New Law Proposed to Clarify Medical Equipment Regulations
Skopje, 18/04/2026 – The Ministry of Health has published a draft law concerning medical equipment in the National Register of Regulations (ENER), initiating a public debate surrounding a significant legal development. This initiative is part of a wider reform encompassing revisions to twelve existing laws being implemented by the Ministry. The proposed law aims to establish a dedicated legal framework for medical equipment.
Currently, the field operated under a combined regulation with medicines, but this new legislation seeks to create a more precise and contemporary system. This separation is intended to provide a clearer and more functional approach to regulating medical equipment. The revised law is designed to align more closely with the specific requirements of the sector and facilitate harmonization with relevant standards.
Stakeholders anticipate the new legal solution will contribute to improved oversight and management of medical equipment. The public debate will allow for consideration of the implications and potential adjustments to the draft before its final implementation. The focus remains on establishing a robust and efficient regulatory environment for medical equipment.
Topics: #medical #equipment #law
