regulatory standpoint because I know you're very excited about those things and I love seeing the passion.

Elaine Tan: Yeah, definitely geopolitical situations. It has been a lot since a couple of years and we also know that in terms of the China economy as well, it has been improved through several decades and now we have the increase in labor costs and also supply chain disruption.

And then now on top we have a trade war and also, we have tariff.

So, in that perspective, talking about China to China. So, there have been actually several, let's say initiatives have been launched by China governments, including NMPA as well. They're trying to also think about what kind of things they are trying to promote in the country in that perspective. And, and if we think about the China initiative, there's a couple of them since let's say it actually started from 2015 already and then from 2021 is also there is something about the procurements, government procurements for the imported products.

And also, by China policy we have also something I think called made in China 2025. So, there are the differences between the different initiatives that China is trying to employ.

And one of the things I think manufacturer also concerned is about the volume-based procurement as well. Because this is also mean that it's setting a different kind of stages for the legal manufacturer.

Either you are domestic manufacturer, or you are the imported product manufacturers as well. Because it was kind of set a limitation about how much you can participate and how much requirements that you will be able to meet to fulfill the local requirements as well as, as you also know that all this reform and also initiative from China they're going to favor more on the domestic product.

Etienne Nichols: And that makes sense. You know, I, I, I don't see why I come I think interesting when I think about tariffs and started learning about tariffs just as a tool to, I guess have a petri dish of your own product in your market.

I, is it South Korea?

I get these different places. I'm not as good geographically as I should be. But when they wanted a, an auto market they put a tariff up say okay, no other autos can, no automotives can come into our country because we want to build our own little, build our own empires to not right, not the right word but we want to, to have our own structure in place for automotives and, and, and so on.

And so, it makes sense that they would be a little bit preferential as far as that goes. But there are their gaps in the market and I don't know, you know, I don't expect you to know all the medical devices that are in China, but what kind of gaps would you expect and are there different pathways?

Of course, my background is with the US FDA I think of the 510(k), the De Novo, the PMA.

Are there different pathway pathways that are similar and that you can maybe break down and explain and that that would be helpful for medical device manufacturers.

Elaine Tan: So, one of the things let's say if we're really focusing on China is although we see there is a transformation about how the government is trying to shape the market itself.

Of course, all the manufacturers who is let's say having main margins for China market will be panicking because they will say okay now if we are not going to localize the product or we are not going to manufacture the product within China.

So, we're losing a big part of the margins here. Like how can we do, what can we do in order to still kind of securely have our margin in the market but in the meantime maybe trying to take a bit risk adverse approach in that sense.

There is kind of several approach here. If we also Talk about and also touch upon the point or concern, we have earlier about IP and so on is we see that many manufacturers have now trying to use these dual strategy approach.

So, this means that for the low consumable products, for example, something more,

let's say not so innovative in that perspective, they will be able to let's say localize the manufactured plant in China and then they can do the mass production. Because this is not really IP relevance as this is a know how where everyone has it.

It's just like okay, now we have to think about how competitive we want to be in the market, or do we think that this is fine, that if we don't get the tender or win the procurement with the government then we will be able to still survive in the company.

So, this is one thing and one approach, they were able to do it.

And the second part is let's say if we're talking about new generations of the product with the high technology and also maybe with some moat as well.

So, this is the cases where they are worried about okay, I'm trying to secure all my know how and also technical knowledge. And this is also applying not only for China market.

I believe all the market have the same concern and especially in the pharma markets and everyone if they have a new recipe out for the before the biosimilar, they will do the patents for pharma.

Yeah. For the formulas and of sort of design and so on. So, this is a similar cases that we can also employ because this is something internationally also we have the way to have the patents and for medical device cases I know that there is an opportunity that you can do the IP know how patents as well for the design and also maybe for the technical part as well.

But I'm not so detailed onto it. I know that there is a possibility that you can make extensions when you have the international patents also covering some specific market like China where this is something where manufacturers are very concerned about that.

What can be also done in terms of the perspective from manufacturer is that if you don't want to, let's say load all your IP or some technical or kind of like a core technology into China manufacturing plan, there's a way to have kind of let's say joint ventures and also with some partner in China where you mentioned that hey, we are able to do this and also we come into contract to discuss a very specific kind of collaborations where we will develop the product and you will do the manufacturer and then we do the partial transfer of the technology in that perspective and then in that way you're able to secure nicely also with the involve of the legal and also lawyer to make sure that this will be nicely incorporated. Also, you have a hybrid structure. So, some part is still done by the overseas headquarters and overseeing the partner collaborations in the country.

And another options, what we can also do, let's say is a bit similar to the option number two is that you're also be able to let's say contracting a CDMO or a CMO depending on what is your capability in the country of China.

Because this is a very kind of a blooming industry in China where not all the manufacturer a big company have a lot of revenue to be able to make these financial investments in China.

But you wanted to see that if this is. This is a new product that you haven't introduced in the market, you want to make sure that you are not over investing and then build a plan and then you are manufacturing the product.

But then it doesn't get the sales right. This is a important criteria that manufacturer needs to be really taken care of. And CDMO or CMO is a good choice to kind of have a pilot project on that and see how it goes because they also help you to secure the GMP where they already have the qualifications.

So, you do not need to additionally securing the GMP for your own plan.

Etienne Nichols: Yeah.

Okay, that makes sense. So, you offered a lot of different options there.

If we talk about early stage maybe product development. I know one of your newsletters when you talked about, I think it was in September, you talked about real world data and some additional ways of collecting data in the market that might not have been in just in specific locations, regions. I don't know. Can you speak to some of those different channels for bringing your product development to China so that you can understand, you know and get those clinical trials and clinical investigations done?

Elaine Tan: Yeah, the. The one of the newsletters I was trying to explaining especially kind of talking about is the is called Hainan region's Free Trade Zone or the PAO A region program.

This is how it calls and mostly for that regions. Let's say Hainan is first of all they were being established if I'm not mistaken it was like 2013.

They are the first one within the Hainan Province to be designated as a country first international medical tourism pilot Zone. And then by that I think around 2018.

And then Hainan is also being designated as the free trade port or let's say a special reform drone as well. And what usually let's say the reformations happen is that there's different things people can consider here.

But most of this initiative is to really encourage and also promote that the.

The let's say innovative product that we are, we have already let's say registrations in several market and it's claimed to be safe and this product for example is needed also highly sorted or let's say clinically urgently needed product.

This is how it calls in in. In China.

If you're able to justify that there's a possibility that you have a collaborations and connections with the local hospital or medical center within Hainan and you can do a kind of a let's say premarket clinical collaborations here so that you can collect the data where you need it, for example for the restoration. Because for some of the product, let's say like a post oximetal there is a kind of impact if you decided to test it, let's say within the different people as because oximetal is being evaluated their mechanism is based on how much the light is being absorbed in the blood.

And sometimes when you have a darker or you have a brighter skin color, it could also impact how the light is being absorbed in the skin. So, there's a possibility that you might have a clinically significant difference in terms of the result.

This is why it's very important for you to collect kind of clinical information which is applicable for China market for instance. Yeah. For this oximeter as an example.

Because the data you have maybe for the overseas if you don't incorporate multi center clinical trial this is not sufficient because there is the differences based on the different populations criteria here.

Etienne Nichols: So, is all of the data, can it be justified if we're using data from other places? If there's justification for, you know, maybe there's diversity in this study that was used in a different region or does all data need to be collected on local population populace? Does that make sense?

Elaine Tan: Yeah, it depends on what you have in terms of the let's say intended use and then whether this has an impact if that if the different populations will have let's say a different clinical result.

If it's not the cases, for example for other products, let's say if you have a suction tube or let's say you have some endoscopy products and these are for example more let's say intuitive where you can justify that the product is not being impacted based on let's say ontological differences between human populations.

So, these are something you can also use additionally like if you have multinationals, clinical trials ready or you have the possibility to say that this product is not innovative product.

So, we already have some of the, let's say comparative product or the predicate in China would have been registered. We can make a comparison.

There’re also several kinds of like different strategies. You can do it here because I think if we compare let's say between China and the U.S. you have the predicates and then in China you also have the possibility to select a predicate.

And for China, NMPA would like to actually emphasize that you need to select a predicate which has been approved in China markets already. So, it doesn't matter if it's a domestic product or if it's the imported product, but this product have to be already registered to be valid and to be applicable to be used as a predicate device.

There.

Etienne Nichols: Okay. And I like that word used. Was that ontological? The differences?

Elaine Tan: Ethological. Yeah, ethological. I think this is how what it means by when there is a difference between different races or let's say demographic populations.

Etienne Nichols: Yeah. Okay, that's. I'm gonna have to familiarize myself with that a little bit more. That's awesome. So, the, the thing you said there, I wanted to. To ask a very simple question I suppose about that the predicate.

Is there an easy way to search for predicates the way there is with I again being most familiar with FDA on my part. Is there kind of a similar database that's easily searched?

Elaine Tan: If you mean about predicate itself, there's kind of like database in NMPA where you can search let's say which product have been registered and what could be also kind of tips for all the manufacturers who are looking to China market and who is thinking about.

Okay, I need to have a clinical strategy because in China there's different pathway and they trying to, let's say trying to find a predicate is most of the medical device which is registered in China they usually follow a very common name.

First of all, I would say suggest when you have a product you will first need to look into a catalog. It's a classification or category catalog for China.

And here you will need to find which category you are and then you will find a quote. So, it's like FDA, you have a code like LMD and all this code as well.

In China you have like six-digit code or four-digit depend. You have the old code or the new versions of the code. The new version is at 6-digit in total.

Once you find the category which fit your product nicely.

And usually, they will have suggestions on what kind of name you should be using so called the common names.

And they are trying to ask or say suggested everyone to use the common name. So, if you have this common name, it's very easy for you to just use this common name and then you just put it on the NMPA approval database.

Then you will find a list of the product where you can find. They might be have the similarity with your product where you can use as predicate and usually you will find a lot of that.

That will be the main issue now because then you have to look into a detail okay in that perspective on the intended use, also on the mechanism of actions and also based on the indications are there any differences I need to compare with?

So, but this is a good start for you to first step filtering from the big list of the devices.

Etienne Nichols: Yeah.

So up until now we've sort of talked about a company deciding to move into the China market and trying to go through that IP manufacturing and what are the different things I need to consider in moving into this market and then how to get that clinical data.

When you, when we talk about the actual maybe they've made the decision and so now let's just pretend we have a regulatory person who's a little overwhelmed, little intimidated and thinking I'm going to go into this market that I know nothing about, what would you, what kind of guidance would you give that person?

Even just the databases or going here, learning this, going that what, what are your thoughts?

Elaine Tan: So, for the company, let's say they have not entered China markets, my first advice is really understanding what's the pathway where you need to take a look on. Because it's like if all the, any RA that we talk to, they first will like, okay, we will look for the classifications of the product to really identify what's the class request.

So they are, these are basic things.

And what is also interesting is really understand what kind how many efforts you should put into is to really know that, okay, do we want to make it localized or do we want it to let's say continue to be an important medical device and how innovative is the product.

This is also a consideration because if we're talking about IP and everything, so this is one part of it, but let's say the intuitive one is really figuring out what's the regulatory pathway, the clinical pathway and also with whom we want to, let's say collaborate with or to work with.

Let's say if you are a foreign manufacturer then you definitely need to think about okay, who is my partner that I really need to work with because you want a very secure partner and also who are able to support you a long way.

So, let's say from the opening of the conception of the product, if this is not the product have been produced or you wanted to really get into it to understand what is the requirements especially for the product technical requirement, it's called PTR in short form.

So, these are basically also to define what kind of standard you need in order to comply with. If you want to say your product is compliance and make sure that you are going to pass the testing in China.

Etienne Nichols: Yeah.

Elaine Tan: And this is the cases, I think. Yeah. Regulatory strategy, clinical strategy and also figure out the requirement in China. That will be the first three things I would really suggest to look into.

Once you know what's the requirement especially for standards, then you can think about, okay, if the product is already registered or also let's say IEC certified, you can do the gap analysis in that perspective to really understand whether there's a gap technical gap that you need to cover because you don't want to have that. You spend all the money, you develop the product and then at the end you also figure out oh, there is a performance gap or parameter gap that we're not going not able to fulfill.

And then you have to do the reverse engineering. Again, this is not what all the manufacturers want to hurt, especially the management level. That's going to be painful.

Etienne Nichols: Yeah.

How do you go through that site selection? You said, you know, finding a partner that really works for you, especially if there's a language barrier and so on. What's the what, what kind of strategy would you have in finding and qualifying that. That partner?

Elaine Tan: Yeah, so that's a very good question because I realized that many manufacturers or foreign manufacturers face this issue because they will say okay, is there a kind of a guidance like how can I know who am I talking to is actually qualified? And they have all the qualifications I think for China is that they do have a very robust framework and also guidance document for you to be able to really do the screening.

Because for all we all have QMS, we have this supply qualification process.

But nevertheless, these are very, let's say generic in that cases.

And then they don't really cover let's say in terms of the service provider. Of course, like for some testing lab we can actually have say okay, we will just screen if you have this ISO standard that you are certified to do this kind of certain test on the scope.

But for as let's say as an agent for many countries, I don't think there's a kind of a requirements about which kind of requirement and qualification you have beside okay, you have an experience working with it and then you also let's say have successful project in that regard.

But it breaks down to a very intuitive level. Like what exactly is being looked for China market is you need to also understand whether these agents are able to do the submissions for you is because for China it's not everyone who have the license for medical device can do so they need to also additionally apply for.

I think it's called CA certification authorization as well. It comes with a special USB and this is the USB that the agent itself who is accredited or approved by NMPA to be able to access and also do the submissions on behalf of the legal manufacturers or foreign manufacturers who are being contracted.

So, this is a very important criterion. I believe that many manufacturers might not know about this because they are not aware about how it works because in many countries it works differently.

Some of them they have some encryption, some of them, they have some kind of certification similar as well. But they do not have specific physical things where you plug into the computer and then allow you to access the platform itself as a form of login credentials.

Etienne Nichols: Yeah, that is really interesting.

Elaine Tan: This is one of the points. I think no one really talk about this. Yeah, it was being, if I'm not mistaken it was being implemented 2018 or even later. But this is something and they're trying to also make it more secure as well who are able to have this access.

Yeah, and there's only one person who can have it. Of course there's a possibility that you have. You can have arrangements between your agents to decide who will actually keep this one.

Yeah, but usually the agent is the one who really keeps securely this CA USP. Yeah. Let's say in that case and I'm sure there's.

Etienne Nichols: There's probably a database of those CAS. Would that be accurate with the USB for this?

Elaine Tan: I would say that most of the let's say credentials agents that you will find is also visible also on the certification approval database.

But in terms of the whole list who have the CA, that's a very good question. I maybe need to figure out. But I don't think like this.

Etienne Nichols: Well at first, I thought oh surely there is. And the more I think about it I'm like oh surely not because that, that, that would be kind of almost a violation of their privacy.

So.

Elaine Tan: Yeah, yeah.

Etienne Nichols: Well, I'm curious from a regulatory perspective, let's say that company's gotten to this point they know, they know about the USB, they know they need to contact partners and so on.

I'm sure there's still just a so many common pitfalls that companies overlook when they're planning their registration in China. Can you speak to any of those pitfalls that they may face?

Elaine Tan: Yeah, I think I wanted to add upon one point that we mentioned earlier about qualifications of picking the good let's say author representative.

So, this is one of the things I would also kind of emphasize it again.

So beside what I mentioned about the qualifications and knowing that they have this CA qualifications you also need to make sure that they do have the capability to support you with the post market surveillance.

So, what we also find that there are some kind of cases where the agent itself, they have the experience with it but since the regulations is being involved and there is actually more kind of cases where we need to make sure that all the PMS requirements, for example every year you need to have the risk assessments, you need to have a self-inspection of the QMS system and then you have the periodic safety reporting as well.

Those are being covered by your agents and also by you as well because they are the person who have to know and then to let the firm manufacturer know in case the firm manufacturer does not know or didn't have the capacity since they are kind of outsourcing this task.

But this responsibility is being held let's say by both parties as well. So, this is something it has to be very carefully taken care of because let's say foreign manufacturer usually will not get an audit most of the cases but the agents or the partner that you work with sometimes they get audited.

So, this could be also affected you let's say if they figure out that okay this year for this product you have been missing the information for the PMS reporting.

So, they will have let's say a non-compliance in terms of from the agent side. But then this might also extend it as well to the liability of the bigger manufacturer.

So, this is something I want to also. Yeah, focusing on as well. And another pitfall is also I think I also mentioned earlier is that first of all your ISO and IEC compliance doesn't automatically, automatically guarantee your compliance in China.

This is something I really wanted to highlight it because many of us, and I'm also one and sometimes question it as well because EU and also FDA and let's say Australia as well, their registrations are so much more recognized in many countries which can be used as a baseline of the registration.

And then you can have this, let's say accelerated pathway. And this is not the case for China. And we, we try to, let's say not making sure that we are not taking this assumption also for some difficult market like China market as well.

Etienne Nichols: Yeah, interesting. And how did the audits work in China? I know so like EMDR, you might be notified audited by a notified body. In the US you are inspected by the FDA, by a.

An investigator.

How does it work in China?

Elaine Tan: So basically, I believe I'm not really into so much into auditing but based on what I know from the QMS process is there's also similarity like how we have in the EU like the notify body. Sometimes you will have a scheduled one and then most some cases they have also an announced audit as well.

They decided to visit the factory. This is especially let's say prominent when they see that there is, let's say a surge of the adverse event for a specific product. For example.

Yeah, I think there was one cases, I believe it was one or two years ago.

There was an increase of the adverse events for a certain product.

And this is how NMP will say, okay, if we see that there's a lot of problem, we definitely need to dig it in. So, this is how they decided, okay, we will pick some of the company who is very, let's say actively in this market to really check and to verify like where is it came from and so on.

So, this is one of the reasons I also like let's say to read and go through the announcement from the Everest event as well. If I really know what is let's say upcoming audits that we will be also expecting.

Etienne Nichols: Yeah, yeah. That's interesting how that's just sort of human nature, I guess the FDA, same way you kind of see the trends they're investigating these specific verticals within MedTech. That's interesting.

Any other thoughts or things that you wanted to cover in this first episode?

Elaine Tan: I think there's one thing that I think which is also let's say interesting.

It seems everyone is talking a lot about the IP itself is that I thought about one thing for example about IPs is. Yeah. Just now I touch upon one stuff about okay, you can have an international IP and then you can extend to China.

This is one of the possibilities.

Another thing is that you can also try to let's say have this kind of like core or peripheral kind of patients where it covers the whole process of your developments of the products.

Where one thinks you have the kind of big frame of the coverage and then one, the peripheral one will be more specific on the core technology and maybe the algorithm as well.

This is one of the cases I can see that it might be also interesting and also working closely with patents law in China as well to make sure that is there any things that you can involve, let's say a lawyer within China to work within, especially when you have multi partner collaborations and also you want to have, you have a lot of technical exchange and you're afraid of, let's say if there's a risk of the technology leakage and also intellectual property, let's say infringements in that cases.

Etienne Nichols: Yeah, that makes sense.

Elaine Tan: Yeah. And one more thing I would find that probably interesting to mention is probably in one of my. Let me think about it. Yeah, there was one.

Etienne Nichols: I love what you've kind of laid out because it's, it, it's kind of the, a lot of it hearkens to the fundamental of global regulatory strategy. You need to determine you know, your risk class, your pathway, your regulatory pathway, how are you going to get clinical data and establishing ip, establishing manufacturing, who's going to be your partner, site selection, all of those different things are very important.

I think it's interesting because it's making it feel more accessible in my mind as far as, you know, it's not as out of reach or impossible to take a medical device to China.

And maybe you can correct me if I'm wrong on this, then maybe I would have otherwise thought.

I've, I've been trying to kind of watch it still from a distance just because with NPA coming out and, and so on now, it's been exciting to me and so I'm, I'm just really curious where the, you know, where MedTech will go in China and, and how, how those products will flow across into those borders.

Elaine Tan: Yeah. And maybe just one stop because we talk about this Hainan province, right? Yeah, maybe it's also interesting for many people to really understand like okay, what is the trade free zone as well, let's say for the Hainan provinces as one of the example of the free trade zone and they are definitely curious about, let's say if I do have product which have been approved in the EU and FDA and I see that there's a possibility that I have ethological differences, what can I do in order to collect those information without really carrying the whole new clinical trial in China?

And one of the things that, let's say a requirement to be, let's say accepted or to be approved to be used in the Free trade zone of Hainan provinces in Pao A provinces is that one thing is about your product is urgently needed.

It also considered as an innovative product in that sense but not yet registered there.

And so that you also need to figure out which institution within the zone needed your product as well. So, you can kind of establish collaborations.

And also, importantly what other specific medical purpose is for like what kind of treatments, what kind of diseases you're trying to treat with your devices.

And then based on this, the medical institutions or the hospital will need to say hey, we're very interested. We find there's actually a need, there's patient coming to us, so we will support you and we will actually file an application on that.

And also, interestingly also about qualification as well as not every hospital within that zones are able to apply for. There are some kind of like requirements you need to meet is that the hospital itself need to have the medical institution practice licenses and they have to be kind of categorized as a tertiary grade A level as well.

And they have the specialized departments who are able to operate your kind of products.

It's not every hospital are able to buy the product and say you just integrated for that. We have like we have location who need it, we will be able to do it.

No, you have to be a very specialized one who really knows about the technologies.

And besides that, of course if you have the import export of the product, you need to know the hospital itself also need to have the capability to store also transport the product.

And it has to be matched also with the condition you mentioned in your IFU and also for your label as well.

So, this is something also thinking about the perspective. This is not only thinking about temporarily having a product in the market, but it kind of have. You need to comply with the requirements which is set up for the actual introductions of the product with the NNPA as well.

And then for these cases because you are kind of like doing.

Collecting a clinical data sort of. You need to make sure that you the. The.

The hospital has the capability to also doing the monitoring of the events and also with all the trained people, professionals and be able to let's say support. Let's say if there something goes wrong like how we usually do also in the clinical trial as well.

So, this is one other thing as well. So, if there is some. If the let's say designated medical institutions say they're good, they have all these requirements and you are matching with the expectations.

So, you will be able to submit this kind of approval or request to the provincial health authority and then there will be some kind of a screening process.

So, they will screen based on the applicability so whether your product is innovative or clinically needed or urgently needed. And then they also screen for the user's capability or qualification of the medical institutions.

And then the last cases is once they have this screening done, they will send this feedback to Hainan NMPA and then Hainan NMPA will do the last screening in terms of the review of the overseas medical device adverse events and also what is their approval status in overseas and then this is how you will be able to get the process done.

And most of the cases this process is not. Is kind of let's say not really taking a long time but it's a very hard to really get into it so far and we.

So, one of the newsletters I wrote about is I dive into deep research about how many let's say important medical device have actually made use of this free trade zone of this program.

Etienne Nichols: Yeah.

Elaine Tan: Use it as a reference as a clinical data is in total, I think there's less than 21 products including also IBD.

But within 21 there is around 13 of them which is medical device only.

So, it's very complicated process even though you see that the requirements are pretty much pretty transparent. But the screening is very tough because to justify that your product is innovative is one thing.

And there are some also idle criteria that which are not mentioned by me as well.

It's a very hard one. Even though we have this program, it's already I think since 2019. So it's have been like five more than five years.

Yeah.

Etienne Nichols: Well, I'm excited to learn more about the market and how things are going that direction and I would love to you know to encourage those who are listening to definitely sign up for your newsletter.

How can people get a hold of you if they have more questions or if they want to know a little bit more about this?

Elaine Tan: Yeah. Available on LinkedIn and of course if you find it very intimidating to contact me straight away on my profile, feel free to sign up for my newsletter or just contact me through the MedTech Chopstick through LinkedIn as well.

In case you saw at some point me somewhere with the barcodes, feel free to scan them. They will direct you directly to the subscriber forms.

Etienne Nichols: Awesome. And we'll put a link in the show notes too to MedTech chopsticks and how to get a hold of Elaine as well. So, thank you so much. I really appreciate it.

This was a fun conversation. I feel like I learned a lot and I hope the audience learned a lot too. I can only imagine they get a lot of value out of this.

So, thank you so much for share.

Elaine Tan: Definitely. Thanks for your time.

Etienne Nichols: All right, we'll let you all get back to the rest of your day. Thanks so much for listening. We'll see you all next time.

Elaine Tan: See you all.

Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.

Email us at podcast@greenlight.guru

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About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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