Medical device registration in African/Asian countries

#1
I have to find regulatory requirements of a number of African and Asian countries; but no online information is available and their MoH did not respond any of my mails. Do these countries have official regulations (like MDD) for medical devices?

Countries such as:

Benine
Burkina Faso
Cape Verde
Chad
Central African Rep.
Comoros
Guinea Bissau
Madagascar
Mali
Mauritania
Réunion
Saint Helena
Sao Tome and Principie
Senegal
Seychelles
Somalia
Togo
Western Sahara

Do you have any experiences for countries like this?
Please help me :eek:
 
Last edited:
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GStough

Staff member
Super Moderator
#2
ARQon|Singapore|Medical Device Consulting|Regulatory|Medtech

Here is something I found in a quick search for "medical device regulations Africa Asia". I'm not familiar with the regulations/requirements for Asia and Africa. Perhaps you can scroll through this link and find more information that is relevant to your needs.

Hope this helps. :bigwave:


I have to find regulatory requirements of a number of African and Asian countries; but no online information is available and their MoH did not respond any of my mails. Do these countries have official regulations (like MDD) for medical devices?

Countries such as:

Benine
Burkina Faso
Cape Verde
Chad
Central African Rep.
Comoros
Guinea Bissau
Madagascar
Mali
Mauritania
Réunion
Saint Helena
Sao Tome and Principie
Senegal
Seychelles
Somalia
Togo
Western Sahara

Do you have any experiences for countries like this?
Please help me :eek:
 

Ronen E

Problem Solver
Staff member
Moderator
#3
I have to find regulatory requirements of a number of African and Asian countries; but no online information is available and their MoH did not respond any of my mails. Do these countries have official regulations (like MDD) for medical devices?

Countries such as:

Benine
Burkina Faso
Cape Verde
Chad
Central African Rep.
Comoros
Guinea Bissau
Madagascar
Mali
Mauritania
Réunion
Saint Helena
Sao Tome and Principie
Senegal
Seychelles
Somalia
Togo
Western Sahara

Do you have any experiences for countries like this?
Please help me :eek:
Hello lyannastark and welcome to the Cove :bigwave:

None of the countries on this list are in Asia. They are all in or off the coasts of Africa. Some Asian countries have elaborate medical devices regulatory systems, including a lot of good info available online, but I don't know if that's actually relevant to you.

With regards to the countries you listed, I know nothing about their regulatory requirements, and honestly, I think most of them don't have any such system in place (for example all those little island nations or hunger/war struck countries). I presume that you ask because you intend to sell devices in those countries - right? So you must have some local contacts (importers/distributors). I would try to utilise such contacts to find out what the local requirements might be, considering that there might also be a language barrier for you (not to mention cultural barriers).

Good luck!
Ronen.
 

Mallappa

Involved In Discussions
#4
Hello everyone :bigwave:

Need your help to understand medical device regulation in African countries?

1. Is there any collaboration between national medicines regulatory authorities available in African countries apart from ZAZIBONA?

2. If you can indicate if a regulatory affairs environment is establish and enforced that is not related to the one in South Africa (SAHPRA, formerly MCC) for the applicable countries: Angola, Botswana, Democratic republic of Congo, Ethiopia, Kenya, Malawi, Mauritius, Mozambique, Namibia, Tanzania, Uganda, Zambia, Zimbabwe?

3. What are all the African countries that follow South African medial device regulations (SAHPRA)?

Thanks in advance,
Mallappa
 

Marcelo

Inactive Registered Visitor
#5
I can't help right now but I'm doing work for a client to identify regulatory requirements of some African countries. When I get something I may put the info here.
 
#7
Unknown: Angola, Democratic republic of Congo, Malawi, Mauritius, Mozambique, Namibia

Have Regulator: Botswana, Ethiopia, Kenya, Tanzania, Uganda, Zambia, Zimbabwe

The processes are highly variable from what I've experienced with Ethiopia, Kenya, Tanzania and Zimbabwe being the most stringent among the names you mentioned.

@Marcelo - happy to share information with you on this if it would be of any help.
 

Mallappa

Involved In Discussions
#8
Hi Supadrai,

Thanks a lot for the valuable information.

as per the search, Botswana do not have medical device regulations when compared to Ethiopia; Kenya; Tanzania; Uganda; Zambia; and Zimbabwe: only condoms & gloves are regulated.

Thanks again!
 
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