8691

Authorization procedure and Trade Register aspects for CAEN 8691

For registration with the Trade Register (ONRC) of an LLC that will carry out activities under CAEN 8691, a file must be submitted including the Articles of Incorporation, the standard application, proof of registered office and the right to use the space (lease agreement / loan for use registered with the Tax Authority (ANAF) or title deed). The premises must meet the technical-sanitary conditions required by the Public Health Department (DSP), so it is recommended to obtain the DSP approval before registration.

The main activity will be explicitly mentioned: "8691 – Medical diagnostic imaging services and activities of medical laboratories". Depending on the specifics, secondary CAEN codes may be added, such as 8690 (other medical activities) or 7120 (technical analysis and testing).

The DSP approval is mandatory. The county Public Health Authority will inspect the premises, equipment, patient flow, and medical waste. Without this approval, the ONRC cannot finalize the registration.

After registration, a sworn declaration according to Law 359/2004 for the authorization of operation is submitted to the ONRC (specific operating conditions must be fulfilled). The company must request sanitary registration from the DSP (according to Order 1030/2009) and obtain an operating license from the Ministry of Health, if applicable.

For laboratory authorization, the accreditation procedure according to Order 1301/2007 is carried out, including inspection and issuance of a decision (valid for 5 years). Note that medical analyses can only be performed in accredited laboratories, and the physicians performing the diagnosis must be specialists.

Regulatory framework, specific approvals, and control institutions

The field is strictly regulated by the Ministry of Health and the National Authority for Quality Management in Health (ANMCS). Laboratories must implement a quality management system according to SR EN ISO 15189 (medical laboratories) and be periodically inspected.

Controls are carried out by: DSP (current sanitary control), ANMCS (accreditation), CNAS (reimbursements), ANPC (consumer protection) – especially regarding patient relations.

In the case of reimbursement of services by health insurance funds, a contract with CNAS is required; for this, the laboratory must be accredited and meet the minimum staff and equipment conditions.

Required approvals include: DSP approval, ISU approval (fire safety), environmental approval (for medical waste), operating authorization issued by the Public Health Department (according to Law 95/2006), and, where applicable, approval from the Disciplinary Commission of the College of Physicians.

For radiology or imaging activities: approval from CNCAN (National Commission for Nuclear Activities Control) – for equipment emitting ionizing radiation.

Employed staff (radiologists/specialists, laboratory assistants) must be registered with the College of Physicians/Order of Medical Assistants, and the laboratory must keep a register of patients and analyses.

Tax management, ANAF audit risk, and specific accounting

The company will be liable for micro-enterprise tax if it meets the staff and revenue conditions (turnover under EUR 500,000, at least 1 employee).

The fiscal vector is submitted to ANAF after registration to correctly classify the fiscal activity. The RO e-Factura system is required for all invoices to individuals (patients) and legal entities (clinics, hospitals).

Accounting must distinctly reflect revenues from medical services (with VAT rates: 9% for medical services according to the Fiscal Code, art. 291, para. (2), letter a) and the correct application of exemptions for medical analyses (exempt from VAT if performed by authorized medical staff in accredited laboratories).

ANAF audit risk: medical activities are frequently checked for the correct application of VAT (exemption/9% VAT), declarations regarding fee income, contracts with CNAS (fictitious reimbursements), and compliance with cash register regulations (recording revenues collected directly from patients). It is recommended to use a fiscal cash register and the RO e-Factura system.

Income taxation: revenues from medical services are recorded as service revenue. If fees are charged for consultations or interpretations, they are taxable. Deductible expenses include equipment purchase (depreciation), consumables, personnel costs, rent, licenses, maintenance, decontamination, etc.

The Unified Declaration is completed by the administrator/shareholder for income from dividends or other sources, if applicable. The company must submit D100 (monthly/quarterly declarations), D112 (payroll obligations), and D300 (VAT return).

A specific aspect: reimbursements from CNAS are made based on contracts, and discrepancies may lead to reduced amounts or even exclusion from the system. Therefore, analytical accounting for each contract is crucial.