8610

Authorization procedure and Trade Register aspects for CAEN 8610

Establishing a company that will carry out hospital assistance activities (CAEN 8610) requires going through specific stages at the Trade Register (ONRC), different from those for ordinary commercial activities. For legal entities (SA, SRL, SNC, etc.), registration with the trade register is done only after obtaining the prior operating approvals. When submitting the registration application, the main object of activity shall be mentioned as CAEN code 8610, according to the Classification of Activities in the National Economy (CAEN Rev. 3, updated by Government Emergency Ordinance no. 71/2024). For authorized natural persons (PFA, II, IF), the possibility to carry out this activity is limited, as hospital assistance typically involves facilities and specialized staff, specific to a legal entity. When submitting the documents, proof of the registered office must also be attached, which must be a space compliant with sanitary and safety regulations. The processing term at ONRC is 3-5 working days, but may be extended if documents are incomplete. Note that for public hospitals, the registration procedure differs, as they are established by normative acts.

Regulatory framework, specific approvals and control institutions

Carrying out hospitalization activity (CAEN 8610) is strictly regulated by Law no. 95/2006 on healthcare reform, republished, as subsequently amended. For the sanitary operating authorization, the approval of the Ministry of Health or the county public health directorates is required, according to the Methodological Norms approved by the Order of the Minister of Health no. 1500/2008. Additionally, an approval from the Inspectorate for Emergency Situations (ISU) regarding fire safety is required. For day hospitalization or related services, additional approvals may be necessary. The activity is controlled by ANAF (for taxation), the Health Insurance Houses (for reimbursements), and the National Authority for Quality Management in Healthcare (ANMCS), which grants accreditation. Non-compliance with legal conditions attracts contravention sanctions or even suspension of activity.

Tax management, ANAF audit risk and specific accounting

From a fiscal perspective, private hospitals are subject to the provisions of the Fiscal Code (Law no. 227/2015, as subsequently amended). VAT is generally 19%, but certain medical services may be exempt with or without deduction right, according to art. 292 (1) letter c). For hospital services reimbursed by the health insurance house, the exemption regime applies. VAT registration is mandatory if the turnover exceeds the threshold of 300,000 lei. Corporate income tax is calculated quarterly, the standard rate being 16%; there is the possibility of applying the micro-enterprise income tax if the conditions of art. 47-50 are met. The tax vector is submitted to ANAF within 30 days of registration, specifying the CAEN code 8610. The risk of ANAF audit is high due to the specifics of reimbursements with health insurance houses and cash operations. Accounting must distinctly highlight revenues from medical services, personnel expenses, medicines and sanitary materials. The Single Declaration (D212) is submitted annually for income from independent activities, if applicable. The RO e-Factura system is mandatory for all B2B invoices, and e-Transport for the movement of goods with fiscal risk. Clear contracts with suppliers and health insurance houses are recommended, as well as specialized legal advice in medical law.