US FDA 510k Clearance Complete!!!! Africa???

Mangafanga

Starting to get Involved
Hello,

We have received 510k clearance by US FDA. We would like to take this device to African countries and help the population for a negligible cost. I have the following questions:
> Is there any additional regulatory requirements for African countries even after US FDA 510k clearance? or is it may be only additional thing could be a registration?
> Is an ISO 13485 certificate necessary?
> Is there a requirement to have an agent like US FDA and Authorised Rep like EU for a foreign company?

Note: We plan to import these devices to the African countries from China, and don't plan to manufacture in Africa itself.
 

DallasThomasIQVIA

IQVIA Medical Device-Pharmaceutical FDA Consultant
Hello, as far as I know there is no fast track to African countries that will grant a medical device approval based on having an FDA 510(k) only. Some foreign countries require a home-country approval in order to sell abroad. This can be achieved by requesting an apostilled CFG (Certificate to Foreign Government), however they will all most likely have additional applicable regulatory requirements in my experience.. Yes most countries outside the US recognize the ISO 13485 Certificate as compliance for the Quality Management Systems. The majority of countries do require a Marketing Authorization Holder (MAH) with in-country ties. However there are a number of countries that do not have that requirement. Also related to recognition of the CE Mark. If you have a CE Mark, more countries will recognize that internationally yet may have some additional regulatory requirements beyond the CE Mark Approved Certificate issued by a notified body. Hope that helps.
 

Parul Chansoria

Regulatory and Quality Expert
Hi @Mangafanga, first of all congratulations on receiving a 510k clearance by the USFDA. A big milestone achieved!

To answer your question -

There is no unified regulatory authority for medical devices across the entire continent of Africa. Some regulatory bodies for different countries within Africa are as follows:
  1. South Africa:
    • The South African Health Products Regulatory Authority (SAHPRA).
  2. Nigeria:
    • The National Agency for Food and Drug Administration and Control (NAFDAC).
  3. Kenya:
    • The Pharmacy and Poisons Board (PPB).
Each country's regulatory authority has its own set of requirements and processes for the approval or clearance of medical devices. I would recommend the following steps:

  1. First, come up with a list of countries that you want to target based on the medical need.
  2. Identify the regulatory bodies in each of the countries that you have narrowed down.
  3. Ensure you know the regulatory requirements of the regulatory bodies with whom you have to work to get approvals. Like SAHPRA recognizes ISO 13485 certification as an important quality management system standard for medical devices, but also have additional requirements of their own on the regulatory side.
  4. Prepare applications for the regulatory agencies and identify and appoint a local representative. For this step, you can certainly leverage most testing and documentation that you did for the FDA, for leveraging these, a gap assessment will serve as a great start.
In some countries a mere registration will work, while for others an application and approval will be needed. This will depend on the classification and regulatory framework of the countries you are targeting. The 4 step systematic approach suggested above will come handy and allow you to get to these markets quickly while providing stakeholders realistic timelines and expectations.

Hope this helps.
All the best,
Parul Chansoria
 

Mangafanga

Starting to get Involved
Hi @Mangafanga, first of all congratulations on receiving a 510k clearance by the USFDA. A big milestone achieved!

To answer your question -

There is no unified regulatory authority for medical devices across the entire continent of Africa. Some regulatory bodies for different countries within Africa are as follows:
  1. South Africa:
    • The South African Health Products Regulatory Authority (SAHPRA).
  2. Nigeria:
    • The National Agency for Food and Drug Administration and Control (NAFDAC).
  3. Kenya:
    • The Pharmacy and Poisons Board (PPB).
Each country's regulatory authority has its own set of requirements and processes for the approval or clearance of medical devices. I would recommend the following steps:

  1. First, come up with a list of countries that you want to target based on the medical need.
  2. Identify the regulatory bodies in each of the countries that you have narrowed down.
  3. Ensure you know the regulatory requirements of the regulatory bodies with whom you have to work to get approvals. Like SAHPRA recognizes ISO 13485 certification as an important quality management system standard for medical devices, but also have additional requirements of their own on the regulatory side.
  4. Prepare applications for the regulatory agencies and identify and appoint a local representative. For this step, you can certainly leverage most testing and documentation that you did for the FDA, for leveraging these, a gap assessment will serve as a great start.
In some countries a mere registration will work, while for others an application and approval will be needed. This will depend on the classification and regulatory framework of the countries you are targeting. The 4 step systematic approach suggested above will come handy and allow you to get to these markets quickly while providing stakeholders realistic timelines and expectations.

Hope this helps.
All the best,
Parul Chansoria
Please don't write Chat GPT answers atleast in my thread. By reading your answers it looks like you are new to the RA field and trying to understand Regulations by reading Blogs and articles with no real work experience.
 

kjlcm

Registered
Please don't write Chat GPT answers atleast in my thread. By reading your answers it looks like you are new to the RA field and trying to understand Regulations by reading Blogs and articles with no real work experience.
Hi Mangafanga,

I never post here but was startled by your response. I have to say that you are wrong here. I have been in the industry for 25+ years and this response from Parul Chansoria is correct. Even if ChatGPT was used to answer (I have no idea), this is what we would do to enter new countries. The only difference I would suggest is that for step 4 every country may not need a local representative, it is up to their regulations.

Regards
 
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