EPISODE 28: JOSUÉ GARZA, DIRECTOR OF BUSINESS DEVELOPMENT & OPERATIONS AT INSUMOS PARA LA SALUD (IPS)

Episode’s transcript

Julio Martinez: 0:04

Welcome to the LA MedTech Leaders Podcast. This is a conversation with MedTech leaders who have succeeded in Latin America

Julio Martinez: 0:14

Today our guest is Josué Garza . Hey, ue , it is great to have you here today. Welcome to the show,

Josué Garza: 0:22

Julio. Thanks for having me in the podcast. I'm really excited about this conversation with you. I pretty much listened to most of your episodes and I congratulate you because this is exactly what the Latin America region needs in order to get more exposure. The region, if understood well, and if you partnered well, can provide many opportunities in the long run.

Julio Martinez: 0:50

Excellent. Jose, thank you for being in the show. Thank you for accepting my invitation and I look forward to our conversation today. So listeners , Jose Za is the Director of Business Development and Operations at In Sumos Para IPSA regulatory affairs consulting firm, helping medical device manufacturers and distributors obtain market access in Mexico. Josue has over 10 years of experience working with the private sector, government and nonprofit organizations. And before joining IPS, he took leadership positions in the International Republican Institute, consulate General of Mexico in Orlando , Georgia, premier Destination Services and the Institutional Revolutionary Party in Mexico. Oue has expertise in managing projects at the municipal, state, and national levels, participating in public policy initiatives and developing strategies through team center processes. Today he continues to influence the growth of IPS by helping businesses from around the world thrive in Mexico and improve access to the best health products for Mexicans. UE holds a BA in international relations from Universidad IBE on Medica in Mexico, and he spends months of his time in Chicago and Mexico City , Mexico . So, ue , let's get started here by asking you about your journey to your current role. How do you get started helping companies succeed in Mexico?

Josué Garza: 2:22

Well, Julio, my , my experience, it started in the nonprofit sector. Then I transitioned , uh, well in the nonprofit sector. It was very much focused , uh, working with municipal governments, state governments, federal government. Then I transitioned to working for the Consulate General of Mexico in Atlanta. And then I worked in the political party, one of the mo biggest political parties in Mexico. And after that experience, I was like, I need to get to the private sector. I need a change. I need something that is more upbeat, faster, less rigid, with less regulation. So I got the opportunity to join IPS in Sumos and it's been , um, magnificent experience. And mainly it's been magnificent because the industry itself provides a lot of opportunities in Mexico and worldwide. So my experience in Latin America is particularly focused in Mexico medical device market and with a lot of experience with , uh, COVID priest , which is the sanitary authority in Mexico. And even though my focus is Mexico, it's important for me to know what's happening in other countries because that way we can know what our clients, which are global clients are going through and how they're being regulated in other countries. And it's important for me and for our team to be aware of what's happening in Latin America and not in in another regions. So we can know, for example, in Europe, the big topic now is M-D-R-I-V-D-R. So we can expect our clients to be stressed, to be less available , um, when we request documents to prepare their submissions. Or these clients can also see Mexico as an opportunity for their products as , uh, they consider Mexico now to be a little bit less regulated than Europe. So my journey in Latin America starts in Mexico, and it is completely focused in Mexico.

Julio Martinez: 4:48

Okay, very good. So ue , I'm gonna lump together the next two questions. The first question is, what major trends do you see in Mexico that are relevant to our discussion and why do you think Mexico is a great place for foreign companies to commercialize their medical technologies?

Josué Garza: 5:11

Well, I think that medical device manufacturers and foreign distributors should look into Mexico as a big opportunity for investment. Where do I get these ideas? Basically , uh, from , uh, from Mexico, which is now non-existent, it was brought down by this new government administration by , uh, Lopez Obrador . But before that, pro Mexico was part of the Ministry of Economy and uh , I always saw Pro Mexico as being the biggest cheerleader of the medical device and pharmaceutical , uh, industry in Mexico. And the reasons here why invest in Mexico were given to me by Pro Mexico . The data, all of the information that they were providing is basically the population is getting older. In Mexico, the population is living longer. Age is 77 years old. You know , so many industries now are focused on millennials, but that shouldn't be the case for the medical device industry. In particular, in Mexico, the medical device industry should be focusing on the aging population. The populations living longer and requiring more medical supplies, medical equipment. They, they require these products to live longer and to be able to live comfortably. There's also a big increase in chronic diseases. Unfortunately, this isn't good for the population, for the people and for the country. For the country and for the Mexican public health system. It provides a lot of stress , uh, with economic resources having to go fund these chronic diseases and to provide the healthcare for the Mexican population. But for um, healthcare industry companies, it provides a great opportunity. Approximately 50% of the deaths in Mexico are caused by these chronic diseases, which is very unfortunate. The chronic diseases that are most important in this are obesity, diabetes, cardiovascular diseases, cancer, and uh , renal insufficiency. And lastly, Mexico is also attractive because it has a consolidated purchase system for the public sector. So this consolidated purchase system is being tested right now with the current government because , um, this current government is trying to get rid of corruption, right? So he is trying to look into the procedures that are in place or that were in place and , um, he's trying to get rid of privileges or get rid of these companies that have won many tenders that they might not otherwise would've won. So in this case, Mexico with this consolidated purchase system in the public sector is spending money in healthcare. And it has the ims , which is the health services provider for the private sector workers. And in this also public sector system, you can include East Day , which is the agency that provides healthcare services for government workers. And as well in this consolidated purchase system, you can include the defense department, which provides healthcare system to army forces. And lastly, you can include Pemex , which is the state's oil company. No , and it provides healthcare to pemex workers, which they have a big workforce. Lastly, with this new administration in Sabi , which is , uh, a new institution that was created that took over ula , it's playing a larger role in healthcare and with making purchases in the public health system. In Sabi is the institute that provides healthcare to those Mexicans without access to any healthcare system . So they're not hired by any company . So they don't belong to the private sector, they're not working in the government, they're not working for Pemex , they're not working in the military. So in Saudi is for all of these other Mexicans that require healthcare services, but they don't fall under the other institutions where they can obtain these healthcare services. And interestingly enough, now under these new circumstances with the pandemic in Sabi is taking an important role in making all of the purchases that , um, are required to fight this pandemic in Mexico. So before that, each institution was in charge of doing their own purchases or asking for their own purchases, or the purchases came from a couple of tenders that were published in the Cuadro vaco or in the , um, medical supplies list that were posted annually. But now in this pandemic, in this new situation, inab is playing a big role. They're purchasing over 24 million medical supplies to contain this pandemic. And they have allocated a lot of resources. So it's definitely a big test for in abi , which is received a lot of criticism by former ministries of , uh, health. And , um, it's a very big test for , uh, insa in the purchasing of medical equipment, medical supplies . And we might see different approach in how medical supplies are being purchased after this whole pandemic scenario is, well, you know, this whole pandemic scenario is , uh, it's resolved . Yeah. And Mexico, it's also an interesting country. And I think that a lot of , uh, manufacturers in say United States, maybe not United States 'cause we're very close , uh, we're neighbors, so, but maybe in Europe and Asia, they don't know about Mexico. So Mexico is the largest producer in Latin America of medical devices. It is within the top 20 of exporting countries of medical devices in the world. It is number eight in that, and it's the number one supplier to the US of medical devices. Over 90% of the exports from Mexico go into the us and more or less, 65% of imports from the US are coming to Mexico. So Mexico and the US are together in this <laugh> . And uh , they depend on each other a lot. And it's obvious because we share a border, right? We're neighbors and uh, most of these products , uh, which are exported are medical, surgical or dental instruments and devices , respiratory therapy devices, orthopedic devices, and respiratory therapy devices are very important nowadays. You know , in today's world, Mexico is also within the top 20 countries for importing. So , uh, medical devices, it's number 14 in the world. The medical device sector, this is very important, was announced to be a strategic sector in the past administration. So this was pushed forward by Pro Mexico , which I've said that is no longer with us. All of the Pro Mexico representation representations all over the world have closed, their central office has closed. And Pro Mexico's job is now taken over by the Ministry of Foreign Affairs, not even by the Ministry of Economy, right? So luckily Pro Mexico was able to look into the medical device, into the pharmaceutical sector and really push forward into saying like, Hey, like this sector is very important to us. It provides a good percentage of our GDPA significant percentage of our GDP . Let's look at it. Let's consider it to be strategic. Because from what we're seeing from years back and looking into the future, it's gonna grow and it will continue to grow. And well , the market value of medical devices as well is almost , uh, 5,000 million dollars. So it's a very attractive , uh, country to invest in. And you were saying about trends, well , I don't have a crystal ball, but from all of these , uh, data and information, Mexico, I think in the future will not only be a top exporter of medical devices, it would also , uh, be a creator of medical devices, a creator of technology. Most of the medical devices that are manufactured in Mexico are because of the maquilas . And that's why you have in the northern part of Mexico clusters that are very important. And multinational companies settle there to open their manufacturing plants because they know they have a good quality labor, that it's affordable close to the us , right? But I think in the future, Mexico is going to become a key player in developing technology and not only assembling medical devices, right? And I think that's a major trend to look forward to. And as well, I think that the medical device industry, the foreign manufacturers, multinational companies that are based in Mexico are trying to push forward a consumption of medical devices. The idea that the industry has some major role to play, that the industry provides a lot of good opportunities in Mexico. And not only for safe and good quality medical device product, but also for providing job opportunities for providing also , um, development of these products. So I think that the landscape is very, very promising. I think , um, that it's important to see Mexico as a market that can present many opportunities, but at the same time, it presents a lot of challenges. You need to do a good research before coming into Mexico and not only rely solely on what your distributors tell you or what other companies tell you based on their experience, because their approach may be different to yours. However, having these different perspectives and points of view will definitely enrich your go-to market strategy. I think that a first good step, whether you've done business in Mexico before maybe 10,000 times, or it's your first time going into Mexico or to any new market in Latin America, a good first step is to contact your country's diplomatic representation. They will be often able to provide the current landscape of what's happening. They live it every day . And often , uh, these diplomatic representation will have economic or trade departments in their embassies or consulates that will have a key of list , uh, list of key industry players of trade shows of associations that are playing a major role in the country. And to talk a little bit about these associations in Mexico, I'd like to point out that there are relevant associations that I think foreign companies should look into before coming into Mexico, or if you are already in Mexico, continue looking into them because they provide valuable resources. The Mexican Association of Medical Device, innovative Industries, also known as Amit houses, a lot of these foreign manufacturers of medical devices. It is to my point, the best association of companies in Mexico that looks into medical devices. They recently published report, which is available on their website, and which I think it was created with a big consulting company, I think it was , uh, KP MG. So they look into the industry very well and they look into new trends, they look into what the industry needs to get done in Mexico in order to succeed and what their strategic plan is. You know, so if you're a medical device company looking into Mexico, or if you're already in Mexico, you should definitely take a look into this association. The other association, which is more active in the pharmaceutical industry, but still has medical device , uh, section is the national chamber of the pharmaceutical industry, also known as Scan Pharma . So those would be the two associations that I would advise companies to look into before , um, doing business in Mexico or while you're doing business here. You know, and if you looking into establishing long-term operations in the country, I would recommend to join them , uh, because they would be able to provide good resources for you. If you are a company that is looking to invest into Mexico and doing more of a major investment, and I'm talking more like manufacturing facilities, you know, and long-term business in Mexico, I would look into the clusters of , uh, the Californias, which are in Bafa , California. This cluster is very active and it also holds a lot of international companies and the biomed cluster in Juarez. So these two clusters highly recommend if you look into shifting a little bit of your strategy, doing major investments in Mexico, talking about having ground operations and manufacturing facilities. Pro Mexico unfortunately isn't with us anymore, but that was a very big and important source of information with data, with industry insights. As I said before, pro Mexico was a big cheerleader , uh, for both the pharmaceutical and medical device industry that unfortunately we don't have anymore . But for example, with potential clients that , uh, we interact with or the existing clients that we have, we share with them information that was given by Pro Mexico , which is very valuable. So that helps them a lot in getting to know the country, getting to know the industry in Mexico. It's a good , uh, first step into say an introduction of doing business in Mexico. And if you're a different type of investor in the medical device industry and you wanna take a look at what would be the Silicon Valley of Mexico, you should definitely look into Guadalajara . Guadalajara has a lot of talent in developing the technology and developing medical devices, and there are a lot of young people who are devoted, who have been coached on intellectual property, who have been coached on how to prepare your medical device. And some of them are looking for investments, you know, to grow their product or to serve as a coach, you know , uh, for their business strategy. So I think those are , um, the ways that foreign companies should definitely explore Mexico, know that Mexico is a very good country for medical devices, know where it's at in comparison with other countries, both in exports, in imports, the size of the market, and who are the associations that are reputable. And that would provide you with the resources that would help you be more at ease in investing in Mexico. But definitely, as I said in the beginning, you should always part from contacting your country's diplomatic representation because they often provide you with the current landscape, which is evolving dramatically. We have a changing government and things have changed a lot and they continue to evolve. And now with the pandemic, I'm sure things are going to shift. So that would be a good way to start.

Julio Martinez: 24:51

Great ue , thank you so much for that comprehensive introduction of the medical device sector in, in Mexico and the healthcare system. I'm sure listeners , uh, can find a lot of value on that. So let's dive into your practical experience , uh, finding distributors or reassuring products at the Mexican regulatory agency, covered priests , et cetera . Uh, I'd like to get your thoughts and recommended best practices on , for example, distributors . Let's talk about that first. How would you say a company should start finding distributors in Mexico?

Josué Garza: 25:26

Well, I think that , uh, finding a reputable in high quality distributor in Mexico is not an easy task. You have to know that from the start. There is lack of data, there's lack of information. There's not a centralized source of information regarding distributors. So, as I said in , uh, previous question, getting in touch with your diplomatic representation would be a good idea. 'cause they would often have a list of distributors that have come in touch with that diplomatic representation. And unfortunately, and I think this is not a case in Mexico only, or in Latin America , uh, we've heard from clients that they've experienced negative results , experiences with distributors worldwide. So you definitely have to do your due diligence into finding, partnering with a distributor. My perspective and company's perspective is if you want to enter the market, if you're new to this, you should go through a authorized representative, a registration holder company where you can have your registration in a safe place where often these authorized representatives and registration holders do not have any interest in commercializing your products. They don't look into that. They look into having supporting you in guaranteeing you that you'll have success in the registration process, in getting the right results before the sanitary authority. But that would be also a very good step. My recommendation is don't rely on a distributor to distribute your product and to hold your registration. Because we've heard numerous experiences about manufacturers that are held now, the registrations are held by distributors and they cannot get out of it. You know , they have to put a lot of resources in order to get out of it. And we've also heard experiences of distributors that they don't answer the phone, they disappear completely. They have in the line public tenders that they have to participate or they've won contracts with the government and they suddenly disappear. So my first advice is, if you're gonna do business in Mexico, do it through a registration holder or authorized representative that does not look or does not benefit from commercialization. That's number one. And on the other hand, there are a lot of good distributors out there in Mexico and all over the world, but you have to do your due diligence. You have to make sure that your distributor, it might sound dumb, but that you're not dealing with a distributor that has an at gmail or at Hotmail or an at Outlook email account that tells you that the distributor is not very formal. You know, that for us tells us, ah , I mean, if they don't have even a website, if there's no way for me to know or to find them in the internet, and I'm all the way over in China, how am I gonna trust someone, some other company to hold my products and to distributor and to distribute them into a market that I don't know, you know? So for us, our approach is something basic like that. Make sure that your distributor, you can have their contact information, make sure that you get references from them . You know, make sure to ask, ask, ask, ask. And I think that also you have to, there are some companies that often do business in Mexico and they don't even come to Mexico. They rely only in their distributors. So you definitely have to pay a visit to Mexico and before starting business operations, before signing a contract, making sure that even have they reported taxes, you know, are they up to date with their taxes reporting? Are they , uh, a company that we can find anywhere? Is their operating license up to date before Covid ? Please ? Do they have a post-market surveillance unit? You know, they're gonna be responsible with your registration holder authorized representative for your products in the country. So do they have the right procedures? Are they following up with the standards, with the health regulations? Do they have a warehouse? Where is the warehouse located? Does the warehouse comply with covid pre standards? There are many aspects here that foreign manufacturer has to look into before signing a deal with a distributor in , in Sumos para . We have been analyzing this, I would say , um, challenge for some years now. And our goal is to provide foreign manufacturers with a scorecard in which we are currently mapping out distributors all over Mexico. Because as I said before, there is no database, there is no information. It's very hard unless, I mean, the most common place to get in touch with our distributor are in trade shows. Uh , that's usually the point of reference in how you start forming a relationship. But our job is for our clients to have a good and reputable distributor, and that means helping them, helping our clients with their due diligence. That doesn't mean that manufacturers don't have to do their part, you know, but we can at least prescreen them with all that we know that they need to comply with before covid threes . And with all of our experience seeing distributors come and go, manufacturers telling us, you know what? We need to modify my registration again because this distributor wasn't executing well enough, or this distributor, I haven't been able to contact him in a while, or this distributor didn't reach its sales goal goals. So our approach to this is, if our clients have good distributors and we can rely on good distributors, everybody is going to do well with all of this . 'cause there is so much that goes on before commercializing your product. And that's often something that other registration, other consulting companies don't look at. You know, when a manufacturer comes to us, they're already ready to sell. Uh , probably the Latin America sales representative or the general manager for Latin America or the in-country representation of that , uh, company in Mexico has a timeline, and they have deliverables and they have to execute them. And behind them, they have their marketing and sales team from their headquarters looking to obtain results and looking finally for their return of investment. So in Sumos can of course help them and get market approval, but if the distributor doesn't deliver, or if the distributor turns out to be bad, then everything else, all of these years of developing, of putting resources, both economic and, and human resources into this whole project crumbles, or you have to pivot from there. But pivoting in this industry means a lot of months and often years. So our goal is to protect these , uh, foreign clients into working with reputable and well-known distributors that have provided to be delivering good results. You know , uh, so we're designing this , uh, scorecard to be able to provide to our clients that has a lot a list , uh, an ambitious list of <laugh> of items that they need to, that we need to cross out in order to grade them . And it will be up to the distributor whether or not they're gonna provide that information, you know? But if they provide, if they're transparent and if they're really looking into selling someone else's product and are committed, then they will provide the information. We don't see any setbacks within that. But if a distributor starts , um, not providing basic information that w would be , uh, something that they would probably need to provide when they sit in the table with , uh, the manufacturer, then, I mean, we can at least save them that trip and just cross 'em off the list. Also, the distributors need a , a health responsible license, you know, and, and , uh, and they need to be registered before covid freeze . And sometimes these distributors in Mexico, they have the capability and the scope in paper that they can distribute all types of products in all categories. Medical equipment, diagnostic agents, supplies for dental use, hygiene products, surgical materials. But in practice, they only focus in one product or they are only good in distributing one product. So we have to do that work for our clients in order to get them the most accurate information. So out of the list of distributors that we're creating in Mexico, we're also gonna segment it within the categories and , and within the expertise of each distributor, because you cannot say that it's very rare to find a distributor that has a, the capability to distribute all types of products within all the six categories that are regulated in Mexico. It's very rare for that. So our job is also to get , um, them to narrow that search and to really have the most accurate information so we can provide the foreign manufacturers and foreign distributors, new clients coming into Mexico with the information that they need to start talking with the distributors. You know, so these are like, Hey , a heads up , these are the things that you should look into. These are the things that you should ask the distributor. And so later on they would be no surprises. Well, we cannot guarantee that, but we can minimize the risk, you know? And as I said before, if in Sumos does its job by registering products and having a fast and effective regulatory process and the distributor doesn't, then I mean at the end, the foreign manufacturer or foreign distributor might look elsewhere and might not consider Mexico an attractive market based on that particular experience. So that's what we're trying to, Mexico is an important market. Latin America is an important market, but I think that oftentimes projects get canceled or interest in markets or shifts because they don't have the right partners, you know, and that's critical. Often , uh, the clients that we have are also involved in Brazil, and we often get compared with Brazil, and they expect for Mexico and Brazil to provide the same results. But I think that you have to take a look into this in a case to case basis, into a case to case event, but also be prepared and definitely do your due diligence.

Julio Martinez: 39:48

Fantastic. ue . So we are close to the end of the show ue , but I'd like to get your thoughts on Karis . Uh, could you please give us an overview of the regulatory approval process in Mexico?

Josué Garza: 40:02

Yes, of course, Julio. So Karis is the decentralized entity of the Ministry of Health with , uh, technical, administrative and operational autonomy. So Covid priest regulates many industries that represent almost 10% of the Mexican GDP. And as Covid priest has said in many of their presentations both in Mexico and international, it regulates 44 cents of every peso spent by households in Mexico through food and beverages, healthcare, and personal care products. So , uh, covid please , does not only look into the medical device industry, it also looks into many other industries such as cosmetics, food, beverage, plant, nutrients, pesticides , uh, labor, safety, and health. So covid pre has a lot of responsibility and it has a lot of work to put it in , in minor terms. COVID three also regulates the business process. So it regulates marketing, it regulates imports, it regulates exports, it regulates advertising, it regulates production distribution. So if you want to commercialize your medical device in Mexico, you have to get to know RIS or work with someone that knows how RIS works. Mexico has a robust regulation overall. So in a bird's eye view and in general terms, most of our regulation comes from the foundations and principles from the Global Harmonization task force , the GHTF , now known as the IMDR, the International Medical Device Regulators Forum. So that's , uh, kind of like the foundation and the principles for how medical devices are regulated. And from there you have the General Health Act, you have the <inaudible> , which is the health supplies bylaws, the Mexico pharmac , the <inaudible> , and the official norms, for example , uh, good manufacturing practices, labeling and post-market surveillance. So this is in a nutshell the how medical devices are regulated in Mexico and to kind of take you and your audience in a chronological path. And this is also relevant on how to obtain market approval. Uh, in 2010, covid , please signed equivalency agreements with the US and Canada. So these equivalent agreements , uh, helps to register products that are already approved from , uh, the FDA in Health Canada. In 2011, they authorized the third party reviewers, which are to date , uh, nowadays 19 private companies that are authorized by CORIs and audited by CORIs by Kayak. But it's part of CORIs to review and pre-approved applications for medical devices and pharmaceuticals. So in, back in 2011, well, I think it's also relevant nowadays , uh, CORIs has had a , a very big backlog in reviewing dossiers and , uh, submitting , uh, sanitary registrations. So that's why they created the third party reviewer entities so they could have more manpower to review and they can expedite the reviewing process. Uh , in 2012, there was also an equivalency agreement signed with Japan. So also the same thing as with US and Canada. Those products approved by Japan and those that , um, can qualify, can have a faster access to the market. Um, in 2013, I know it seems a little bit , uh, too late, but the checklist were implemented. So there's more structure in the way that submissions are being compiled and submitted. There's more structure by ris . And in 2016, there was a new call for authorized third parties . So before you had maybe say four or five authorized parties in 2011, and in 2016, you have now the 19 authorized parties that are helping and contributing to COVID pre or review all and pre-approval of those applications. Medical devices in Mexico are classified by low risk class one , class two , and Class three devices, and they all fall into six categories. Um, and kind of like a difference with other , uh, regulations in other parts of the world, diagnostic agents are considered also part of this category. It's not treated a aside or a as a, as a different regulation. So you have medical equipment processes , orthoses , functional aids like hearing aids, diagnostic agents, supplies for dental use, surgical and healing materials and hygiene products. So three classes in six categories, you know, and we'll be up to your consulting company or registration holder or whoever is in charge of getting market approval to get to know these regulations in order to best classify your products in Mexico, see if they can be grouped or not, et cetera . You know, also it's very important that as in addition to what is stated in writing in the regulation in the pharmac covid , please criteria changes a lot. So you might submit something today that in two years might not be approved because the criteria has changed and there is no communication with that. You know, COVID Peace doesn't do a good job with setting out guides and updating the industry about the changes. And if they do, the guides are confusing, you know, so a lot of this is a case to case , uh, practice. And you know, if Covid pre says something and it's a new administration, then you kinda have to shift a little bit, you know, in order to, for your next products to be able to succeed, you know, in the registration process. Lastly, there are basically three registration routes. One is the standard review process, the second one is the authorized third party review process, which is optional. And the third one also it needs to qualify, is the equivalency agreements . So through this standard review process, you basically, from the perspective of uh , IPS, we would get in touch with , uh, foreign manufacturer, someone who has interest in registering their products. We ask for , uh, technical, legal, administrative and scientific information. We compile that <inaudible> . Of course, everything legal documents needs to be certified by an Order Republic. There legal documents need certified translations, and most of the documentation that is submitted in <inaudible> needs to be translated into Spanish. So here to all of your listeners, the prices of translations into Spanish can really put your project into , uh, different numbers. You know, like translation costs are important , uh, cost of your project. So just be aware of that, you know, if you don't have your documents translating to Spanish, just make sure that there is going to be a hefty , uh, cost in , in that. So after preparing that application, you submit it to covid please and you would get approval in more or less, we would say, eight to 10 months. However, we are always monitoring the approval times from covid, please , which are always changing. Right now in, in Sumos we have an approval of 105 days, more or less business days to get product approved through the standard review process. And we forecast that these approval times of what I said before, eight to 10 months are going to diminish. They're gonna be improved. But we'll see. Right now we're in a different scenario with the pandemic. So we'll see what happens. Uh, the second route to register a product is through the authorized third party reviewers, which I've said before were created in 2011 and then expanded in 2016. So after you have your dosier ready to be submitted, instead of submitting to Covid threes , you submit it to a third party reviewer. The third party reviewer might give you observations, why not? Whatever it's pre-approved, then you submit it to Covid please . And technically you would see a faster approval process because it is technically pre-approved. So the people in Covid police are not technically supposed to spend that much time and should rely on the work of the third party reviewers. That was the case before the change of government, after this change in government with amlo , with the new Lopez Rador administration with the new commissioner, <inaudible> has not been very keen about third party reviewer companies. Nothing , uh, they're supposed to be cases of corruption there. Uh , but that's what you hear in the media, that there are , uh, certain covid police officials or ex covid police officials who have their third party reviewers and that they were favoring applications from those companies. So with this new administration and the backbone of the president that we have now in Mexico is eliminate corruption. So everything that, that backbone has the same operation in all of government agencies. So right now, third party reviewers are not having the same results as they were before with the previous administration. So a lot of the industry is shifting to submit their applications through the standard review process because they say, well, if I need to pay a lot of money for the third party reviewer in addition to all the registration costs , and ultimately the difference in approval times is maybe 20 business days, then I'm not gonna go through the third party route today. You know, it doesn't justify going through the third party route. So a lot of the industry is now submitting their applications through the standard review process because as the new commissioner has said in <inaudible> , he's saying pri so whatever comes in first, will come out first, you know, would be approved first. You know, he's not prioritizing any applications through any registration routes. He's just prioritizing based on when you first submit it to your application. And lastly, the third registration route in Mexico is the equivalency agreement. So you can register your products through the, if you qualify through already approved products by the FDA Health Canada or Japan. And these have more or less the approval times of, I would say eight months. We've seen good results in our experience with 46 business days for approval for a class one , uh, FDA equivalency agreement application, which is really good. So our forecast for 2020 and for the upcoming years is that we will see improvements in covid three approval times with this equivalency agreement route. And also important to note that registration under this route, for example, for FDA products, for Health Canada products is that they require less , uh, documentation. So the overall cost of the project would be less 'cause it doesn't require as much as translations as the standard review process. So that's basically it. Those are the three re registration routes. And in all of the routes, if you were to work with registration holder with a consulting company, is basically determine the regulatory strategy, prepare for market approval, you know, compile all the documentation, submit the application, and just monitor everything to get market approval. And that's when the post-market surveillance phase starts that we also provide for the products that we host. We currently host over 90 products in Sumos hosts over 90 products. So we are very active in post-market surveillance and with all complying with , uh, all the regulations. And also , uh, that's when you request your input permit after getting market approval, and that's when you request your advertising notice or permit so you can market your product.

Julio Martinez: 55:22

Fantastic, Jose. So we are about to end the show. So before we send off for today, OUE , how can listeners get in contact with you and in Sumos?

Josué Garza: 55:34

Well, Julio, we are very active in on LinkedIn, so , um, just , um, you can personally and the company as well, the LinkedIn profiles , um, you can find us there, you can shoot us a message through there. We're also , uh, available on Twitter at za or at IPS mx. And , uh, you can shoot me an email anytime . Feel free please. And my email address is j garza at in sumos para salo.com . And you can visit our website , uh, that is www.in sumos para com . And we're trying to make our best to have both the informations available in Spanish and English , uh, because we are well aware that there are limited resources available for , uh, international companies who look into investing in Mexico, doing business in Mexico. So we want to provide information , uh, to you in , in English and also in the technical terms that the , uh, regulatory affairs , um, professionals use. So you best understand that that is something that is also very important that our team in , in Sumos tries to do. Its best to have the same regulatory first terms that are used globally, because we've seen that if you have a deficiency in communication that can prolong your project, you know , because of miscommunication.

Julio Martinez: 57:15

Okay. Swe , thank you so much for your insights in the Mexican market. I really enjoy listening to your wisdom and to your knowledge about the, the how to get products into the Mexican market healthcare products. I mean , and , uh, how can companies succeed in Mexico? So I'm sure listeners got a lot, a lot. I mean, a lot out of this episode is being one of the longest episodes that we've had, but it was full of , uh, good, good information. So thank you so much and be safe.

Josué Garza: 57:49

Thank you, Julio. Uh, you as well be safe. I hope that , uh, uh, my best wish is for Colombia and also for everyone that is in Florida in the us uh, for your family, for everyone, and your loved ones, and for the population in general. Uh, we hope that

Julio Martinez: 58:08

All right . Excellent. Re bye-Bye. Take care. Thank

Josué Garza: 58:10

You, Julio . Goodbye . Have a good afternoon. Bye.