Inside Brazil’s MedTech Market: What Global Companies Need to Know

Hello, Sean! Hello, Bruno. Good morning!

Hi. Hello.

What do you mean?

How are you? Awesome, awesome. I add a very brief, page about, on page 6, about the MedTech overview of classification, companies, so people can have an overview about, in terms of technical specificities, what's the distribution of the Brazil market.

Beautiful.

Amazing.

Thank you. So, when we get to page 6, we're just gonna switch to you.

Yeah.

Okay. And I added, a game on, linkedIn, which I'm gonna explain. It may be a total failure, but whatever. We're gonna try it anyhow. And… I'm gonna promote Francesco to co-host. Confirm…

I'm already co-host.

You're already co-host? Okay, so you can promote the people. Let's see… So, yeah, let's get started, well, in one minute. We have a minute, so that gives me time to… Find… How do I find the, copy invite link.

Take this… Okay. Good morning, everybody, or afternoon, depending on where you are. It is 1059, aam Eastern Time, and I… I'm very excited about today's first country webinar that we're doing, is MedTech Brazil. And our moderator today is gonna be Bruno Oliviera, and he's gonna be joined by Michelle and Martin and a number of others, and I'd like to invite everybody to turn your cameras on and participate in the call, but I would also like to, share something completely new.

I'm gonna go ahead and put it in the chat, the link to this, which is… Let me know if the… I have to put that in for everyone. share my screen. We've created a game on LinkedIn. today, which is a completely different kind of thing. I put the link in the chat. What I'd like you to do is go in and type in, instead of using the chat function, just use the function, the comment function on here. Say where you're joining the call from, And, how many of these 10 questions you think you can answer before we start? And, that's… that's the warm-up question. So, the instructions are here, warm-up questions, how to play, the scoring, and

This is gonna be an exciting social experiment where we're gonna sort of, live map the Brazilian medtech market and see how many substantive comments we can actually generate in here, about, you know, what your opinions are, and you get extra points if you use a, a link. or citation. Tag somebody who's relevant, and write a thoughtful response. So, yeah, you'll find all the questions there. Now, Bruno and I met, I think 2 years ago, if I'm… if I don't… if I'm not mistaken, when I was first launching MedTech Leading Voice, we had… we had been in contact, and then, I ran into him at RAPS, and I was super excited to see him.

And I was like, oh, we gotta do something about Brazil. And then, then this opportunity came up. So I'm so glad that he's here, and… you know, I'm gonna… I'm gonna be perfectly transparent. Yesterday morning, I knew nothing about the Brazilian medtech market, except for the helpful post that Martin does about the Invisa regulatory updates, and so I'm excited to learn from… From him and from all of you. what's going on in Brazil's… in Brazilian's med tech market? Let's… let's map it out. Let's work together on this. So, feel free to add your comments, and I am going to stop sharing that, and let…

And let Bruno take over.

Okay, okay, thank you so much, Sean. Thank you so much, you know, for everybody that is attending. It's a pleasure and an honor to be alongside you guys. I knew Martin and Sean already from LinkedIn. Now, I got to know Michelle. Hello, Michelle. And it's, you know, it's a really great moment for me to be able to present a little more about the Brazilian landscape in matters of regulatory affairs. And, you know, please, everybody, be welcome to, you know, send your comments, raise your hands, you know, share your doubts. We're here to discuss. Brazil is fascinating for a lot of reasons, and I hope to share, you know, at least most of them with you.

So I will share my screen. As I understand, I'm working as a moderator, so, you know. I will go through each of the phases and the steps that we put here. What am I sharing exactly? Am I sharing the correct screen? Okay.

If you go to share up here… Yeah. Cool.

Yeah, huh. Okay, so, let's… let's begin. A little bit about me. I'm working as Director of Business Development and Marketing in a technical and regulatory consulting company that you can see here. It's, I don't know how to… Yeah, MSC Magic? But I'm very, you know, restless, so I do a lot of stuff. I work also at AB&T, which is our national ISO in Brazil, as national chair for cardiovascular ingots and extracorporeal systems. And I also work as a Brazilian expert at ISO, international level, for standards such as 14971, the new clinical evaluation standard, 18969,

A little bit with, the 2416 and 17, standards, and also fundamental standards in implants for surgery, because most of my career was, you know, in orthopedic devices. A lot of cardiovascular also, and, you know, things that are high risk, implantable, that kind of thing. I'm also National Vice Chair for the Regulatory Affairs Professional Society in Brazil. Our LNG is growing, we have around 20 people. And, you know, it's been an amazing ride, working and also meeting Sean during the last conversions. Also a little bit about MSC Med. I think our biggest strength is that we have lots of technical people, around 30 people.

We have different groupings of services, and I'm very excited to know that we're about to open our first office out of Brazil, which will be involved in the Netherlands next year. So, what is important? What is most important, you know? about this session is that we unwrap a little about, you know, everything that Brazil means, and I'm talking about both from a business and regulatory affairs perspective. So, that is why we have some very, you know. some bright numbers here, regarding our rate of growth, the size of our market. You know, it's the biggest United in America. We are… usually the hub for companies that are going, you know, to the other big markets, like Mexico, Colombia.

Argentina. We have lots of regulatory updates that we, you know, I'll go with them in the next slides, but I just wanted to bring some of the biggest guys here. You know, we completely revamped our regulatory structure in the last years for medical devices, for IVGs, for clinical investigations. Our, we really adopted, you know. MDSAP in a very, good way. And also reliance structures and… we have, I think, a very good regulation regarding softwares and medical devices, which I understand is a topic of great interest globally, and also in Brazil. We are getting, you know, more and more clients at MSC Med that are looking at SAMD.

Our private insurance coverage is growing. This is also very important for our market. We're talking about, a little more than 200 million people. It, it kind of depends on the data that you get. It's, like, 2020 million to 2030, 2050 million, it's, you know, considering the last census. And, One-fourth of these people are using private coverage for health insurance, you know, our health structure. Something that is very important is that what you know as SUS, S-U-S, is the whole structure. So, even private coverage is inside this, this structure. It's considered part of the, unique health system in Brazil.

We also have, as the rest of the world, you know, health expenditures that are growing, and, Our, our, trade signals are, you know, improving and making our… our… market, you know, bright and brighter. And this is how I pass. This is the moment that I pass the ball to Michelle, right?

Yeah, thank you, thank you so much, Kuno.

She's bringing insights, yeah.

Thank you, thank you. I feel like, we are hosting the late night show, and showing the where do the monologue to draw all the people in, and Bruno is the guest speaker, and, like, John Baptiste just sprinkles some data magic and jazz music into it. Hello, everyone, happy Friday. And, so here, like, we pull the data from, our own module, Nyquist AI, which enables you to search all the global insights for medical device, and you can search in, local language, in this case, I believe, Portuguese or English, to pull the data. So the data is… as fresh as you can get. It's, like, literally from today.

I always like… I'm a big data nerd, and I always like to use data to tell a story. So, when we see this data, this shows, like, Brazil is definitely one of the most dynamic and complex markets from the whole Latin America. Huge market potential. As of the latest data, as of today. There are over 173,000 medical devices that are registered with MVISA, which is actually much bigger than my anticipation. And this is a powerful indicator of, you know, both the regulatory maturity and also the market opportunity. So, let's break it down by the risk categories. Like, we can see from Class 1 the low risks, which is the bandages or non-invasive

instruments. This shows that there are about 5… 55,000 products, which means that, you know, the majority, like, there are still significant amount of the market are, like, low-risk products. or, like, consumables, which is not surprising for an emerging market like Brazil. And Class 2 device, medium risk, this is where it started to get interesting, and this is the largest group among all the other categories. It has 71 thousands of devices, including diagnostic equipment and many active medical tools. Class 3 is, like, high risk, roughly around 25,000 registered devices. They are typically implantables and life support systems.

Class 4, which is very interesting compared with the U.S. or, like, EU module, where people normally have three levels of risk categories, you can see there's, for the maximum risk, close to 8,800. So, which shows, from a market perspective, if I'm, like, a sophisticated or high-tech. medical device companies, this gave me hope that, even for Brazil, there's, like, a market for most complex and high-stakes technologies. The market is there. So, as for in vitro diagnosis, especially for class Hey, I know, like, some of the audience are in IBD. There are about 575 entries, a small but overall very strategic component. So I hope those datas can tell you a very clear story. Brazil is not just importing technology anymore. Like.

China, like other countries, is a major hub for regulatory activities and product diversities, and almost, like, you know, 30,000 registered companies that are already, like, working and, you know, generating profit from the Brazil medical device market. So, I see this as a lot of opportunity, and, And I will pass on to Bruno to… now we see the market opportunity, the numbers and potential market and money that is waving to us. How do we, you know, crack the code of regulatory and other, like, things we need to learn to really see the opportunity in the Brazil market.

Bruno, back to you.

Thank you so much, Michelle. Yeah, I feel like I'm in a Saturday night show. It's a very good, very good, you know, way to say it. You know, high energy.

Oh, we have Josue here.

I know this guy. Hello, hello? Hi, Jose.

There we go. Hey, Bruno, nice to see you.

Oh, it's amazing to see you!

What a nice surprise. Another day to… yeah, another… another one of those persons, Shen, you know, the people that we talk by phone and LinkedIn, you know, and…

Hello, great to see you!

Great to see you. Great to see you, Bruno. Very excited to learn more about the Brazilian market. And this is more a question for Michelle, because we also monitor, we have this data in, in Mexico that we've built with, public available data. So what is the timeframe? You say 173,000 devices, is that, from this year? Is that from, like, a 10-year span?

Historical, historical. I can quickly look at the… Oldest, devices, let me see… I have my database pulled. I think I, it's, historical.

Okay.

Yeah.

Okay, thank you. If you can confirm that later on, so I can, compare with the Mexican market a little bit.

Yeah. Awesome.

Thank you.

Great, thank you. Great to see you, Josuel. Josuel helped me a lot in my last company. My last company, I was working as a manufacturer, helping with the Mexican market. So, yeah, and, you know, talking about IVGs, this last point that Michelle was, telling us, it's the fastest growing market, you know, among the devices in Brazil. And we are talking, both about, you know. the business side and the regulatory side. Recently, we had presentations from Visa in an international seminar hosted by our association for importers and Distributors. And, the general manager for Magical Devices, she was telling us and presenting data showing, you know.

the biggest increase among all the processes that were entering her area. So, very interesting. So… Here we have some pages where we'll be exploring, some details about the Brazilian regulatory, made, maybe. Because the regulations there are very, you know, it's like a big puzzle. There are pieces that you have to… bring together to be able to work or play, depending on how you face regulatory affairs troubles. It's important to say that our main authority is in Visa, that our main regulation for the medical devices processes, like classification, notification.

Registration labeling, is, RGC751. I'm not going to be, you know, in every slide, saying all the numbers, because it's not very easy to… you know, keep telling big numbers when you're not in your language. But, I wanted to, To express, you know, to share with you, everybody that is here, the many different aspects that we have. But it's important to tell you guys that 751 is, like, the main regulation for magical devices. that, we have, this IIN74-2020, which is so important, because it tells you the correct path to, tell them visa what are the changes that you are making to a registration.

So, even though the rules for changing are in 75 to 1, this, IN would be something like normative instruction. This normative instruction tells you what are the subjects that you need to enter the visa system to classify what you want to change, okay? We also have our GSPR, You know, it's… in fact, here it's the essential requirements for safety and performance, but it's important that everybody knows about RDC848. It includes IVDs, so, you know, it's also a top-notch, very important, you know, your life. for Brazil. And we also have the good manufacturing practices.

That appear in our regulation, you know, kind of intertwined. with MDSAP, when we're talking about those four RDCs here. You know, the main one is 6365, But we will have, some important aspects to be considered in 687, Because… It will tell you when a manufacturing unit must be certified, and when we are dealing, you know, with international situations, considering the amount of decentralization of supply chains, it can, you know, get a little tricky when you are discussing the regulatory paths in Brazil. Also, something that is important, MDSAP, when you get your, good manufacturing practices via MDSAP, it lasts for 4 years, which is very good in comparison with our standard 2 years, when it's not MDSAP certified, when the manufacturing unit is not MDSAP certified.

And here we have a whole lot of other subjects, okay? As I said, it's kind of intricate to have many pieces. But for IVGs. This RGC is the equivalent of 751, so if you want to register an IVG in Brazil, you have to go through 830, for example. When we're talking about SANDs, we have another one. It brings, you know, you have to use it together with 751, because it brings some software-specific requirements. If we go for personalized devices, and somebody may be thinking, what the heck is that? You know, in Brazil, we have this personalized word for devices that we call under three categories. We may be talking about what somebody in Europe would be referring to as a custom-made device.

And we could be talking about patient-specific devices, you know, where you have a design envelope, as the FDA says. You have a design envelope for your project, and it encompasses, you know, groups of configurations of devices, and you have adaptable devices, like, you know, small plates that you can adapt when using for, you know. Maxillofacial surgeries. Hello, Martin, do you want to add something?

Yeah, Martin, what is your experience with your IBD in, in Brazil?

Oh! I was putting an IVD in a point-of-care PCR test system into Brazil. In the middle of COVID. Oh, yeah. And you would… and you would think it goes through emergency use authorization. But there's a little catch. This device had wireless connectivity, I must have decided. So…

Your sound is a little low for me.

Is it? Right?

I don't know if it's for everybody.

Oh. Oh, I know, wait, wait, wait, wait, wait, wait. Now should be better.

Yes.

Yeah, seriously.

Exactly. So, so I… I had a task to get a point-of-care PCR test system into Brazil in the middle of COVID, And I'd already got it into quite a few countries in Africa, which is also not that easy. And in quite several other countries. But the key with this device is it had wireless connectivity. I made a slide for wireless connectivity here somewhere. And… And Visa won't accept a device, even for emergency use authorization. With wireless connectivity, unless you've had it approved by Anatel, or Antel.

Yeah, yeah, Unatel, yeah.

Anatale, yeah? So, Anatale… And then, here's the key thing, right? This is what makes Brazil special, other than the coffee. And that is… The Anatel won't accept accredited testing from other sources. So you have to go to one of their accredited labs. for your… for your EMC and immunity testing. So just beware. If you've got a device with wireless connectivity, Meaning, it has Bluetooth. or Wi-Fi in it. You're going to have to have it tested before you get it approved as a device.

And then I have an extra special piece of information.

So, in this device was a module.

For running the wireless connectivity, an off-the-shelf piece of electronics. So, in the US, the FCC wanted their sticker on the module. This module wasn't even visible to the outside of the device. So when Anvisa see this module, they also want their sticker on the module.

Mmm.

So just be aware of these tiny details.

When you're getting… trying to get approval.

In Brazil. Other than that, I would say… yes, you have lots of, lots of regulations to go through. Perhaps a very good guide from your submission side of things is that Brazil is a member of IMDRF. And you will find in the table of contents for IVDs and for medical devices. all the specialities required by Anvisa, except for wireless connectivity.

Yeah, yeah.

And the other piece is… you know, we're seeing a lot of talk about AI, And correct me if I'm wrong, Bruno, but AI in Brazil is currently managed through the normal software channel. Because they don't have a specific AI legislation at this moment in time. But they will probably come up with something, because they're… you will see, sometimes, and these are ahead of the FDA. Like, with the whole blood pressure monitoring on watches and glucose monitoring, they were… they were bringing out warnings before the FDA were.

So…

Yeah.

It's good to watch Brazil, because you can get… it's almost like an early warning system for the rest of the world.

Yeah, yeah, yeah, and it's, thank you, Martin. It's an interesting point to bring, because, Brazil is, you know, is spearheading initiatives towards harmonization and regimes. And it's also something that happens because of the size of, you know, the amount of personnel in Visa. Because, for example, the area in Visa, that would be, like… the CDRH for the US, you know? In a visa, they have 48 people. for the Brazilian CDRH, you know, it's crazy. to regulate and control, you know, for all those things. So that is why Nvisa is kind of an early adopter.

If there's something that can speed up things, you know, and make things, you know, lighter, you know, less burdensome for them, they will try to adopt as early as possible. That's a very good point.

Yes, and I also think there's a really interesting point from a commercial viewpoint. But there's what Michelle was mentioning about the demographics. They have… You have a huge population, but they're very concentrated in set centres. So… You look at this large population, large country, but actually the concentrations of the populations are in very specific areas.

Yeah, yeah. I mean, the state of Sao Paulo, for example, which is, you know, economically speaking, the main state. And we have, like, 40 million of those, you know, little less than 200 million people in the state of Sao Paulo, so yeah, it's a lot of concentration. And you know, speaking about clinical… about, clinical, yeah, we have very, you know, a lot of guidances here. three documents for clinical investigations, and also one guidance for clinical evaluations, which, as Martin's pointing, you know, is really well aligned with the IMDRF guidance on clinical evaluation. Everybody went through the situations here where somebody's asking how much will it cost to do something for a visa, so that is why I brought up the fees regulation. There you find, you know, how much it costs for each kind of submission.

It's not very, you know, easy to use, but it's there. And for clinical questions, I also brought up the compassionate use regulation, which is, you know, in many situations, the first step that you can use, you know, for the clinical side of the… as you enter the market. We also have regulations for reliance, which is, as Martin pointed, this is always going, really, you know, adopting as fast as possible, and using a lot. We have our UGI regulation. For people involved with magical equipment, we have, used and recognitioned magical devices regulation that is really important for the businesses.

Our very, you know, specific grouping rules. This is kind of a mess, I have to say. You know, it's… I know that, you know, maybe somebody from the business is hearing that, but it's kind of a mess when we compare, you know, with the structures from other countries. It can give you lots of headaches, depending on what you're trying to regulate, you know, trying to bring to the market. We have this very good word, technovigilance, that is, you know, the vigilance that is focused on our magical devices, and it's from an older era, you know, as you can see, 2009. our establishment registration regulation, also here, and two, regulations, about importation of magical devices into Brazil, especially RDC81-2008. It has, like, I don't know how many amendments, lots of amendments, but it's the

The, you know, main pathway here. So…

Bruno? .

Hello, Ross.

Yeah, I had put a question in the chat, but Sean suggested I just ask. We've seen a lot of increase in Brazilian companies coming to the U.S. just this year. I think a lot of that has to do with tariffs. In… in… on China goods, making it more expensive to buy products from China, so they're looking for other countries to buy products from that are high quality, and Brazil's a great market to buy them from. So we're seeing those Brazilian products come to the U.S, are you seeing more U.S. products going to Brazil, or is that just an anomaly due to the tariff situation in the U.S?

In our day-to-day practice, we have seen a lot of, I don't know if a lot, but more and more U.S. companies, you know, are talking to us and asking about the Brazilian market. It's getting, you know, more and more common. You're getting more clients from the US, yeah.

And how about on the clinical side? We have a lot of clients that are looking for sites to do clinical studies. And certainly, Brazil would be a good market to do that in. You have a very large population in the cities. And a high quality of medicine, so what would… What is the, sort of, the… the turnaround time in trying to get a clinical study, approved by NVISA.

I don't know if I understood completely what you meant by turnaround time.

So, when we submit an IDE submission in the U.S.

Okay.

they're supposed to give us a response in a very short amount of time, but usually there are questions, and it gets stalled, and so it can take many months to get an IDE approved, and I didn't have any experience doing a clinical study in Brazil. I was wondering what… how long it takes to submit and get approved to do a clinical study.

Okay, okay, thank you. That depends a lot on the sites that you choose, because… There's a slide about that, you know, ahead, but basically, we have the ethics committees that are present in each site. And, most of them, you know. more than 99% of them are, they have CEPs. It's like they have an internal committee that's, you know, the ethical committee, and they can evaluate your, ethical submission. In parallel with Invisa, that is very good. In our order regulation, you had to go through the attics, and then regulatory. It would take, like.

3 years. Four years, and lots, lots of time. A lot of time. And now you can submit in parallel, so you activate this ethical committee in the sites, but you have to go, you know, in each site. If you have one site among them that, has what we call, you know, we call, like, CONEP, level. You know, Connect is the name of the national structure. they can, move faster with your, regular… your actual submission, okay? So, those 3 to 4 year timelines, they reduce, like, considering that you are sending a regulatory submission in parallel. To, like, 1 to 2 years, okay? It really depends, because if you're talking about lower risk classes, you know, simpler devices.

we go more, like, to this one-year side, okay? So if it's very complex and… or high class, a high-risk class, you'll go towards the two-year, especially if you don't have at least one site in your sites, your selected sites, that have this, Connect. We call it Connect Power, you know, internally. Never know, it's, they have the… High power, you know, to, choo, true. help you to evaluate this article's submission, okay? So… Those timelines, more or less.

Okay. Thank you very much.

You're welcome, and it's great to meet you, also, here online. I'm a follower.

Thank you very much.

Okay, so, We also have, yeah, the importation rules, and here we have some registration pathways, okay? So, when we're talking about devices that are class 1 or 2, you have to do a notification. It's kind of simple. It's, you know, like a form that you, few, with the information from your technical dossier, and then for devices that are classes 3 and 4, you have to do a registration, which is sending the actual dossier to Invisa, for Invisa, to evaluate. Yeah, you have GMP certification, that is very important, so… and this expects you to, you know,

to comply with the GMP. from Brazil, for devices that are 1 and 2, but you don't have to be certified, okay? If we're talking about classes 3 and 4, you have to be certified, so you need to ask and visa to go there. Look, you know, see how did your, your, quality management system. Something that I inserted here, it's important to keep the dossier up to date for devices that are class 1 and 2. We've been seeing a lot of situations in Brazil where, a visit, you know, goes for a, GMP for your Class 3 and 4 devices, and they ask, you know, for a dossier from a Class 2 in the midst of the process, so it's good to have your dossier updated.

And it's also important to take good care of your notifications, because Nvisa, also is looking, is doing more efforts, reviewing the notifications after they are authorized. For quality audits, what we see in Brazil is that MDSAP, you know, it's growing in importance, in adoption. People are getting, you know, more and more usage to it. basically because a visa, you know, most probably, at least, you know, almost certainly won't visit you for, to do a GMP, if you have an MDSAP certification. And also, when you ask for the Good Manufacturing Practices Certification using the MDSAP certificate, times are, you know, much less. It's like…

More than 50, 60% less time for the evaluation and your certification to go, but you still have to pay 72,000 highs. to ask, okay, so the payment is not waived. You have to… So you have to pay for MDSAP, and then pay the GMP process.

So, Stephanie, you had a question regarding MDSAP, and what… That you had put in the chat. Let me see what it said. As a foreign manufacturer with MDSAP certificate and visa does not come and audit immediately if one has MDSAP certificate. Instead, they come after a few years, correct?

That's what they said at the IMDRF meeting. Hi, Bruno.

Hello?

And I was just wondering, because I… I had a customer lately, and they were asking, well, why do I need to do an MDSAP? And I said, well. the likelihood that they're coming is gonna probably be not immediate. I mean, that's what I was hearing, but I, you know, what the officials say and what's actually happening on the ground is sometimes two different things, and I just wanted to have confirmation on, you know, how they view foreign manufacturers in terms of this certificate and not having one or having one, if there's a big difference in the approach of, and Visa.

Yeah, there's a big difference. It's a big difference of approach. Because as you, pointed well, Stephanie, they won't go, you know, right away. But… and I think it's very good that we have here… I don't know if you see my arrow. Yeah, you see it. This, regulation here, 497-2021, it gives you details about the administrative processes that a visa uses for, the GMP. And it tells you exactly… no, not exactly, but it tells you this, you know, they may go in future iterations, when you ask, you know, for the renewals of the good manufacturing practices.

And this one, this is fairly new, tells a little more about how this renewal process happens. So, there's probably details, you know, there are details there that you can use to kind of predict, and they have also issued recently, I can't remember if it's an RDC or if it's a guidance document. I can, you know, talk to Sean and bring this information back. after, but they are giving more transparency about their risk management process for, you know, choosing to go to manufacture A or B. That usually happens after seats, years… Something like 60ish years, you know, after the first, certification.

I have another question just associated with this. What's the approach, or what's the difference in approach, between Brazilian manufacturers and those outside of Brazil, like, for example, European? Is there a different approach? Is there a different, time span between Between audits, I mean, how do they… do these… I guess what I'm trying to get to the heart of is Do they see foreign manufacturers as, places where they need to audit more? Is there continental differences on their approach and frequency of auditing on-site?

Okay, I… I… you know, there's… I don't think there's an official information about that. Maybe in this last document that I mentioned, there could be something, but I highly, believe that is not the case, you know, that they would put a geographical, geographical factors, you know, to make their decision about the approaches. What happens is that if you're asking for the GNP only, the Brazilian GNP only, it will last 2 years, and you'll have bigger, you know, you have a line That is big, and that, when the specialist is in a visit, they take your process. They will take more time, you know, to evaluate the documentation.

And probably to schedule the visit, the inspection. Meanwhile, if you have the empty SAP, the evaluation time is smaller, you'll have less time, and they won't, you know, at least in the first iteration, go to the place. Also, sometimes people in Europe, for example, they will feel, like the, the, the… The inspection is very hard because, for inspections that are outside of Brazil, they will only receive the federal people from Visa. Okay, a visa in Brazil is inside a bigger structure. It's the national system of vigilance, of health visionless. It's called SNVS.

And sometimes, for example, in Sao Paulo or Parana, you know, some states inside of the country, they will send only state people instead of the federal people. And usually, the federal guys, they, you know, are a little tougher, or, you know, are a little more knowledgeable about how some things, you know, work. Including, for example, scientific topics, and, you know, usually you can expect a harder inspection against from the federal level. And, you know, nobody from state level will go outside of the country to do an inspection.

Okay, great. Thank you very much for that information. That's helpful.

Great, thank you.

So we have a lot of slides left. Let's keep moving.

Yeah, sorry. I can say…

quickly that I have a client that gets inspected regularly from Anvisa. in the U.S, and if… and when they had their MDSAP, which they let lapse. They weren't getting inspected at all. They got one inspection, and then didn't see NVISA for quite a while, so it makes a night and day difference for U.S. manufacturers, at least in that sample size of one.

Hmm.

Great.

Yeah, yeah. The words I remember… the words I remember in the IMDRF, and maybe my hearing was not good, was if you didn't have the MDSAP certificate. That foreign manufacturers would be audited within the year. You know, and if you had the MDSAP certificate, it would take us several years before they come by. Maybe my hearing was wrong, but yeah. Anyways, thanks.

Yeah, yeah, I'm pretty sure that MDSAP plays a factor, you know, You know, their trust. And, I really have to find that document, you know, you sparked, you know, a big necessity. I need to find it, but then I'll come back, then I'll come back to that. It's important, as Martin was telling us about Mattel, it's important to remember that we have a metro for magical electrical equipment. And it's, like, here we have our bodies, no, like, our notified bodies, but it's just a different name, product certification bodies. They are accredited by Metro, and you have to hire one of them. to conduct, your, conformity assessment process for your medical electrical equipment. This will generate a certificate, and you use that certificate

within Visa to register your… or notif… or make your notification, okay? Some Class 2 devices. to, to, to a visa. Here we have Anatel, as Martin was pointing. The names change a little, but the idea is the same. It's just, you know, that Anatel is focused on wireless communication. And, you know, all the interference questions that relate to this wireless communication.

In general, this is the same… in general, this is the same all over the world. Right? Even then.

Oh, yeah, yeah.

And in the US, we have… in the US, you have the FCC, and in Europe, you have this, radio RED directive. But basically, as soon as you move out of those jurisdictions. I think the least… last time I looked at, it's, like, over 150 different radio telecoms organizations that you have to get approval from. for wireless communications. And some of them require you to… to submit the device, actually, to the to the equivalent of Anatel and others. Others will let you just provide a certificate from someone else and say, it's okay.

Yeah, yeah. We have this, maybe this perk in Brazilian reality, right? That it's another agency, another regulatory agency. That is doing that. For SAMGs, I put in the chat a document that I wanted to share with you guys. That relates to, a guideline for the… software notification process. It's focused on notifications because most of the situations will fall under Class 1 or 2 of the SANDs, at least in our reality. But it's important to demonstrate, you know, your validations, your, you know, cybersecurity documentation, clinical evaluation, it's…

under RGC 657, you have to show all of this, information aligned with 751 for SAMGs. Something that is very important, and that many people don't know, is that we have economic monitoring of magical devices in Brazil. So, if you are entering the market, I wrote it wrong here, but if you are entering the market with implantable defibrillators, cardiac valves, coronary stents of any kind, or pacemakers. you have to, send economic information. You have to send, technical attributes of your device, and, economic information, because Nvisa wants to reduce information asymmetries inside our, health system. You know, they are working alongside SUS, Zeus.

To, to do that. And some hot topics for our collegiate of directors, the call, you know, It's interesting, because I was checking our Arjinda Regulatoria, or regulatory agenda, for, you know, the next years. I didn't see AI there. I think maybe it will, you know, because it's not closed, it's just a contribution document. But it's… it was kind of interesting that I do not see AI there. But we have a big battle happening about reusable magical devices and reprocessing rules. Innovative magical devices, so faster tracks, you know, so we can, you know, do early feasibility studies, for example, and, you know, get more data and more devices faster to the market.

There are regulatory updates reviewed for SANDs and those personalized medical devices that I mentioned, and we need to create a true PMS regulation in Brazil, because today we only have visuals, it's, you know, super limited, and OVISA is working on, Improving this, somewhat old regulation already. Reimbursement and market, here we have to say that you can choose to go, you know, guns blazing, to KoniTech and try to bring your device into the reimbursement rules for the entire SUS system, you know? It's a big battle.

6 months. I don't think it will be 6 months, I think it will take, you know. At least one year, because you have public consultations, there is a lot of coming and going of information. you can go to ANS, which is the regulatory agency for the private insurance, the private payment sources. And there's also this very important practical angle here, because you can, of course, also study the market. For example, if you have hospitals that are very important for you. You can study the market and understand the most important, payment sources for them, and try to convince those payment sources to, bring your device, or in fact, they will bring your procedure, okay, into their tables.

And you can, you know, kind of start small, but still get, Some money from the beginning, you know, to start your, your, processes. Here I have, you know, put all the important rules. Clinical trials, we have our registry, which is R-E-B-C. And, you know, it's widely used for people to pull the information of many different health technologies, medical devices, among them. We have this structure with ethics oversight that I was mentioning to Rob a little time before. It's important to plan for, you know, multi-centric timelines, if…

if you want to conduct a successful clinical trial in Brazil, something that is very important that is happening now are those two rules. They are very new. And they are basically changing how things work in regards to ethics committees, and how your clinical trial, you know, should be done. I won't go into details because I don't have time, but it's something to be, you know, careful about. Here I think it's the part where I bring Martin. Maybe? I don't know, when I was editing the slide, I saw, you know, marching, you know, coming and going, his name, you know. I don't know if you want to comment something, because there's a lot of information here.

I saw this slide, and I thought, oh, someone's done this already, I don't have to do anything.

That was me.

I did. Okay, okay.

Yeah, yeah.

And I think the… I think the key thing between Like, if you look at the lower class of devices in the US and in Brazil, you have to give notification. And in… in the EU, the lower class of devices. You just self-declare, you don't give anybody notification. Then you wait for an unannounced audit by the authorities. It's not the notified body that will come and knock on the door. And then you'll be one of the 80% of companies that are non-compliant. So…

Yeah.

So that, for me, that's the really key difference here. I would say Brazil's… I would say it falls into this sort of international alignment. But it's closely… more closely aligned with the US than it is with the EU.

Yeah, this is a very interesting topic. We should have a meeting just to discuss that, if Brazil is aligned with, you know, one or the other, because… It's a… it's an interesting situation, you know. Our rules, our classification rules are fully aligned, aligned with Europe. But, you know, how we handle… some processes during the evaluation are more aligned with how, you know, GE works. It's… it's an interesting discussion. We have a very strong, you know, growing market for startups and innovation. I think, you know, I need to really summarize the information. go fast, but, those guys, for example, the district and ABSS are two major players in the market that are, you know, bringing a lot of new technologies that are bursting out, you know, out of the universities.

Which are, you know, we have, very strong universities here for magical technology. Some key risks to consider, if you don't have a clear path, you know, for the entities of the market to pay for your device, you know, if it's something that is not well aligned, it's important to consider reimbursement in parallel with regulatory, otherwise, you know, things You have so much time, you know, to go into the market that it won't make, you know, it won't be very good. And as Rob was, you know, telling, ETIC timelines, you know, we have to consider that, especially now, because even our authorities, they are, you know.

Sedimenting, you know. I don't… I don't know if I'm telling you the right word, but they are, you know, Mmm… Letting the new regulations sink. Into their places, and there's some uncertainty here around that. Well, opportunities for the market. We have, you know, we have to check MDSAP, as we were telling along, you know, this meeting. We have a good amount of SAND clarity, for sure, in our regulation. So, and we, as Rob was, you know, asking about the US players coming to Brazil, we are also getting more and more clients interested in SAMG, both inside and outside Brazil. our market growth, you know, is very positive for the next years, and it's important to consider reliance. If you are in the US, in Canada, in Japan, or in Australia, and your Australian

approval is not, you know, was not obtained via the European Reliance, it's important. You know, you can use the Reliance in Brazil, and it's very good, because what we are getting, you know, from our reviews, and we have lots of reviews, a lot of database. Is that a visa takes, for sure, less time and less attention when, you know, go into the tails of, you know, each part of your submission, like. Risk management, usability, MRI compatibility, biological and clinical evaluations, you know, shelf life studies, that kind of thing. When you do a reliance that is, you know, that gets through the process.

They are, you know, definitely not going into a lot of detail, as they do when a submission is not the reliance program.

Bruno, but when you're talking about Reliance, you're talking about IMDRF, or Reliance wholly, right? Or are you talking about other reliance models? Because the IMDRF has, of course, the members of Brazil, Japan.

Canada, United States, right?

Or are you talking… Yes, yes. Because there are different reliance models out there, I just wanted to have clarification. Thanks.

Yeah, it's the IMGRF, MGRF. It's the only current reliance route for magical devices in Brazil, is the IMDRF countries. So… Those other four, besides Brazil.

A lot of companies that are coming up with novel devices, and they go after the US market, they find that they're a de novo pathway? Which is a very slow and inefficient process in the U.S. Only because I know firsthand, I've done quite a few of them. And I often end up recommending to companies that you might want to try another country, and they're like, oh, should we go to Europe? I'm like, no, that's just as bad. It'll also cost more. But, Canada is a very fast route for a lot of them if they're a Class 2 device. But I'm thinking that going to Brazil might be another option to them. As well, you wouldn't have that reliance process

But, you would have a market that's in between, or very close to the size of the U.S. market. So it would be more attractive from a financial standpoint than going to Canada, which is 1 tenth the size of the U.S.

Yeah, yes, that's a very good reasoning, I think. And, you know, regarding both size of market, financial power.

Yeah, and I think the reimbursement advantages might help them as well, because with a very novel product, reimbursement.

Yeah.

a little challenging.

Yes, yes. Yeah, reimbursement is always challenging, I think. It varies a lot between the countries. At least, you know, in my regulatory life. I've seen reimbursement involved. It's another area, right? Okay, so, those things are very important here. So, always confirm risk class and root, but always confirm grouping, okay? It's very important. It will get you out of the market if you don't do a good job. dealing with the grouping rules, foreign visa. It's… Kind of messy. It's important to, you know, decide clinical evidence plans, register studies if that's the case, consider that our clinical evaluation is really close to what the IMDRF is telling us in our guidance.

If reimbursement's important, you may go through KoniTech or ANS, you know, those are two different instances. The good side of going to Kony Tech, if you think you can, if you have, you know, the budget and are organized enough, is that after 6 months that, technology is approved by ConnieTech, it must be, incorporated, by ANS. That's a very good point. Also, if eligible, you know, enroll in the SAP to, you know, avoid getting lots of visits from Visa. Oh, and that's it! A lot of information. Sorry, guys, if I, you know, I was a little overwhelming. But I try to be, you know. Thoughtful of all the aspects.

and perks of the Brazilian market. Those RDCs here are about 20-25% of all the RDCs that we have in the country, so… It's a lot of stuff. Thank you so much.

Thank you. Thanks for doing this on short notice. Thanks to Martin and Michelle for their contributions as well. Rob and Stephanie, thank you. I really enjoyed this. I learned a lot about the Brazilian market. I don't know about anybody else. I, as I said. yesterday morning, I woke up, and it was like, I don't know that much about the Brazilian market, let's go. And, you know, some, some, deep research queues later to, ChatGPT, and I was well on my way, and then, you know, Bruno, filled in the gaps, and, this is… this is awesome. Yeah, you know, I try… try the game that I put in the, in… in…

LinkedIn, and next week, let's see, next week we're gonna have, Franklin Health is gonna be a new CRO, based in the UK, is gonna be presenting on 5 biggest mistakes. I don't remember, you know, in getting your clinical trials started, something… Like that, so, yeah, come out next week, for a clinical, Outlook, and then, we have a number of other interesting ones coming up. Rob is going to be presenting on his, new lead auditor program. I don't know how many of you were on yesterday. His, he did a webinar with Jose on,

Iec 62304, and that was very helpful. We have a bunch of webinars coming up on MedTech Leading Voice. You'll find them all on MedTechLeadingvoice.com under our events. And don't forget to follow us on YouTube, subscribe, tell a friend, bring a friend, and… interact with the other… with the other, participants. I encourage you to network among yourselves, and make… make connections. That's what this group is about. And, Yeah. Well, I hope to see you next week. Comments?

Well done, Bruno. Thank you.

Thank you, Stephanie.

Fair enough.

Thank you, Rob.

I loved doing that. Let's do it again. Go on it.

We, you know…

bigger notes.

Is everyone…

Yeah.

Great weekend. Thank you. Happy Friday. Bye.