Regulations

Medical device registration is one of the most critical steps in launching a healthcare product globally. Every market has its own set of regulations, documentation requirements, and compliance expectations. For manufacturers, this often means navigating a complex and time-consuming process before a product can legally reach hospitals, clinics, or patients. That’s where OMC Medical Limited comes in. Recognized as one of the best companies for medical device registration, OMC helps manufacturer...

Getting a medical device approved in multiple countries can feel like navigating a maze — every region has its own rules, documentation format, and approval process. But that’s changing fast. By 2026, global regulatory harmonization is expected to simplify how medical devices reach markets around the world.  At OMC Medical, we help manufacturers get ahead of these changes. Whether you’re entering Canada, the UK, the Middle East, or Asia, understanding and preparing for harmonization now...

Senegal represents a pivotal pharmaceutical market in West Africa. For pharmaceutical companies looking to introduce their medicines, understanding and complying with the regulations set by the National Agency for Health Safety (ANSSA) is the first and most critical step. OMC Medical, with its deep expertise in Pharma Registration Senegal, provides this strategic overview to help you prepare.  The Governing Body: ANSSA  ANSSA is the central regulatory authority responsible for ensuring the...

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 step...

Expanding your medical device business into Ghana requires a clear understanding of the country’s regulatory framework governed by the Ghana Food and Drugs Authority (FDA). Navigating this process can be complex — from product classification to dossier preparation, inspections, and approvals.  That’s where OMC Medical comes in. As a trusted global regulatory consultancy, OMC Medical supports manufacturers and importers in obtaining Medical Device Marketing Authorizations in Ghan...

Navigating ANSSA: Your Roadmap to Senegal Medical Device Registration The Senegalese healthcare market is rapidly expanding, offering significant opportunities for manufacturers of medical devices. However, gaining market access requires strict adherence to the regulatory framework governed by the National Agency for Health Safety (Agence Nationale de la Sécurité Sanitaire – ANSSA). At OMC Medical, we specialize in guiding companies through the precise requirements for Medical Device Reg...