8622

Authorization procedure and Trade Register aspects for CAEN 8622

Setting up a company that carries out specialized medical assistance activities (CAEN code 8622) involves going through the standard registration steps at the Trade Register (ONRC), noting that the main or secondary object of activity must be rendered exactly according to the Classification of Activities in the National Economy – CAEN Rev. 3. When submitting the registration application, the affidavit provided by Law 359/2004 shall be completed, whereby the administrator/associate declares that the company meets the specific operating conditions for the medical field. Although ONRC does not require medical approvals at the time of establishment, it is mandatory to subsequently obtain the sanitary operating authorization issued by the territorial Public Health Directorate (DSP), as well as the approval from local authorities (e.g., for compliance with fire safety regulations, according to ISU). For legal entities that only manage the practices without actually providing medical care, the qualification of physician is not required, but the employed medical staff must hold membership certificates from the College of Physicians. The constitutive act shall be filed with ONRC, and for LLCs, the minimum share capital is RON 200, with no special capital conditions for this CAEN code.

Regulatory framework, specific approvals and control institutions

CAEN code 8622 falls under Law 95/2006 on healthcare reform, Ministry of Health Order 381/2016 approving the sanitary authorization rules, and related legislation on data protection (GDPR, given the processing of medical data). Activities are carried out only based on the DSP authorization, which is requested after registration with ONRC. Sanitary control is ensured by DSP, professional control by the College of Physicians for doctors and by the Order of Medical Assistants for nursing staff. ANAF (Tax Authority) checks compliance with tax obligations, while the Labor Inspectorate controls labor relations. A critical aspect is the obligation to maintain the unique patient registry and to archive medical documentation according to regulations. Also, malpractice insurance for physicians is required, and the company must have contracts with health insurance houses if it operates in the social health insurance system. Any change in the associative structure or registered office shall be notified to ONRC and subsequently to DSP.

Tax management, ANAF audit risk and specific accounting

From a fiscal perspective, companies with CAEN 8622 are obliged to register as VAT payers if turnover exceeds the threshold of RON 300,000; below this threshold they may opt for exemption. Profit tax applies at the standard rate (16%) or, if they are micro-enterprises (turnover up to RON 1,000,000), they may apply the micro-enterprise income tax (1% on income). We recommend analyzing the fiscal vector at establishment, since medical services may be VAT-exempt for services directly to patients (according to Article 292 of the Fiscal Code). Companies billing to insurance houses must issue invoices according to the RO e-Factura system, and statements are submitted monthly. ANAF may initiate a tax audit based on risk criteria: declaring low income compared to the number of patients, lack of qualified medical staff declared in REVISAL, or failure to register employment contracts. Specific accounting involves separate recording of income from medical services, expenses with sanitary materials and medicines, depreciation of equipment (practice, apparatus), plus personnel expenses (doctors, assistants). We recommend keeping supporting documents for each consultation (medical file, contract, fiscal receipt) for at least 10 years, according to medical archiving rules. The major fiscal risk consists of non-declaration of income from services in the private system or improper deduction of medicine expenses, which may be considered benefits in kind. Companies with CAEN 8622 benefit from limited tax facilities (VAT exemption for medical services, but not for related materials) and must file the single declaration for the own income of associate physicians, if they carry out independent activities within the company.