General questions about marketing to developing countries

stm08007

Registered
We have been marketing our devices in the US for many years, however are looking into requirements of other countries to potentially go into. Canada is very clear with regard to what they need, however other countries like Carribbean nations and African nations have very limited information I can find about them. What is the general best practices people do prior to selling in there? We also have pro bono devices that we ship (not sell) and devices that we distribute on behalf of another (our name doesn't appear on the label). For the countries with more stringent regulatory requirements (i.e. US and Canada), I understand these devices would be subject to their regulations, however I assume this may not be the case with some of the developing nations.

Any guidance is much appreciated. I see there are many unanswered questions on this forum about specific developing countries, so there must be some general best practices out there to determine if and when you can ship to these nations? Surely smaller medical device companies may not have the regulatory resources to look into this if it is not easily available online. And if it's not available online, does that mean there is no enforcement in those countries and people just ship to them without further issue? When I had worked for a different company that already shipped worldwide, I remember they had very specific procedures for a handful of nations (MDSAP jurisdictions, plus I believe a couple other Asian countries), however there was not specific procedures for every country in the world which makes me believe some countries simply did not have rules. Also--- even if there is no regulation currently, in 10 years there might be, so I assume there should be some means in place to periodically review whether any new requirements have arose in these developing nations.

Thanks!
 

SeanN

Involved In Discussions
This is about International Business 101. In the most basic entry mode, you should have your local business partner e.g. importer/distributor... Check with them first. They should know something to start selling MDs. I am not aware of any countries without Ministry of Health or eq.
 

stm08007

Registered
This is about International Business 101. In the most basic entry mode, you should have your local business partner e.g. importer/distributor... Check with them first. They should know something to start selling MDs. I am not aware of any countries without Ministry of Health or eq.
I don't think it's quite as basic as you are saying-- look at other recent posts on this "Other Medical Device Regulations Worldwide" subforum; there's questions for Georgia, India, Iraq, Egypt, etc that have been asked months ago with no answers. Looking quickly for the countries I am wondering about, I see very limited information online.

Also per these links:
ncbi.nlm.nih. gov/pmc/articles/PMC8087432/
facesofdigitalhealth. com/blog/medical-device-regulation-mdr-africa
(remove the space before gov and com)

there is the implication that there is a general lack of regulation in Africa. A small company may not have a "local business partner" in each of the countries in question that is well versed in their particular medical device legislation (this is because there seems to be a general lack of organized information online). Even if the "partner" does claim to know what the rules are, how can you confirm this if that information is not readily verifiable online. I agree with you that a level of due diligence has to be done before shipping to these countries, I am just trying to figure out the best way to do said due diligence.

So I still am wondering how most companies get this figured out; certainly there are smaller companies who figure out a way to ship to some of these developing countries?
 

zkinney

Starting to get Involved
For Africa, the following link/url may be useful. Click on the countries you are interested in selling/donating in. A M R H (dot) N E P A D (dot) O R G (slash)

It is far from perfect or exhaustive, but will link you to the regulatory bodies of many countries. They often have their laws/regulations linked to those websites.

You are correct, some countries have zero information available online. I do not have a solution for that without a reliable local partner.
 

SeanN

Involved In Discussions
If there is an absolute lack of regulations, you can sell MDs as potatoes or cookies.
It it's about poorly-defined regulatory process, the best way is to get local expertise to navigate thru all obstacles.
If you don't trust your local partner and still want to do business, then the only way is to have someone you trust on site. I don't know about Georgia, Iraq, or Egypt but India has pretty well-defined regulatory processes wrt MDs.
If you want to sell something, the buyer (importer, distributor) is your local partner. If you just want to understand RA environments without any business, you can do web search as above. But trust me, the real world can be very different. I worked with developing markets for decades and found hands-on experience indispensable.
 

stm08007

Registered
If there is an absolute lack of regulations, you can sell MDs as potatoes or cookies.
It it's about poorly-defined regulatory process, the best way is to get local expertise to navigate thru all obstacles.
If you don't trust your local partner and still want to do business, then the only way is to have someone you trust on site. I don't know about Georgia, Iraq, or Egypt but India has pretty well-defined regulatory processes wrt MDs.
If you want to sell something, the buyer (importer, distributor) is your local partner. If you just want to understand RA environments without any business, you can do web search as above. But trust me, the real world can be very different. I worked with developing markets for decades and found hands-on experience indispensable.
All good points... I'm envisioning a situation where a small company might ship directly to their end customer as some do domestically in America. Is this not a possibility overseas? What if they only ship a handful of orders per year to say Iraq, etc. presumably it might not be cost effective to work with a local distributor? (Maybe it is, I am not sure how those things work)

Or are you saying basically by default if you're shipping into another country it would not be going directly to end user?
 

SeanN

Involved In Discussions
Some types of MDs can be sold on "markets" such as Amazon, Alibaba...
If you ship commercial goods into another country, you should better have a local partner. Otherwise, the business would be insignificant and risky. (Buyers receive your products as personal gifts, high shipping cost and may be taxed, sometimes held at the customs / returned at your cost etc.).
 
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