Medical devices regulatory consultancy services by Ethiobiomedical
Ethiobiomedical provides a range of medical devices regulatory consultancy services to medical device companies including manufacturers and distributors. These consultancy supports include- ISO 13485-2016 and additional Quality management system related regulatory requirements, medical devices registration documents compilation support (based on Submission Table of Contents by International Medical Devices Regulators Forum (IMDRF) and jurisdiction specific marketing authorization requirements, devices registration process handling on behalf of manufacturers or product owners, post-market surveillance and vigilance investigation supports, etc. Please click on the following links to get details of the regulatory supports you need.
Medical device and IVDs Regulatory Registration Consultancy
ISO 13485-2016 Compliance support for Certification and Regulatory Audit
Development of documents templates for manufacturers to adapt and use for regulatory compliance
- ISO 13485 mandatory documents templates
- ISO 14971 documents templates (including Risk management procedures, Risk management plan, and hazard traceability matrix)
- Templates for some selected technical studies needed to support the registration submissions.
Pan-African Regulated Products Intelligence Database
Ethiobiomedical hosts the largest publicly searchable database of regulated pharmaceutical and medical device registrations across Africa. The database covers 200,000+ registered products and 100,000+ registrations from 12 African National Regulatory Authorities (NRAs)- including Nigeria NAFDAC, Kenya PPB, South Africa SAHPRA, Ghana FDA, Tanzania TMDA, Egypt EDA, Ethiopia EFDA, Rwanda FDA, Zambia ZAMRA, Uganda NDA, Zimbabwe MCAZ, and Côte d'Ivoire AIRP. Whether you are planning African market entry, conducting competitive intelligence, or verifying registration status of a product, the database gives you instant, searchable access to official NRA registration data in one place.
- Search by country, product name, manufacturer, certificate number, category, or registration status
- Filter across 5 product categories: Medicines, Medical Devices, Food, Cosmetics, and Veterinary Medicines
- Free account available — Pro and Premium plans from $29/month for unlimited searches, CSV export and AI integrated market analysis from real data.
Search the Africa NRA Database — 200,000+ Products from 12 African NRAs →
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