Medical Device Registration in various African countries

S

schneck_2005

#1
#1
Hi everyone,

I have to make some registrations for a customer in Africa and I'm not able to find registration requirements for the most countries. Has anyone experience in:
Angola, Zambia, Mozambique, Zimbabwe, Namibia, Botswana, Madagascar, Kenya, Uganda, Tanzania or Ethiopia?
Are there even regulations or can I just sell the products without registration?

Thank you so much!
 
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K

kbryde

#2
#2
Hi there,

I am doing the same thing at the moment for at least some of the countries on your list, and have some information on a couple of them :)

In Kenya, there are no regulations, but a draft is available and the authorities are actually requesting industry to comment.

In Zimbabwe, only drugs are regulated and as far as I can tell, condoms and gloves as the only medical devices.

In Uganda, drugs are regulated but not medical devices.

In Tanzania, medical devices are regulated under the TFDA Act which is from 2012.

If you go to the African Medicines Regulatory Harmonization (AMRH) website, you can find links to the above mentioned countries Regulatory Agencies as well as a lot of different information about the area.

I myself would be very interested to hear on the remaining countries as well as any additional information than what I have been able to dig up :)

Good luck!

/kbryde
 
S

schneck_2005

#3
#3
Hi kbryde,

thanks for the Information.

I only found regulations for Tanzania (tfda.or.tz) and Ethiopia (fmhaca.gov.et). Some of the other countries have regulations for drugs but medical devices are not mentioned.
I think the only way to find it out is asking the MOHs directly or finding a distributor/consultant that has experience.

I'll keep you updated ;)
 
N

nurhakim

#4
#4
Hi Cove,

For Ethiopia, you can refer to FMHACA website, there are several forms & documents to fulfill for application:
1. Application form
2. Consent form
3. Certificates hold by your organization
4. Details of your manufacturing/production unit
5. Details of your QC unit
6. Technical info of product
7. Labeling of packaging
8. Product registration and marketing experience
9. Agreement between manufacturer/distributor
10. Authorization letter
11. Certificate of free sales
 
N

nurhakim

#5
#5
Hi Cove,

For Tanzania please check TFDA website. Documents needed are:
1.Application form (Annex I from TFDA website)
2.Authorization letter to authorize agent in Tanzania
3.Quality system certificates
4.Brochures/catalogue
5.Instructions for use-if applicable
6.Declaration of Conformity
7.Product samples
 
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