Oman is an emerging hub for the medical device industry, driven by a growing healthcare sector and government investments. The registration of medical devices in Oman is overseen by the Directorate General for Pharmaceutical Affairs and Drug Control under the Ministry of Health. Manufacturers looking to enter the Omani market must follow a structured regulatory process that includes appointing a local authorized representative, submitting necessary documents (such as CE Certificate, Free Sales Certificate, and QMS Certificate), and complying with device classification rules (Class A–D). The approval process may take up to two years, and licenses are valid for five years. Regulatory consultants like Operon Strategist help simplify the compliance and registration process, ensuring that medical device companies meet all legal and quality requirements to successfully market their products in Oman.