eSignature Legality for Pharmaceutical in Mexico with airSlate SignNow

How to eSign a document: e-signature legality for Pharmaceutical in Mexico

alright let's get started hello everyone my name is Priya bhutani thank you for joining us today the goal for today's discussion is to give you an overview of the regulatory process for medical devices in Mexico for those of you who may not be familiar with reg desk we are a machine learning platform for regulatory that makes global compliance easier and faster break desk is the trusted regulatory intelligence platform for many of the leading medical device companies around the world we are happy to discuss offline how men tech companies are using AI and regulatory to get and stay ahead with us today we have a leading expert from Mexico Rebecca Estrada Rebecca Estrada is a regulatory affairs expert with over 20 years of experience in the medical device pharmaceutical and cosmetic industry in the past miss Estrada has worked for organizations like fizziness medical care and leading pharmaceutical companies her vast and extensive experience includes technical dossier preparation regulatory strategy across not just Mexico but the entire Latin Latin region implementation of quality management system and also audits Rebecca owns a consulting company in Mexico City focused on helping foreign manufacturers obtain Product Approval from Coca press and she has worked with wide array of medical devices as well as in vitro diagnostics so she's the perfect person to have today but before we begin our discussion this morning I'd like to turn our attention to our attendees thank you again for joining us at the end of this meeting will hold a brief Q&A we encourage your participation and when we say participation since this is not this is sort of a different type of webinar in which we're giving the overview of device regulations and not just the up the upcoming changes please provide your input and and share your experience that you may have had with coffee press that would be very valuable also please refer to the chat feature button on your screen in the interest of time submit your questions throughout the course of our talk and we'll try to address as many of your questions as you can otherwise we were happy to send you an e-mail and address those for you also we'd love to get your feedback on today's webinar and any ideas you may have for future webinar topics I will send a short survey post webinar to your email and again we'd appreciate your feedback well let's get started Rebecca welcome it's a pleasure to have you here today thank you thank you Priya thank you everyone for connected to this webinar and well I'm happy to be here and share my experience with covered bridge with you wonderful so you know let's start with the basic about classification because that's the first question is understanding how products are classified so how are they classified in Mexico do they follow us classification rules or your European Union's classification rules and or do they have their own rules well Capri's does have their their rules for product classification but they're most based on European rules because the classification is for class one two and three but there's no +28 or 2b and the classification is based on the time the product stays on the body that enters to the body and the risk of the of the product if for example it's a product is in the body less than 30 days is considered class two and in this hour 30 days it's considered class 3a so that makes sense so it's a bit confusing in that the rules are similar to European Union because of its depending on how long the product is in your body orifice however if they don't have concept of two A to B it is one two three similar to us nomenclature moving on a lot of our viewers are IBD manufacturers as well so can we can we also quickly touch upon whether IB deeds have separate classification system for the IBD there are no special classification there follow the same rules and also their most held a IV DS generally tend to fall in the class 2 category because they are separated like by the specialization required to manipulate a diabetes if there need to be specially trained or or not okay so part of medical device no special requirements or law or rules around IBD classification so that's clear and so now now we can proceed now that we know device and IV DS will have similar approval process moving on to the approval process you know we understand there are a couple different ways to register products pathways in Mexico can you tell us more about what those two pathways are and how do they differentiate yes well there is the traditional pathway and this requires all the technical legal documentation they required the Quality Assurance documents and the manufacturing process etcetera and there is the aggregated pathway this is more for the countries that are to have an agreement with cooperate for example a u.s. European Union Australia and the and Japan and this is another way to present this here that requires a little less document but sometimes it's supposed to be faster but in the reality sometimes they don't comply with their with the timelines to obtain their registrations these are another way to present the information but not always is a better got it too so the two methods as you mentioned are abbreviated and traditional so the idea of abbreviated method if we understand correctly is that as long as you have approval from one of those ght F markets though it's not called that anymore then then you can go through it it's supposed to be faster but it's really not faster and then you have the traditional pathway which is supposed to take 8 to 10 months but the traditional route now speaking of does so in the US the FDA is on you know they have a timeline they have certain amount of days that they have to respond to the clients is that does for the abbreviated pathway to cope oppress reviewers not have such a time clock do they is that why it's not is it not mandated that within three months that they should respond yes tech coverage does have those timelines day it should be like one month or sometimes three months but the reality is that sometimes it takes longer and may be because of the load work or another situations they don't follow the timelines so this is something to have in mind that a sometimes appropriate weight is and not really there the faster way god so so that's that's clear that's good information to have and in the chat box if anybody wants to share their experience with the abbreviated pathway we'd love to hear from you and then then obviously there's our traditional but coming back to abbreviate it just real just curious so abbreviated pathway is not class-based so if I've class two or three I can even with the class three I can go through abbreviated pathway is that right yes you can submit any class from one to three and there's no difference with the with the submissions although as long as the manufacturer has all the documents they they can submit their they any class got it and now this submission we last time we discussed Brazil and they have a new electronic portal system does Mexico have that does coca press have an electronic portal through which you can submit applications or or is it a physical copy that you have to bring physically to coffee press yes that's an electronic way to submit their the OCR but really in the practice it's preferable to present hardcopy physical copy of the dossier and to present it directly to the coffee press offices and this is more like the regular way there very little our authorities or manufacturers a presence their toes here by electronic media got it and then do you have to request an appointment with them or is it is it flexible or do you have to schedule an appointment ahead of time to then have your legal authorized agent physically go in and and present the copy or is it sort of a something you can just mail because in with you after you can ship a hard copy oh you used to be able to ship now they have photosystem two but nonetheless I mean with hard copies are we talking about just being able to ship them or do you have to physically request a meeting an appointment with them yes the the most common way to presented us here is to get an appointment a to cover press offices they have their this ceased they call exists there is um center of General Services and they you can you can request a debate and an appointment sorry and they do 10% not only one to share you can present a many those years as long as you mentioned that you will be presenting a more than one and it an authorized person something in this legal representative of the company they go to conference with a those shares and they submit true disease and they give you a code number so you can track their the application online got it and about the let's go about over the third party so the we understanding here that there is a concept of third parties it's not the same as notified bodies that in European Union can you can you tell us what what is the role of the third parties and how can manufacturers use yes well this figure of third parties they don't have much time they have all like five years a function in home for for this activity and the function is to review the heirs and present to the matter to a manufactory if there is a inaccuracies or they're missing some documents or suggest some changes some changes and to make the dessert is ready for submission and after the third paragraph used a dossier they issue a closed letter to Caprice and this learner has to be presented by the manufacturer with the dossier F at the time of submission and this letter is like like previously approval of day of the dossier and if the in the bread case that Caprice has more doubts or a have some questions they called a third party that was the one who tributed to see her first and they ask for for clarification it's not necessary how is that the manufacturer is present at the time of that clarification is more like between the third party and Co Fabrice because well the third party is authorized by Caprice and they well they don't need the presence sometimes or from the manifest okay got it so so that's good to know and did with the third parties so which is it can use use third parties for both abbreviated and traditional or is there are there limitations or or can i if I've abbreviated or whichever method pathway I use I can use third party review the third parties work only for traditional submissions they are not accepting the abbreviated way and the time with them third party sometimes short terms two three of four months for the approval of Caprice plus the time that day preparing evaluates they they don't yeah so it really is a good option if you look for for get a faster approval from Caprice okay so that's another reason why I'm I'm assuming that clients may opt to go the traditional way because then you have you can utilize the third-party review and it's probably faster it's because they so now once the third-party review just want to touch upon some questions on this topic before we move on so with the third-party once they submit a letter and you submitted to the copper to copper press what happened so who submitted so the reviewers will review the application then once it's submitted to co-present they have the evaluation by the third party does Kofi press review the application or are they just basing approval based on the comments and feedback from the third party yes well then the manufacturer does have to submit a dado share and the application and coffee please takes the word for from the third party but does a noble review of day this year along with a with the valuation of their of the third party so they can be sure that no no no problem is with this year and after that they taste grant a the registration but this is why the time is shorter than the iteration away because the iteration oh wait it can take up to more than a year so if you compare there is a really substantial differences you do everything that the third party got it okay and so but regarding the fees you would still have to pee Coffee presents fees and and and third-party reviews an additional cost that has yes there is a difference coast apart from the third party because the third party our private institution and take off a breeze our fee is apart got it and so regarding third party so let's say I'm a manufacturer I use the particular third party I'm not happy with their feedback can I change third party are you allowed to change a third party because it's private institution or do you have to stick with the same third party now you can there's a list of of third parties in the Caprice website so you can choose to the third party that is more suitable for you and well they only think that for example date you can't have a copy or captain or keep a copy of they they inform from their server honey to go for breeze but just request a change any time a third party got it and you could use multiple third parties for different types of product registrations yes so maybe you can hire some third party for one a specific class of device and then for another you can try to submit it with another third party there's no no a special requirements for that okay got it and then you know we skipped a basic question about is local in country representation required so if you are a foreign manufacturer you do require that you need to have a legal authorized represent representative in Mexico well yes previously they need to be an established company in Mexico but from some years they're accepting that they have our house if you the company have warehousing the in the country in Mexico they can have the authorized or their liquor representative and then submit to to go Febreze got it so so it is required to your legal authorized agent must have a warehouse is that if you don't have a warehouse so for instance if you in your consulting firm do you do not have a warehouse can you not represent someone in Mexico it's more difficult because well for the the imported a makeup device you will need to someone that is in charge of that and it is easier when the the legal representative son has a our house and yeah it does keep score princess certainty that there are no like phantom Enterprise a phantom company like because sometimes it it can keep appraised impression that the company is not very serious or there it's in my experience is better that they they have our house they have a warehouse because then because the warehouse then they can physically go and inspect and so they feel that that it's a real entity understand I got it so now let's move on I know we don't have too much time left but you know what I we always like to cover what is the hardest or the most complex part or let's say the process of getting approval once where do foreign manufacturers in your opinion struggle in Mexico well I've seen a lot of requests from coffee place to clarify or to percents the correct legal documents and there is some very simple part of that of syrup but sometimes the companies does not represent a correct documents or sometimes they they are expired or simply they are not translated into Spanish for the legal documents they must be presented in Spanish translated but by a specialized translator and sometimes even is a very simple thing they the manufacturers don't press enter these documents and also the other information that is presented in the desert if there is in another language it has to be presented also in Spanish for example de Quality Assurance or testing data this has to be presented also in Spanish a sometimes the information is not clear for priests sometimes they have no they have some doubts and they request more information or clarification for for this information got it and actually this is a segue into a question that just came up which is related to some of the of this so the question is there's a UK manufacturer and their products will be sold as UK products but their Factory is based in in China and they have an OEM agreement with that with that facility in China coca press is requesting that this manufacturer provide more documents because ing to Kofi press the documents with the factory name and their name is not matching so what do they do because the factory won't be in their name because they're using a contract manufacturer to to manufacture their devices so how do you have an idea I mean again you can think about it and we can get back to the client but the question is what can they do if the if the names don't match yes well you can this is very specific but you can present an agreement for manufacturing so were you saying that a QR the owner of the of the product part you are requiring that other company manufactures the product so this is a a way to solve the situation and as long as you include this contract in this Agreement a you can support that - you have cured the owner of day of the road got it well they said they've done tried that but but coffee press is rejected it so they're sort of stuck in this really bad situation where again maybe you have thoughts after after this and we can discuss this but this is a very valid question but this relates to write the lead the names not matching up and these are the things that caused the delays yes the cover briefs they need to be sure that the names are matching and sometimes even the certificate of analysis they don't match sometimes a batch codes or the company's name or something and they do have questions today to the manufacturer so these are very important points that all the information to the 2-sphere is it's the same that because sometimes the information is presented and the company does have a change in their legal name or something and maybe one document is issued to to one legal entity and then the final name is different so it yes is very very important that the information is sustained through those here we got it so then if what if what happens if you keep running into the situation where they're not accepting the documents is there is there any other way that that can that a client can yeah well sometimes Caprice dots have appointments with a manufacturer's there are no common thing it they do accept a request for technical appointment so you can explain the in more personal way there in the situation of of the documentation so maybe they can try to request a technical appointment and to ask Caprice exactly right they're required and why either require in this way got it and then another really good question is about an visa documentation so if you have approval in Brazil within visa can you can you register is there is there a shorter pathway if you have registration Brazil to then transfer that over to my to cover Chris well I think that the the agreements are getting from open to more countries a I'm really not sure if I'm besides already a approved they they were I think they were working on the on the a matching of the documents or something but maybe I can look for for my information so but so but and real quick just your parting thoughts in terms of what can we expect from its core purpose working on what what are they working on what's what's in their pipeline what are they focused on what types of changes can we expect so it looks like this is one that that if you are if you have registration from other countries within South America that that there's you know harmonization of these documentation yes sometimes well right now go for braces in a in a transition process because of the change of administration with the new government but right now they main focus of the is to provide and general access to to healthcare to all day the Mexicans and coffee breeze will be a part of this by carrying the registrations that are behind and the new and for new products also so there will be working on these authorizations and maybe they can reevaluate they or continue with the harmonization with another countries for created more aggregated ways of a doubt they ever been with works former countries so this can be also a way to provide they they general access to their to the public for for health care products so I don't discard that this the point for working all day on the next year's got it well we are out of time in fact couple minutes over I want to thank our viewers our participants again thank you for a great discussion for asking great questions and thank you so much Rebecca I was truly pleasure speaking with you today and then thank you for providing insight again for our viewers we will follow up with you with a very brief survey your feedback is vital so please take second out of your schedule and give us some feedback and we look forward to speaking with you again soon and in actually before our next webinar we will will notify you that we will be holding another webinar about regulatory automation because we get that question a lot how do you automate your regulatory intelligence and your internal processes do you have that so we will be hosting that soon and you you'll learn about that very soon but thank you again and everyone have a great day thanks Rebecca Thank You Bree and thank you everyone for connected thank you thanks take care