Unlock the Power of Legitimate Online Signatures for Pharmaceutical Industry in Mexico

How to eSign a document: online signature legitimacy for Pharmaceutical in Mexico

hello welcome to the medical device made  easy podcast here is Monir el azzouzi from   easymedicaldevice.com and today we will  help you to register your medical devices   in Mexico so I have with me Josue Garza director  of business development and operation at ips   and you will help us to make this  so to register your products in   Mexico so Josue welcome to the  medical device made easy podcast oh Monir thank you so much for the invitation I'm  really excited to have this conversation with you   and help your audience get familiarized  with the registration process in Mexico yeah great so yeah we are really we are focusing  a lot on this podcast also on the registration in   europe but i'm trying to pick some countries  one after the other and say okay let's go   now to the us or let's go to brazil or and to  today we choose mexico so let's go to mexico   and see how how people can register their  products produce there so but before that so   can you introduce yourself just to explain  who you are and maybe a bit more about ips   yes yes of course well generally general  overview about myself i've been in ips of   director of business development and operations  for over five years and what we basically do   is help medical device manufacturers and  distributors to obtain market access in mexico   i've also had experience working in non-profit  organizations in the public government in   government agencies and also in the private  sector in a political party as well in mexico   so my background is pretty diverse i have  also a bachelor's in international relations   but ever since i transitioned  to the medical device industry   i've seen a lot of a lot of opportunities there  a lot of opportunities to grow it is a industry   that keeps on giving and it never stops and you  never stop learning about even the products or   the industry itself so it's a very fast-paced  industry evolving constant continuously so that's   something that really attracts me and attracts  the company itself to keep growing and to keep   getting better at what we do and  that's guiding clients in Mexico no I think it's great and you are right I  mean for me also I see that the medical device   industry is growing changing it's there is a lot  of conversions and it's something that is really   interesting also with regulations regulation  are changing every day if I can say all over   the world so we have also to get to keep up to  date and to help those people to register there yeah yes right now with covid we had  to re-learn some well not re-learn but   learn some new things how the regulatory  authority in Mexico which is COFEPRIS   is going to regulate the covid test for example  or how it even is regulating antibacterial   gel or soap sanitizer and so these are  things that were already in regulation   but we had to since those are products that we  don't often register we had to go back and see   how that was regulated and so so it's been a  learning experience even right now with covid yeah you are right so i think yeah a lot of  countries have learned also to be more flexible   within their regulation due to covid because i  mean there is an urgency here to have more tests   or more ppe or more equipment to save lives so no  need to spend too much time in the administrative   things but a bit of time but not too much so  i try to find some accelerated way to do that   okay so let's try to find now how manufacturers  or medical device manufacturers can register   products to in mexico but before that can  you tell us more about maybe the market   in mexico is it more are you more importing  are you more exporting what is some market   share maybe just to understand a bit of  the demand of medical devices in Mexico yeah I think in both it's a mix I would say that  it's a mix between importer and exporter and there   are many data that probably your audience does  not know that I'd be happy to share for example   that Mexico is a top consumer of medical  devices you know like both uh consumer   and exports has grown constantly since the past  five years to grow Mexico is a big population so   it's that's the attractive part as well as you can  compare it in Latin America with brazil you know   it's a big population it has 130 million people  so that is an attractive market for medical device   manufacturers or people coming into Mexico to sell  it one of the largest producers in Latin America   it is it's in the top 20 of exporting countries  in the world it is number 8 i think and it is   number 14 importer countries in the world  it's also within the top 20. so that is a big   mexico is in the top 20s say in medical devices  so that is a very big position for us that is   also the number one supplier of medical devices  to the U.S more or less to give you an idea of how   interrelated we are with the U.S it provides more  or less 90 percent of its export to the u.s market   and it specializes a lot of like dented supplies  even medical equipment so we end up manufacturing   a lot of medical devices that go end up going to  the u.s market you know we don't consume those   like many of those we don't consume but  we make them and we export them and it is   backed up by multinational companies that are  settled in mexico, for example, mectronic bd big manufacturers are located  in the northern part of mexico   they take advantage of free trade agreements  low cost of labor high and good labor   you know qualified labor and that can  manufacture but mexico is also experiencing a   development of medical devices okay you know  it is not happening quite at the moment as   fast and in the government has not backed up  many of these companies you know with maybe some   funds to them to encourage development of  medical devices but there's specifically   some areas within Mexico the country that are  specializing in making these medical devices   so from beginning to end not only manufacturing  certain parts so that's a big change and a big   trend that is happening in Mexico that we can see  in the future may be being something that shifts i think it's great and i think this these are  if i can say good numbers or good situations   so to attract also manufacturers  to sell their products to mexico   if you are i mean we talk about mexico but  there is also maybe other spanish countries   in latin america that can benefit also by coming  to this these region so i suppose there is also   a way to arrive to mexico to be also  going to other countries in latin America yes and no i think that coming to  latin america or to any other country   you should approach it to what  the dynamics are in that country okay a lot of manufacturers try to implement the same  strategies that they implement in brazil to Mexico okay but regulation speaking they're different the  market is different the partners are different   landscape is different so i would have a mexico  approach only you know to have that as a strategy   for manufacturers that are trying to get market  access in mexico and not try to replicate what you   do in maybe chile colombia or brazil you know  i think there are many things in happening in   mexico that are very specific to mexico that in it  might take a while to get a hold of them if you're   coming from maybe europe, the us, from other  countries but if you are looking into a strategy   that is long term and i would recommend having  that approach you know a long strategy for sure now i think it's good i mean it's the same  as if you are registering in europe and in   the us it's not the same countries, not the same  regulations so you are not able if i can say if   you register to europe to go directly to the us  so if we want now to go more deep dive if i can   say in terms of registration so what in the  in europe, for example, you need ce marking   in the us you have different pathway like  510k or pma registration so what are the   different pathways to register your products  a product a medical device in mexico then yeah i think mexico is very straightforward  with the paths of registration there are three   pathways okay one is the standard review process  the second one is the equivalency agreements   and the third one is registering through an  authorized third-party reviewer okay so those   are the three pathways so i'm going to break  them down okay right so the standard review   process is very straightforward you assemble  your dossier that's compiled with technical and   scientific information administrative and  legal information you finish your dossier   and you submit it directly to perfect place  and the review times now since april of 2020   they've been more they've increased right because  COFEPRIS is prioritizing on covid-19 products   and also they are understaffed and there's been  many challenges right now with COFEPRIS so i   would say that to set the right expectations would  be between 10 and 12 months for market approval okay so really i mean for every product or for   low-risk product maybe it's slower  and for high-risk product it's longer well for so in mexico we have going a little bit  back we have medical devices are classified in   four categories four classes in six categories and  the classes are the low risk and class one class   two and class three okay and categories are six  and i know in europe you have ivds as a separate   regulation yeah but in mexico they're all within  the same regulation so you have medical equipment   prosthesis, othesis and functional aids diagnostic  agents so that would be the diagnostic agents   compared to ivds supplies for dental use surgical  and healing material and hygiene products so those   are the six categories right so going back to  your question would it be less time to register   a low risk or a class one yes, in theory, they  would have to approve them in 30 business days   that's what the law says but in  practice that might it's longer   right we know that it's longer but it would be  faster than a class two or a class three device okay yeah i think as you've said also with  the current situation also with coronavirus   i think there is a lot of priorities made on other  products so if you arrive even with a class one or   a lowest product maybe it will take longer because  then there is other priorities in place there   and a low-risk product doesn't even require  a gmp it's a very straightforward it's   more like an administrative registration with  administrative documents if you want to register   a foreign low-risk product then you wouldn't  need in mexico a literal authorization from the   manufacturer to register so that would be the  most complex document that you would have to   request and the lengthiest to obtain you know  sometimes it takes a while to legalize and   do all that process yeah okay and uh is it better  i mean in terms of legalization or everything all   the process of registration so is it better to  just call the ministry of how you call it exactly   COFEPRIS the commission the federal commission  for protections against sanitary risks okay so if second fda COFEPRIS so is it easy to just call them and say i  want to register here are the documents or   you should really be there to  go through the process meet   office number 30 and then go to office number  25 and then go to all these things so is it   really this thing or you can just call them send  them the document email and it's fine it's done so that's one of the things that i think shocks  our clients especially the ones in the u.s that   i think with the fda you have a  dialogue oh i compared to a dialogue   and and there's you don't have to wait until the  end to get the the full review of your application   in mexico you have to submit a good a great  application from the first time you need to   make sure that your application is going to  be approved the first time otherwise you have   to wait all of that review time and then to  get approval or to get requests from COFEPRIS   and when you get a request from COFEPRIS which are  also called as prevencion which is a prevention   the time they give you to respond to them varies  depending on the route that you submitted or the   requirements but it's usually not that long of a  time that you have to respond so if it's something   like a legal document that takes a while to obtain  then you're in trouble right you really have to   work fast to get those documents but to answer  your question it does it's not a dialogue with   COFEPRIS unfortunately you have no idea  what's going on how who's who's reviewing   your application what's happening you just  hope that at the end you get a good review and   obviously if you submitted a good  application it's you have you'll do good so having somebody there is really a kind  of a must you have to have somebody there   that speaks the language and that can  go and help you there immediately so definitely and we have strategies to follow up   with COFEPRIS obviously we  follow the official channels   the channels that are by law you know the ones  that you should follow applications if there's a   delay then we follow up with them until it gets  approved because that's what we need approvals exactly and i know that for example in europe  you need a authorized representative you need   an importer the same in the u.s  you need the u.s agent etc so   do you need the same thing in mexico do you need  specifically to have somebody that represents you yes yes so international companies that  want to register in mexico they need   to have a legal representation in mexico and  if they don't they can register through a   registration holder authorized representative  in sumos ips is one can enact as a local   representative for international companies  and that also gives us a big responsibility   because we look after the surveillance  once the market the product is in market   we are entitled to look after the product no so  we do that in collaboration with the distributors   and with the manufacturer you know it's not a  one-person job it's a collaboration between all of   the companies involved basically the manufacturer  the registration holder and the distributors here   the manufacturer can name as many distributors  as they want so that's very good because they can   diversify and if one partner does not prove right  then they have others that can make up for that   or they can change the registration and eliminate  distributors and then put another one that   will hopefully prove better in terms  of sales and marketing but yeah it's so it's better than to not take your  distributor as your legal representative also that is something that the manufacturer  should answer you know and i mean we've   seen a trend from our own clients that they go  in other countries or other continents africa   asia through distributors okay and they have  had bad experiences because the relationship   goes sour and then they are not able to get their  registration you know the owner is a distributor   so they have to re-register or they have it's  a loss of time and of money and resources right   so there are many of manufacturers that do choose  to go through a distributor in mexico and they   have a business settlement there and whatever it's  right but we recommend going through an authorized   distributors for sure because that gives them  more flexibility into what partners they choose   it diversifies their opportunities you know  you don't have all the eggs in one basket   you diversify them and have more opportunities  there and also your registration is safe with   us you know you can say i want to change this  distributor i want this that no and and we do   it on your behalf also distributors in mexico they  have they're good you know they get the job done   some are specialized in the public sector some  are specialized in the private sector some both   but we've seen that they lack that regulatory  expertise so if you're going to a distributor   most likely they won't have a regulatory affairs  team to get your application in COFEPRIS approved   in a good time you know so there would be  a struggle there in the regulatory aspect   yeah it's also something that we are recommending  here in europe so there are also some people that   say oh can i take my distributor or my importer  as my authorized representative and i always say   i prefer you don't do that because if you  have an issue with them then you have to   the the thing is that you have to  place their name on the product   so if you have with them you have to change  all your packaging again to change the name   of the products and everything which is  a nightmare sometimes so yeah so it's   also something i recommend here in europe so i  would recommend the same then in Mexico to go yes yeah it's highly recommendable for sure  yeah it'll be easier for sure and the other   registration routes we stopped at standard  review process but the other registration routes   are the authorized third-party reviewer  which is basically you finish your dossier   okay also bidding to COFEPRIS you submitted  to a authorized third-party reviewer which   are authorized by COFEPRIS okay as external companies private  companies to review and pre-approve   applications so you have i think more  or less like 19 companies like this okay and they focus in pharmaceuticals and medical  devices so you send that application they   usually review it in 15 days and then  you submit it to COFEPRIS pre-approved   so this used to be a great option okay in 2016 to 2018 more or less you know you would  get a class three approved in three months   okay even in 2018 we had a class three it  was a stent approved in 30 days okay it was   incredible you know just because they went through this company  that is authorized so it's because there is   a good relationship and this is working well so  they are trusting those type of companies more right so these authorized third-party  reviewers they're audited by COFEPRIS okay so they have to follow a certain standard  and quality system you know that is aligned   to COFEPRIS and they used to have meetings  between third-party reviewers and COFEPRIS   while your application was in COFEPRIS to take  care of any things that needed adjustments or   any complementary information before gave  you your approval or not so that was a good   way of collaborating and technically  COFEPRIS had to train the folks in the   third-party reviewers to align criteria right  and in 2018 in Mexico we changed governments oh so we have now amlo and with this every  changing government there's changes in key   administration areas and so the head  of COFEPRIS changed and with that many   of the how we used to operate in COFEPRIS many  of those criteria's processes changed completely okay so from 2018 to now it took a while to  COFEPRIS to get traction it's still in the   changing process i mean we're in 2020 and  it's still changing it's still not adjusting   but they are not keen to work  with third-party reviewers okay so from late 2018 up to today submitting  through third-party reviewers is not advisable   because the review times is taking more or less  the same time as with the standard review process   so in terms of an investment in time and  results it does not make sense for us to   advise our clients to submit under that route  because they would be investing more resources   because they have to pay for the pre-review with  the third-party company and the time to market   is pretty much the same as with the standard  review process so that is something that has   made it longer and more complex to have in  terms of time to market with our clients yeah so i imagine as you mentioned that yeah  the different political situation can always   come and put some troubles i can  say in the registration process   but in terms of the registration  then you as you mentioned so ips   is able to help medical device manufacturers  for that in mexico so what does mean ips again oh ips is in sumos para la salud and  that literally means health supplies okay right so in mexico you have the regulation   and for pharmaceuticals and in  sumos para la salud regulation which   basically encompasses all the other health  supplies which is medical devices and yeah okay and so ips how are you helping  and as you've said you can be the   authorized representative you can help for  the registration so how is it working then oh before that let me just finalize the  third registration route okay which is sorry agreement the equivalency agreement so if your  product is approved in the fda health canada   and japan then in if you qualify depending  on the criteria of the equivalency agreement   then the documents that you require to register  would be less yeah and the time to market   is usually eight months for registering  through the equivalency agreement route so fda canada and japan it's no   brazil there is no europe there is no  all the other countries only those ones no yes exactly but also if you say you have 510k  in the u.s well yes but you need a establishment   inspection report so that's the conditions and  many manufacturers don't have that you know they   have the 510k but they don't fda hasn't paid a  visit to them so that's a requisite that they   require to register through the equivalency  agreement route or post-market surveillance   report for class two and class three they need to  put their adverse events and call history records   so those are things you know that kind of not  all products that are approved through fda health   canada or japan can qualify under this route but  we obviously take into considerations look at the   information that they give us and see if we can  prepare a strategy to register through that route i think it's good so i as you've said so  i think it's important to have an expert   an expert in the different routes and to really  guide those manufacturers instead of them spending   a lot of time to maybe go through the wrong  route or to spend a lot of money on that so   and as we said so ips can help  for that so what then can you do yes so we like to think of ourselves of  one-stop shop 360 regulatory consulting here okay we understand that there are certain aspects  that happen before you decide to register okay   during the registration process and during the  post-market phase so that's how we break it down   so in terms of our solutions we have market  intelligence for clients specifically in foreign   clients that they don't know much about mexico or  they want to see what price point they enter with   their product in mexico for example which are the  key players benchmarking so we have a service of   market intelligence with our ally brachmatic and  we can deliver qualitative and quantitative data   market research information for our clients if  they want to request that so that's that would   be one of the services we also obviously  are our bread and butter as they would say   is a regulatory strategy and submission so we are  we don't specialize on one category or one class   we have experience in all of them  and we can prepare new registrations   administrative modifications technical  modifications and renewals so for all classes and   categories we prepare all of that and we submit  it to COFEPRIS follow up until it's approved   that goes hand in hand with hosting and post  market surveillance so if you appoint us as   your authorized representative we make sure  also to do the post-market surveillance space   and submit the renewal when it's you know maintain  the registration COFEPRIS if they have visits they   visit us so we represent you before COFEPRIS  etc. and we also have logistics services such as   imports permits and distributor search and  screening a lot of clients from worldwide they say   we want to register but we need a distributor  we don't know who those key players are   mexico does not have a database of distributors  and we have a distributed search service so we can   pre-screen some of the potential distributors that  they might be able to work with the manufacturers   and we of course look into compliance with  COFEPRIS you know basic compliance with   COFEPRIS such as like their operating license  you know do they have one do they have the   scope also to be able to distribute the specific  medical device that you want to distribute their   experience in mexico on track record that's  very important to us not only to recommend any   distributor but recommend these services  that comply with the existing regulation   and we also have a service that's focused on  advertising so COFEPRIS also regulates advertising   so whether it's advertising permits or advertising  notices depends on where the product is going if   it's going to health professionals or  to the general public and we also have   allies one of our biggest allies is bioana which  is based in monterrey and their focus on design   and development so say you want to design a  prototype of a medical device and you want to   explore elsewhere and maybe lower your  cost with high quality work then we would   point you to them to have that concept  development engineering team they're great   we really like them great yeah so that's pretty  much all of the services that we can offer   to our client to our clients but our  bread and butter is regulatory at first no, I think it is great as you mentioned one-stop  shop for all those things so it's really a great   one so yeah if you are listening and you are  really interested to register your products in   Mexico then contact Josue Garza from ips he will  try to help you I'm doing that and investigate if   you need this support or this service so Josue so  you are as I said you are really working on the   Mexican region so is there any other regions  that are really also in the scope of ips yes well we have certain partners in central  america and that partner that we have   looks at central america as a region as a whole so  they have that advantage instead of just nicaragua   el salvador you know which in terms of market  size is not very attractive but if you look at   central america as a region that might be  better as a strategy you know so we have a   partner there and also in colombia it's for  products that you want to register in vima we can   point you over there in brazil we have a couple of  partners as well but of course i mean what we try   to do is help our clients as much as we can you  know but we really want them to have a successful   experience in mexico and with the partners that  we also have in those countries in latin america   but for us having a good successful and easy  experience for registering is very important to us   because it's important to us to put ourselves in  our clients shoes you know there are many unknowns   they even sometimes don't haven't  had a chance to visit mexico   so it can be their ears and eyes  and experience consultant for them   and provide them peace of mind during that  whole process then that's a very big win for us great so really great thank you josue for that  i think it provides really a lot of value for   the people that are listening so yeah if you are  really interested to go to latin america i think   josue will be your guide he can find you the  right places to go and to to help you on all   the process okay josue sorry thank you for for  that thank you for your help for all the people   that are listening to this podcast so don't  hesitate to go to your podcast provider and   to provide also a review just to tell that you  like this podcast and don't also hesitate to go   if you are listening if you are looking at that  on the youtube channel to put a like and also   to provide a comment if you have any comment  i will send that to josue so that you can   answer to you so okay so thank you josue really  appreciate to have you on this on this episode   and i hope really that people will contact you  don't hesitate it also to go to the show notes i   will put a lot of information so that you can also  contact josue so that you can reach out to him and   ask for his support okay josue so thank  you very much and i wish you a nice day oh thank you so much Monir have a good one.