8621

Authorization Procedure and Trade Register Aspects for CAEN 8621

Setting up a commercial company that will carry out general medical practice activities (CAEN 8621) requires going through the standard registration stages at the Trade Register (ONRC), but with specific prior authorization requirements. According to Law 31/1990, the constitutive act must be filed with the trade registry office attached to the court in whose territorial jurisdiction the company will have its registered office. The registration application must be accompanied by proof of name availability and proof of registered office (lease agreement, ownership deed, or loan for use). For CAEN 8621, providing medical services requires a sanitary operating authorization issued by the territorial Public Health Directorate (DSP), which must be obtained before starting the activity. Although Law 359/2004 allows the submission of a sworn declaration for certain activities, for CAEN 8621, the DSP endorsement is required. Additionally, if establishing an individual medical practice or a professional company, registration in the Unique Register of Medical Practices (RUCM) managed by the Romanian College of Physicians is also necessary. Lack of these authorizations attracts contraventional sanctions and may lead to the suspension of activity by the Trade Register.

Regulatory Framework, Specific Approvals, and Control Institutions

The main legal framework includes Law 95/2006 on healthcare reform, which establishes the conditions for organizing and operating healthcare units. Depending on the form of organization (individual practice, LLC, medical civil society), the regulations on the practice of the medical profession also apply – Law 163/2004. If the company intends to enter into contracts with health insurance houses (CNAS), it must meet the authorization criteria provided by Order MS/CNAS no. 323/2011. Necessary approvals include: sanitary operating authorization from DSP, registration with CNAS (if contracting is desired), and the endorsement of the College of Physicians for the employed medical staff. Control institutions are: DSP (for hygiene and operating conditions), Tax Authority (ANAF) (for taxation), Labor Inspectorate (ITM) (for labor relations), and CNAS (for reimbursements). Failure to comply with legal conditions regarding sterilization, medical waste management, or equipment fitting attracts substantial fines and may lead to the closure of the unit.

Tax Management, ANAF Audit Risk, and Specific Accounting

From a tax perspective, income from general medical practice activities may be subject to income tax (for sole practitioners) or corporate tax (for LLCs). Most individual medical practices are micro-enterprises under the Fiscal Code, applying income tax of 1% or 3% if they exceed the threshold of EUR 500,000. For medical services provided on a direct payment basis, VAT of 19% applies if the turnover exceeds the threshold of RON 300,000 (approximately EUR 60,000). It is essential to separately record income from services reimbursed by CNAS and those from private services. ANAF has an increased audit risk in the medical field, particularly regarding the correct declaration of cash receipts and compliance with RO e-Factura obligations for all issued invoices. Also, rigorous management of medical supplies and drug inventories (if administered) is required, as well as depreciation of medical equipment. Monthly obligations include filing D112 returns (social contributions) and D300 (VAT return). The risk of income reassessment by inspectors is high if the minimum fee schedule established by the College of Physicians is not respected. The recommendation is to collaborate with an accountant specialized in the medical field and implement an electronic patient management system to ensure tax traceability.