8623

Authorization procedure and Trade Register aspects for CAEN 8623

For registration with the Trade Register (ONRC) of an LLC (SRL) or self-employed person (PFA) having as main activity CAEN 8623 (Dental practice activities), the standard setup procedure applies, but with additional formalities due to the medical specificity. The establishment of a company (SRL) is done by application submitted to the Trade Register office, while for PFA the simplified procedure is followed. The constitutive acts must clearly specify the CAEN code 8623. However, the law requires prior authorizations. For dental offices, obtaining the sanitary operating permit issued by the Public Health Directorate (DSP) of the county is mandatory, according to Law 95/2006 and technical norms. Also, to operate legally, a contract with the Health Insurance House (CNAS) must be concluded if reimbursed services are offered. At ONRC, a sworn declaration according to Law 359/2004 will also be submitted, by which the administrator attests to holding the necessary permits. No additional formalities are required compared to other medical offices, but it is recommended to check the premises in advance (hygiene conditions, access for disabled persons). Regarding publication in the Official Gazette, it is mandatory only for SRLs, not for PFAs.

Regulatory framework, specific permits and control institutions

Dental practice activities are strictly regulated. In addition to the DSP permit, offices must comply with the sanitary authorization rules provided by Ministry of Health Order 1761/2021. The dentist must be a member of the College of Dentists of Romania (CMD) and hold a membership certificate with the right to practice for general dentistry or pedodontics. For offices using radiation equipment (e.g., dental X-rays), a permit from the National Commission for Nuclear Activities Control (CNCAN) is required. The complete list of permits includes: DSP permit, operating authorization from CMD for office registration, a contract with a sanitation company for hazardous medical waste (according to Government Decision 856/2002), and, where applicable, an ISU permit for fire safety. The main control is carried out by DSP and CMD, but also by ANAF (tax audits regarding declared income and fiscal receipts). Relevant legislation includes Law 95/2006 on healthcare reform, Ministry of Health Order 961/2016 on the establishment and operation of offices, and the Fiscal Code (Law 227/2015).

Tax management, ANAF audit risk and specific accounting

From a tax perspective, dental offices are payers of corporate income tax (16%) or income tax (for PFA/II), unless they exceed the threshold for micro-enterprises. For SRLs with 1-2 employees, the micro-enterprise income tax system (1% of turnover) may apply, but only if revenues do not exceed 500,000 euros and personnel conditions are met. VAT: medical activities are exempt from VAT (art. 292 para. 1 letter a of the Fiscal Code), but with only partial deduction rights. Correct registration for VAT purposes with ANAF is essential. Also, offices are required to issue electronic invoices through the RO e-Factura system for B2B relationships (from January 1, 2024). ANAF audit risk: the most frequent risk is incomplete recording of revenues (informal economy) and incorrect declaration of employees (collaborating doctors). Employment contracts or civil agreements for doctors are recommended, with withholding of taxes and contributions. Accounting is kept on a double-entry basis (for SRL) or single-entry (for PFA). Monthly obligations include: declaring issued and received invoices in D406 (SAF-T), VAT return (if taxation option exists), and declarations 112 and 100 monthly. Doctors' salaries can be deducted, provided the ceilings and legal contracts are respected. Expenses for dental materials are deductible with invoice, and those for investments (chairs, equipment) are amortized. Personal expenses of the associate cannot be deducted. Strict management of material stocks (biphasic, anesthetic gases) and hazardous waste is required, which must be accounted for.