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!
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!