Regulations
Taking your healthcare technology to the market is a great way to grow your business. The African market is a place for healthcare technology to grow. However to sell your devices and things like that in Africa you have to deal with a lot of rules and regulations. The rules are different, in places and it can be hard to understand what to do. You have to navigate through all these rules to sell your devices and IVDs in the African market. From the rigorous audits of SAHPRA to the localized statutory mandates of FDA Ghana , NAFDAC registration and the EDA, manufacturers must secure independent local representation and tailor their technical dossiers for each distinct jurisdiction.
At Morulaa Health Tech, we serve as your unified regulatory partner. We manage your technical files, facilitate mandatory representation, and oversee your product lifecycles. By centralizing your strategy, we help you avoid commercial lock-in with distributors while ensuring rapid, compliant market entry.
We provide localized expertise and technical documentation support tailored to the precise legal frameworks of the major African markets.
South Africa Medical Device Regulation
Compliance with South Africa medical device regulation is strictly enforced by the South African Health Products Regulatory Authority (SAHPRA).
Documentation: Securing approval under the South Africa medical device regulation framework requires a mandatory South African Responsible Person and a current ISO 13485 certificate.
Timelines: Under current South Africa medical device regulation, Class A/B devices take 3–6 months, while high-risk Class C/D devices require 6–18 months.
Fees & Vigilance: South Africa medical device regulation mandates a standardized fee of ~$1,010. Furthermore, South Africa medical device regulation requires reporting serious threats within 15 days.
Nigeria Medical Device Registration
In Nigeria the National Agency for Food and Drug Administration and Control is in charge of Nigeria medical device registration. To get Nigeria medical devices registered quickly you need to know what the National Agency for Food and Drug Administration and Control wants. Nigeria medical device registration can be done fast if you understand the National Agency for Food and Drug Administration and Control registration requirements, for Nigeria devices.
Process: A successful NAFDAC registration requires a local applicant and laboratory analysis. We ensure your NAFDAC registration dossier and Power of Attorney are flawlessly prepared.
Timelines: Nigeria medical device registration typically takes 120 working days. The official cost for a full NAFDAC registration is approximately $1,252, though additional fees may apply.
Representation: To maintain market flexibility, your NAFDAC registration should be held by an independent representative rather than a distributor.
FDA Ghana Registration
Before you start selling things in the market companies from countries need to make sure they follow the rules set by the FDA in Ghana. The Foods and Drugs Authority Ghana is responsible for ensuring that devices are safe for people to use.
The Foods and Drugs Authority in Ghana has a system to regulate things. It is very good. The Foods and Drugs Authority, in Ghana has reached a level of quality this level is called WHO Maturity Level 3. This means that the FDA in Ghana has a good system in place and it is one of the best in the area.
Process: The Foods and Drugs Authority Ghana utilizes technical advisory committees for risk management. We manage your FDA Ghana digital submissions and align clinical data with the advanced expectations of the Foods and Drugs Authority Ghana.
Compliance is very important. Following the rules of the FDA in Ghana means that the things you make are really good and meet the standards of the Foods and Drugs Authority Ghana.
Egypt Medical Device Registration
Egypt medical device registration is overseen by the Egyptian Drug Authority.
Documentation: To complete your medical device registration, in Egypt you need to appoint a Registration Holder.
Timelines: The Egypt medical device registration process takes 6–8 months.
Validity: A significant benefit of Egypt medical device registration is the 10-year license validity.
Kenya Medical Device Registration
Kenya medical device registration requires strict compliance with the Pharmacy and Poisons Board (PPB).
Process: The Kenya medical device registration pathway requires foreign manufacturers to assign a local agent with a Power of Attorney.
Compliance: Before Kenya medical device registration is granted, the Board verifies cGMP compliance. We facilitate the master files required for successful Kenya medical device registration.
Across the African continent, Morulaa Health Tech ensures your submission aligns with core regional prerequisites, including NAFDAC registration and FDA Ghana standards.
Classification: Confirm device class under NAFDAC registration rules or FDA Ghana guidelines.
FSC: Obtain a legalized Free Sale Certificate for your Egypt medical device registration or Kenya medical device registration.
We need to make sure our Quality Management System is in shape for the medical device regulation audits in South Africa. This means our Quality Management System must have the ISO 13485 certificate and the MDSAP certificate.
We need to make sure our Quality Management System is working well for the medical device regulation audits in South Africa. Our Quality Management System needs to have the ISO 13485 certificate and the MDSAP certificate.
We have to get all our documents ready for our Quality Management System so that our Quality Management System's ready for the audits. This is necessary for registration with the FDA Ghana and NAFDAC, for our Quality Management System.
What happens if we change our distributor after NAFDAC registration?
Because NAFDAC registration is tied to a local entity, using a distributor as your applicant gives them leverage. We advise an independent rep to hold your NAFDAC registration.
How does the WHO ML3 status of the FDA Ghana affect our plan?
The FDA Ghana is a Maturity Level 3 agency. This means their review processes are very standardized and follow guidelines.
Can we skip using an agent for FDA Ghana or NAFDAC registration?
No we cannot. Both the FDA Ghana and NAFDAC registration processes require an agent who is registered in the country. This agent acts as a contact.
Can we register our device in Egypt without an Egyptian Registration Holder?
No that's not possible. The Egyptian Drug Authority says that all foreign manufacturers must have a Registration Holder. This holder is the contact for pre-market submissions and post-market monitoring.As your consultant I help you set up this entity. We make sure it is separate from your sales channels to protect your property.
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