Patchwork or Pathway? Navigating Regulatory Fragmentation in APAC | LSI Asia '25

Gabriel Sim  0:05  
Hi, good morning, everyone. You see that I'm the only one using the handheld microphone instead of the earpiece, and that's because I'm wearing hearing aid. Yeah? I mean, we are in the med tech industry, right? So we have to embrace medical technology, yeah. So a little bit about myself before I move on to the panelists. My name is Gabriel. I am from APAC Med, which is short for Asia Pacific Medical Technology Association. So we are not for profit, Medical Technology Association that represent companies operating in a region, medical device diagnostics and digital health companies operating in a region. Yeah, so today's topic is really, really important topic, because one of the mandate why this association was started 10 years ago, was that, you know, given that Asia Pacific is very fragmented, there are different requirements and regulations. You know, the mandate for the association is really to drive the harmonization and the conversions of policies and regulations. So today's topic is really, really, you know, important for our industry. So just to set the scene before I pass it on to the panelists, is that, you know, number one in Asia, Peck you know, it is an important region for Medtech innovation, undoubtedly. But of course, you know, there are significant, you know, challenges around regulatory fragmentations, yeah, and this could pose, you know, significant challenges to companies, whether they are startups or MNCs, who are trying to scale and grow their presence across the region. Of course, there are ongoing efforts to, you know, try to harmonize the regulations across the region, which is a good thing. But I guess the question is, you know, is this enough, and where is this heading? So today, I'm really, you know, delighted to be part of this session, and I want to introduce my panelists here, first of all, on my left is Carlos. Carlos is the co founder of lirap system, and Julia is the general manager for the clinical consultancy Research Center. Yeah. So maybe to my panelists right to kick us off, maybe if you can introduce yourself, a little bit about your organization, and maybe also share with us, from your perspective, what does regulatory fragmentation means to you in the Asia Pacific region?

Carlos Granada  2:31  
Julia ladies first, yeah, okay, thanks.

Julia Yuan  2:34  
Thanks for having me as a panelist here. So actually, I'm Julia Yuan from the CC RC and this company, and also from the IB dialysis Company, founded in Shanghai, China, and also, as well as from Taiwan. And our company, is helping the medical device company to plan their business strategy model and to get a salary of the regulatory pathway to to in, to shorten the timeline to get as many as country clearance from the regulatory body and from the QMS from the beginning, from the end to end, service our company can provide. Thanks. Nice meeting. Great.

Carlos Granada  3:18  
Nice meeting you. So my name is Carlos Granada, yes. I'm the founder of lira system, which is a software that we are developing to accelerate clinical trial. STEM lines is a company part of the portfolio Med, which is the brain company. My own experience in the me for the last three years, I've been co founding companies. I've been in the clinical site level, Croix and Clinical Strategy, clinical strategy. And he's, I'm thrilled to be here and sharing our own, you know, knowledge and lessons learned.

Gabriel Sim  3:48  
Yeah. So how does the regular I mean, what is your perspective of the regulatory, you know, fragmentation in this part of the region, in Asia, Peck, you know, based on the work that you are doing, you know, with your clients in this region,

Julia Yuan  4:03  
from our side, from the regulatory approval part, I think from our side, that means we need more manpower, and we need we do a lot of repeating works. So that's the challenging piece, and also the language in these Asian countries, there's so many different countries, so that means not like Singapore is official languages using the English is much easier to prepare the dossier for the regulatory bodies. But for considering, if you enter into the these Asian countries, we have to, you know, translate into the local language, and that means require more manpower local agencies to help us to do that part work. So that means more time consuming and then more cost.

Carlos Granada  4:54  
Yeah, yeah, I define as and when I go back to Europe and. Basically us in the past. Today, I see the inconsistent rules. What that means is, you know, delays, you know, rework, you know, manpower and basically that really swift shift into extended timelines. And that's a challenge for startups, but also for strategic you know, to say what is going to be my strategy, how I'm going to do it is Japan, first, is China second, you know, how we're going to do it. So that's how we see the fragmentation.

Gabriel Sim  5:27  
Yeah, right, okay. Do you have examples on, you know, in the process of supporting your clients? Right? Examples of clients and all, you know, two countries having different regulations, you know, how do you go, typically go about supporting your clients who is trying to maybe get into a certain markets, but the regulations in two countries are different.

Carlos Granada  5:49  
Yeah. So maybe one example that I give in our own case, Australia, for us, is being the number one because we see a faster path international regulations or approvals Europe, is really straightforward, but also we understand is okay, what is going to be our strategic plan is, is a reimbursement strategy, is milestones based into the for the next funding round, because the Japanese market is really important, but it's a really time consuming and documentation China is is, well, the biggest market is another war. You know, we need a local partner to do it for us. So is is, yes, but I have access specific samples. In Australia, it took us less than five months to really get approval. In Japan, it was like 12 months to even just get the final negotiation with the PMDA, yeah, so that's when you start balancing. Okay, where should I start? First, you know, and start ups they don't have and we don't have enough capital. We have limited resources, so we need to be smart as well, how to do it and where to go.

Gabriel Sim  6:56  
Okay? Julia, yeah,

Julia Yuan  6:57  
so from my experience, actually, how defining you know which country to go first, and then, normally, you know, especially in the past years, most of the companies probably have business strategy model starting from the western side, for example, US and European country. And then now the European is transitioning from the MDD to MDR. Another delay, another delay, another delay. So now you know so many company comes in mind and to find another way, another round, another pathway, to accelerate their product launch the in the other country. So, but if Asia itself, you you probably understand in China, they launched a new policy since back to the 2013 so there's more restriction, more data requirements, but you know the difference, the difference between the those countries, but we still can find the ways. For example, the EU you can, you can confirm that your company strategy from the beginning of your product designing. So once you design for that, and then you counter in mind, which target country you want to go, then you considering all the requirements from the regulatory body, from the perspective and from the designing standard perspective, and then you can come faster, and then, you know, easily, to get approval. So that's things, you know, you probably from the beginning. Now, for most of the time, the customer, the client, come to us is already in the late stage. They say, hey, I want to go this country, and I want to get a register, but they didn't consider it back to the product design. And then they have to modify a lot of things. So, yeah, that's the things you always need to consider in my

Gabriel Sim  8:46  
thank you for setting the scene. Of course, I think the time, the cause, you know, critical factors, right? Yeah. So maybe let's focus on, you know, diving deeper into the patchwork of the regulations right now, right? So, so obviously, we know, based on what we just mentioned, right, there are obvious challenges of the of differing, you know, differences, you know, across countries, and what are some of the, you know, maybe less apparent, but significant hurdles that you know, regulatory fragmentation creates, I mean, top of mind, thinking of like innovation talent, you know, but from your engagements with your clients, right? What? What are some of the other hurdles that you know, you know that regulatory fragmentation might cause for these startups,

Julia Yuan  9:35  
for staff. So I think the fragmentation, I think the most hurdle has been cause is, you know, they don't they have a very lenient meetings. They are not like MNC companies. They have so many affiliate or subsidiary in each countries, they have sufficient power manpower to do the work and for the fragmentation, especially different country for the. You want to launch your product, commercialization your product, for example, you need a local sponsors. So for those really stuck company, they have very LinkedIn, probably only the team in in particular countries, and then they don't have the manpower in the target target country want to go.

Carlos Granada  10:19  
So yeah, and I can compliment that, you know, which is really a struggle in the companies, is limited resources. Yeah, that's, that's really a pain point, because when, when a strap really they need, and there's a really famous face, time is money, and if you don't move faster, uh, others gonna do it, right? So, so really is to to complement Julia's point is, what is the strategy? You know, am I just collect data, just to go to the next milestones, or I'm gonna include my reimbursement strategy to validate the future plan to enter in a larger market like China, US? You know, I think every strategy is different, but, but limit resources is one major pain point, because when you start saying, Okay, send me the investigation brochure, let's review that, and then translations and all that. So this is start getting time. Nice time, nice time. Night. But one, one major, major issue that I have found in all these the years is quality management systems. I believe, you know, as a entrepreneurial you need to think always is, what is my design history? How I need to document this, how I need to defend my position in terms of regulatory bodies or or the agencies, because that's a major request in terms of documentation. So if you don't start in the beginning with that documentation, when you are ready, basically you are not ready. And we have seen that a lot doing gap analysis, doing reviews, and every country is going to request you different information.

Gabriel Sim  11:54  
Okay, yeah, so you mean good that you mentioned QMS. I mean, I think QMS doesn't come, you know, readily to the startups. It's not top of mind for them. Yeah. So, based on your experience working with some of the smaller companies, right? Do you see them adopting QMS at the very early stage, or is it really an afterthought?

Carlos Granada  12:18  
I think it's after,

Julia Yuan  12:20  
you know, they need education. You need a lot of education. And yeah, definitely

Carlos Granada  12:26  
is like, I believe the concept is there, yeah, but the time is not there, right? Maybe the expertise is not there. So I believe, I have seen companies that, when they said, okay, my design is frozen, I'm gonna do it. You said, Okay, how you documented the pass, how you documented the version control, how you did it. Oh,

Julia Yuan  12:46  
oh, yes, have any top going.

Carlos Granada  12:49  
So that's, I think, my main, main challenge, and I suggest, I mean, my recommendations, always start documenting, start documenting, even in a framework that you follow. But you don't need to have certification, 13, 485, no, but at least you follow the structure, you follow what you needed, and then have experts to help. Yeah,

Gabriel Sim  13:08  
yeah, yeah. Carlos, I just just wondering whether you can talk a little bit more about the platform that you have, that Leah, Leah system has, I guess my question is around, you know, cybersecurity, you know privacy, you know health data, and you know, how do you typically deal with sensitive you know, health data, no part of your work. Yeah,

Carlos Granada  13:33  
yeah, we found this, this need, based on what we discuss is there's a lot of fragmentation as well. In technologies. There's a QMS from one side, TMS, CLINICAL TRIAL MANAGEMENT SYSTEM, EDCs, you know, but they are not interconnected. And when we finally said, let's make it simple, for companies, they had one system that integrates all these components in one one username, and passport, and that's it. And to your point is, let's validate this global, but we know we need to adapt it per country, so that's what we did. So basically, you know, we said, okay, mainly the US is the main target companies to enter. But also we need to adapt GDPR, we need to adapt to TGA. We need to adapt it. You know, Singapore, you know, because every single country has their own adaptation health rules. Yeah, us is really, really strong. So we, we have to do a lot on cybersecurity, testing and, you know, HIPAA, which is phi management, is top. You need to follow a lot of that, especially because when you are dealing with a institution in your contracts, basically, that's a big, big language, and if you don't comply with that, you're going to be in trouble. So that's something that is going to be more required for devices, because more. Are connected, you know, to different wearable devices, sources, and that's going to be a big challenge. You don't prepare that in advance.

Julia Yuan  15:07  
Yeah, right, yeah. And especially country by country that requirement are different, especially for QMS and for the data protection. I can talk about more about China. See, the China is the other one the data protection. It wouldn't allow, you know, if you are the AI based or software as a medical device, they wouldn't allow the data to be transferred out. And then, same as a European, you have, you know the data protection law as well. So right now, how to protect the you know the to prepare ahead. For example, you want to collecting the data on the cloud base, probably you have to have a when you designing the product and building the products, if your target country is China, and you probably think of to having the separate server in China. So that's sort of things you have to plan ahead.

Carlos Granada  15:52  
Yeah, and that's that's true, because Australia is the same, yeah. You know us Europe, they had the data privacy framework. You need to self certify. You need to do you need to maintain your SOP. So it is, it is a global need, but you don't need to miss the local

Julia Yuan  16:13  
record. Yeah, it's more restricting right now for React.

Gabriel Sim  16:16  
Actually this data localization, I think it's also an important factor as part of the region, yeah, especially when it comes to harmonization. Do you have any thoughts around, you know, data localization, whether in the region, or if you have examples outside, the outside? APEC,

Carlos Granada  16:36  
so look, for example, we have been involved in projects that is US, Japan, by the harmonization, by doing program that helps, but still, you need to be local based. So still is a global program is still helps on timelines, but the process to plan that takes time. Yeah, negotiating with not only FDA and PMDA, but also the investigators. Takes time. For example, if you are going to access in the US with a device that has, I mean, over the wire, but in Japan, no, so you okay, how we're going to manage the the process, how we're going to enroll the patient, how we are not going to deviate in the US. But yes, it's accepted in Japan. So all those situations are the challenges. And then, you know, at the end is how we manage the data. Because in these cases, let's assume you have an adverse event, and the Committee of events, you know, to manage those adjudications is in the US. You need to transfer the data. You need to do that. I mean, there's no another. So basically, you need to put in place local servers, put the framework to accept the data to be transfer, and that's going to be a challenge, and especially in contract management. So there's issues, but it still is possible.

Julia Yuan  17:52  
Yeah, the data sharing among the countries, I think these big issues, it's not quite open yet, country by country.

Gabriel Sim  18:00  
Yes, still on the patchwork of regulations, right? Maybe. Julia, how do you manage the trade off, right, between speed to market while ensuring full localized, you know, compliance

Julia Yuan  18:14  
for your clients. For Mike, I think there's a good initiative has been going on. For example, the ACM has been introduced, the common submission doc template. And also, you know, there is also in Australia, there is a mutual recognition agreement, and there is a co our comparable, comparable, oversee regulators, this program and any initiative going on. So I think we can maximize in using these good policies. Initiative has been launched by the government and to ensure the compliance. And also you can speak up and celebrate your Tanana for Tanana as well. So yes, that's the something that we can recommend. And then to maximizing using the policies has been launched by the governments, yeah,

Gabriel Sim  19:03  
yeah. So now we'll move to a little bit more to explore the pathway, right? I mean, you talk about, we talk about localization, right now. Are you seeing more, you know, localization or harmonization approaches in your practice? Yeah. And that's one question. And the other question is, right? You know, what's your strategy for your respective organization to navigate this fragmented landscape?

Carlos Granada  19:30  
Look, in our case is, either we have the knowledge we know how to do it global, we'll still know we need local expertise. I mean, it's impossible to navigate your strategy, if you understand the regional, but also the local, but also the domestic, pathway, is difficult, and Julia just mentioned language barriers, cultural awareness. I mean, you cannot negotiate with a regulatory if you understand how they deal with that, how they communicate. So my, my, always, my plan is okay. We have the strategy. We're going to be but we can, know, say, this is the regional strategy for Asian. No, this is the plan. But then we need to go country by country. Let's say, like these two countries, less how the the process was managed, and then we can escalate to the next level. That's how, basically, we think always,

Julia Yuan  20:21  
yeah, yeah. So I think it's really depends on the company type. For example, the start up company, definitely you need to come up with a different solutions, comparing to the MNC companies. So for the for definitely, just like, you know, you say, the manpower, the local, know, how expertise, I think you cannot get away with local how, for example, the language difference talent. I can't understand any words, and then I cannot speak Taiwanese. Yeah, I saw so I think the manpower and the local, the local law, how, expertise, and you seeking the, for example, the startup company, normally you don't have team, and then the the government require local sponsor to be the local representative to holding the license for those for the device. And that pass, you definitely need to find a partner. But versus, you know, the MNC, they don't need that such service. They have on their own team. They just only need you local knowledge, local expertise to do the work. Then their own company, they do have their outcome to hold the license. So that, I think the different company type of the company level of the stage of company has a different strategy to put it

Gabriel Sim  21:31  
on, okay, I think what we have this challenges, right, regulatory, you know, fragmentation. I think there are also efforts to try to, you know, harmonize, you know, these guidelines and regulations in the region. For example, you know the Asian harmonization Working Party. And I'm sure there are other, you know, initiative that are looking at harmonizing the regulations across the region. So what is your take on some of this initiative. Are they, you know, effective? You know, what is the status? And you know, what can we expect from this? You know, harmonization initiative coming out from the various bodies and agencies.

Julia Yuan  22:15  
I think the best the group has been found, is the initiation, the harmonization, I think is I m d, I F, m, d, if International Medical Device regulatory forum, I think they found a lot of workshop and together all different western country agencies, for example, Europe and European and also Australia is also in The member. And also Japan, China and Singapore is also in and they put a lot of the initiative to harmonize, to harmonize the requirements. For example, they come up with so many guidance, and then most of the country, the agency reviewers is reference to that guidance to become the customized local needs require expectations. So that's the initiative has been put on and going out. And then there's so many focus for example, there is a single medical audit program has been put down. So that part has also increased a lot of efficiency. Once you do the member, the audit has been performed by the one of the member countries saying you don't need to redo the audit again. For example, you do in us already. Australia doesn't, well, recognize that audit result rather than redo another audit outside audit in Australia. So I think that's a lot of initial initiation and then. But the challenging piece is how to balance the countries, rotating, country, local requirements, and just once again, the data sharing is not quite open transparency yet. So that's also come on, but that's quite effective, effectiveness, and I think it's been quite well recognized most of the countries on the world, yeah,

Carlos Granada  23:58  
yeah, no, and I can complement that is, is about countries are aware about international lessons learned. You know, the European case, the ISO standards. You know, for me, I see it is, what is the priority of each country? Are they going to really put the efforts to do this harmonization? Or they said, I need to really be careful about AI. I need to be careful about data sharing. I'm not going to harmonize that. You know, those are basically how the country is going to behave, is going to accept those so, so that's, that's one case. You know, in the other hand, I see maybe more collaborative work on the clinical trial side. You know, when you see the regulation about submissions, for example, I mean, there's a document called the investigator brochure. I see there, there's minor differences, right? But also is the testing is, do you need GLP data? You don't need GLP data. You know, those type of situation. But by accountability you need, you know, a contract. But at the. Then, is a 13, 485, template, right? That's, that's a type of harmonization. So, so I think, you know, it's more about the country priorities, and if they are willing to do it, and if they're open to do it, but it's still, I see a lot of challenges, especially with the AI coming more and more and more in that sense.

Gabriel Sim  25:18  
Yep. So I understand that there are some, you know, regulatory reliance, you know, between, say, you know, Singapore and Singapore, HSA and Thai, FDA. Can, can you let us in on maybe some of the other, you know, regulatory Reliance initiative that are coming out from the region, besides maybe the Singapore HSA and the Thai FDA, you know, Thai FDA using Singapore HSA, HSA as a reference, reference site.

Julia Yuan  25:52  
I think there is a lot of countries doing these practice right now. For example, Australia and has, you know, just like I mentioned, there is a mutual recognition agreement. There is a CO are going on. They can recognize, for example, Singapore HSA approval. And then, to shorten, got a fast track, and then certain of the conformity assessment will be, you know, depends on the Singaporean approval, rather than to reassess by the Australian the other TTA. So there is Australia, they are doing this. And also, for example, Taiwan is recognize, you know, the FDA appearance and CE marking the European appearance, so you can get advertise approval timeline, rather than go traditional approval timeline. And also in in in China right now, they try to introduce the oversee clinical trial data as well. So they accepting, they maximize into accepting, to avoid the manufacturer to redo the clinical trials. But their prioritizations the requirements you have to meet the expectation on the protocol design. So from designing the stage, you probably need to consider a different author, authority, bodies, the agency, bodies, requirements. So there's a lot of initiative. And also the Japan there is a harmonize. They harmonize by doing Japan versus including into the US trials. And then you can accelerate your approval time as well. So there is a quite a lot of initiative, right, and then establishing going on in the Asian hack.

Gabriel Sim  27:26  
Yeah, yeah. So when you mentioned fast track, I just want to get a sense of how, how fast is fast?

Julia Yuan  27:34  
Probably show safe 1/3 of time. Okay, okay, so there's a lot of those. Those here, for example, conformity the CA conformity assessment. A lot of the the, for example, you already done the QMS audit by the single by the single audit program, country members, and then those things you don't have to redo, and then they just simply accept the result outcomes. So that's saving a lot of time. Yes,

Carlos Granada  28:04  
something that I will compliment, you know, initiatives that I started seeing, you know, for example, in Australia, about the tax incentives on R and D, that's something really helpful, and I see it is because aligned with the FDA strategy. FDA, you know, I wouldn't say FDA itself, you know, the US, you know they see is we are losing innovation. Companies are going outside the US to do the first in humans to get approvals, and they shift and they open the door saying we're going to have an early feasibility program and we're going to have a modular PMA program. So basically they're saying, companies come and we help you to navigate these, these approaches. So I see Australia is doing that a lot with companies investing first on the development, first in human and it's a tier one country. These companies are looking as well to go to the US. But also Singapore is some examples. I mean Chinese really strong in that sense. But also is, again, is, is data privacy? Is, who is my data is going to be transfer or is going to be managed? I see, I see a big challenge there.

Gabriel Sim  29:10  
Okay, yeah, okay, so maybe we'll talk about patchwork in a pathway. So maybe let's look into the future. So do you foresee a future, right, where, you know, APEC move towards a harmonized, you know, regulatory framework, or do you think it will still remain, you know, status quo for now, still very much, no Patchwork, in a sense, you know, at least in the near term,

Julia Yuan  29:41  
I think different I think different things. For example, the standard wise will be harmonized. I think eventually, and then clinical trial data will maximize to harmonize, and then to having the global Asia peck the clinical trial, rather than individual so. Then a long country trials. But for, for the Data Wise, for the AI powered medical device, or, you know, there is a involving the data correction, involving the AI powered device, I think that will be localized. Yeah, I think that's something in the future. I don't think there is a trend to having the more transparency, data share, sharing among all over the world. I think that pies, the I think, is more localized, rather than to open for the war, yeah, yeah. So that's really depends on different aspects.

Carlos Granada  30:32  
Yeah, I would agree with that. I mean, even, even in countries, specific countries, even the US, California, has their own act, right? Yeah. So I would by saying, you know, that's gonna be the plan. I mean, I see a really strong normalizations programs now, again, is the willingness of the countries to do it, and data privacy will be a big topic.

Gabriel Sim  30:53  
Yeah, so comments, I just want to pick up that bit that Julia mentioned about AI, right? Some of these emerging technologies like, you know, AI and blockchain, you know, how do you see this? You know, you know, maybe excavating or elevating regulatory fragmentation in a region.

Carlos Granada  31:12  
Look, I see a lot of initiatives, and especially on, for example, translations, review, I see a lot of examples on on narratives, on safety reporting using AI. The big challenge always is how this data is going to be protected, and it's been local, but then again, you need to transfer these to overseas, how they're going to be managed blockchains I have seen, I have been using, I have been part of couple of examples, and in clinical trials in pharmaceuticals is really, you know, they're good examples on Meg Tech, I see challenges, especially because clinical sites are not going to open their EMRs. And, you know, to negotiate that with that is going to be a big liability for these sites, especially phi management at the end, we go until the same bucket is how the data is going to be managed, how the privacy is going to be managed, who is going to be seeing, who's going to be reviewing, who's going to be accepting. But we are going in that direction. I mean, I remember 20 years ago, people talking about capturing data electronically, no paper. Paper Paper was paper, and now look at this. So it's gonna be the time it's gonna take time, but we're going to that direction,

Gabriel Sim  32:28  
yeah, so maybe at this point I just want to open, you know, this session to the floor. If you have any questions, you know, you may want to ask our panelists. I think this is a good opportunity to get the advice and guidance. Yeah, around, you know, yes, some of the things that around regular, regulatory, fragmentation and harmonization, any, any questions from the floor?

Carlos Granada  32:54  
So maybe a question they have for this, who is now thinking, you know, to entry the one of the Asian markets in one of the countries? What do you guys swing, you know, conversations, where the products, you know, because maybe we can start the conversation like that. And is anyone thinking, you know, to access one of these countries, and which product, I'm sorry, your name, it's

Audience Question  33:18  
an orthopedic device from production. But our biggest question balancing market size, geographic centralization and flexibility of first regulatory entry, it's a multi dimensional it is it is

Carlos Granada  33:34  
it? Is it is, yeah, and always, in that sense, is what is going to be the strategy is, is because you need the data just to go back to the US for a future reimbursement strategy, or you want to expand, because you are established in the US. You know, always come to that. But I see your point. I mean, is language?

Julia Yuan  33:55  
Yeah, yeah, exactly, many of local language rather than English. But look,

Carlos Granada  34:05  
we we saw that in Europe. It was the same challenge, you know. And now look how Europe is managing today. These days, of course, the MDR, you know, shift a little things, and didn't help but, but, you know, at the end, okay, exactly. And now you change your strategy, which, but now you said, Okay, how I'm gonna manage what is gonna be my first country? You know, how it's gonna be manage my talent? Yeah, I see that. That that per, yeah,

Audience Question 2  34:40  
just a quick question. To mention Europe. There are a couple of countries like Switzerland and potentially UK now recognizing that if you have FDA accused or approval, if you have already FDA clearance or approval, a couple of countries, starting with Switzerland, have announced that they would recognize that. Exactly, you know, instead, instead of going through the full regulatory review process, do you see that similar approach being taken by any of the Asian countries, or is that part of the discussion that is going on? We have seen

Carlos Granada  35:14  
it. And Julia, I think you Australia is open

Julia Yuan  35:17  
for Singapore as well. Yeah. And Japan,

Audience Question 2  35:20  
yeah, you know, so for Hong Kong, yeah, I would. So at least my understanding. And VR in Australia and US based company, we have clearance and approval sit in both markets. You know, our understanding is, when you still go through the process, it still takes substantial amount of time, although the burden of review goes down. The process is still long. And I was just curious, if you know there are faster pathways that are in play.

Carlos Granada  35:50  
I mean, the process is still going to be there. Still you need to submit year this year, still, you need to support your clinical data, pre clinical, bio test, everything, but the path is going to be faster because you already present it to regulatory authorities like FDA or even the CE mark. Then for them, you said, Okay, now the risk of review is going to be less, but still, you need to follow the process, and it's going to be faster approved for a device that doesn't have any other approval. But yes, it helps a lot,

Julia Yuan  36:23  
but I think it's still different. If you don't have the full fund, for example, Australia, probably you spend more time on the review, on the process, so still saving some time. But like just I mentioned before, right now, the Asian countries introduced a common submission dossier template. So if you prepare under those templates, I think that will save you dramatically the ton as well. So that means they don't need to, you know, you don't need to repeat duplicate to prepare all individual dossiers,

Audience Question 2  36:56  
absolutely. And if I may, ask a follow up question, and if I missed that in the early part of your panel, I apologize. But what's your perspective on using something like MD south as a strategy to accelerate the appro approval process in Asian Asian markets?

Carlos Granada  37:14  
That's an interesting question. I will need to get back to you that, because that's an interesting question, is, how you're going to manage and again, which countries, if you're specific, in one country or multi countries, because, again, you know, it's going to be a local requirements. But that's a good point, you know, to be honest, good point, you know, I'm just thinking now is about that is FDA recently open a path that if you submit through the new portal, you get us Canada in the same submission. So going to that point, that would be a huge benefit here to the Asian countries, and that's going to be countries, you know, difference, but that's a good point.

Gabriel Sim  38:01  
Can you have a show of hands as to how many of us here in this room are product owners or running a company with a product? Yeah? Okay, so maybe one, you know, final takeaway for some of our you know, audience here is that, you know, if they are looking at entering multiple markets in the APAC region, what would be one advice that you would give them?

Carlos Granada  38:25  
Julia, first,

Julia Yuan  38:27  
I think, from the beginning of the designing this product stage, you need to come in mind with a target country, and then to considering all the countries requirements. Where are you designing your product? So that will save a lot of time, and then to avoid the hurdles and the challenges from the different agency, since in China, there's so many agency have to, you have to deal. So I think you know always, you know are playing in other ways, rather than you know to do the modification afterwards. Sometimes you will cause a lot of time, for

Carlos Granada  39:02  
sure, yeah. So maybe I'm thinking here is, of course, if you identify the clinical embed, need you have, okay, the design, product and everything. But always is thinking about is, what is that future that you see in terms of your inflection point? You know how you're going to start, is Asia, because you want to create a differentiation, because the US is so fragmented as well, and there's no a lot of competition, or you want to validate to come back to the US. So that's maybe my recommendation. Just understand what is going to be that strategy and how your investors are thinking as well, and start documenting early, early stage, all these in the development? Because that's going to be a requirement when you start solutions, yep, and your diligence, of

Gabriel Sim  39:47  
course, yep. Okay, yep. Any final questions for our panelists? No, okay with that? No. I just want to thank Carlos and Julia for joining us today. Yeah and Carlos and Julia will be around. Feel free to reach out to them. Thank you. 

Carlos Granada  40:03  
Thank you.