Angola’s growing healthcare sector presents a promising frontier for medical device manufacturers. However, market entry is strictly regulated by the National Institute for Health Regulation and Equipment (Instituto Nacional de Regulação e Equipamentos de Saúde – INABEC). Successfully navigating this process is key to unlocking this potential. At OMC Medical, we provide expert guidance to secure your Medical Device Registration Angola.
This article breaks down the essential steps and requirements set by INABEC.
The Regulatory Authority: INABEC
INABEC is the central body responsible for regulating medicines, medical devices, and health equipment in Angola. Its mandate is to guarantee the quality, safety, and efficacy of all health products, making INABEC Medical Device Approval a non-negotiable requirement for market access.
Key Steps for Medical Device Registration in Angola
- Appoint a Local Legal Representative:
Foreign manufacturers must appoint a Local Authorized Representative Angola with a legal presence in the country. This representative acts as the primary point of contact with INABEC and assumes legal responsibility for the product. OMC Medical can serve as your reliable local agent.
- Product Classification:
Medical devices are classified into four classes (I, IIa, IIb, and III) based on risk, aligning with the African Medical Devices Forum (AMDF) guidelines and other international models. Correct classification is paramount as it dictates the regulatory pathway.
- Dossier Compilation (The Technical File):
A comprehensive Technical File Angola must be prepared in Portuguese. This is the core of your application and must include:
- Administrative Documents: Application forms, Power of Attorney for the local representative, and a Free Sale Certificate (FSC) from the country of origin, legalized by the Angolan Consulate.
- Quality System Evidence: A valid ISO 13485 certificate or evidence of a Quality Management System.
- Technical Documentation: Complete device description, labels and Instructions for Use (IFU) in Portuguese, design and manufacturing information, and product specifications.
- Risk Management File: As per ISO 14971.
- Clinical Evidence: Data supporting the safety and performance of the device.
- CE Marking or US FDA Approval: A valid CE Certificate (serving as a Type Examination Certificate) or FDA approval is highly advantageous and can significantly expedite the INABEC review.
- Submission and Technical Assessment:
The complete dossier is submitted to INABEC for a detailed scientific and technical review. The timeline for this assessment varies but can take several months. INABEC may request additional information or clarifications during this stage.
- Grant of Marketing Authorization:
Upon a successful evaluation, INABEC issues the Medical Device License, also known as the INABEC Certification. This authorization allows for the import and commercial distribution of the device in Angola.
- Import License and Post-Market Surveillance:
Following registration, the local representative must obtain a Medical Device Import Authorization Angola from the Ministry of Health. The MAH is also responsible for implementing a post-market surveillance system to monitor the device’s performance and report any adverse incidents to INABEC.
Why Choose OMC Medical for Angola?
The path to INABEC Medical Device Approval is intricate and requires local expertise. OMC Medical offers end-to-end support to ensure your registration is successful and efficient. Our services include:
- Acting as your official Local Authorized Representative Angola.
- Managing the entire Medical Device Registration Angola process.
- Preparing, reviewing, and translating your Technical File to meet INABEC standards.
- Providing liaison and follow-up with INABEC authorities.
- Advising on post-approval compliance and import logistics.
Contact OMC Medical today to streamline your market entry into Angola’s dynamic healthcare sector.
