3250

Authorization procedure and Trade Register aspects for CAEN 3250

Setting up a company operating under CAEN code 3250 (Manufacture of dental medical devices, apparatus and instruments) involves the standard incorporation steps at the Trade Register (ONRC), but with particularities related to additional documentation and prior approvals. When submitting the file, a sworn declaration according to Law 359/2004 is completed, by which the associate confirms compliance with the legal conditions for carrying out the activity. However, given the nature of the activity (production of medical devices), ONRC may request at incorporation or later proof of registration with the Ministry of Health or the National Agency for Medicines and Medical Devices (ANMDM). It is recommended that the main object of activity be clearly specified as „Manufacture of dental devices” and, if the company intends to also market finished products, the corresponding CAEN codes should be included (e.g. 4774 for retail trade). For the registered office, the minimum space standards and specific production facilities must be respected, and the file must include documents proving the right to use the space (lease contract, ownership deed) and, if applicable, the sanitary operating permit issued by the Public Health Directorate.

Regulatory framework, specific approvals and control institutions

Carrying out activity under CAEN 3250 is strictly regulated by medical devices legislation, transposing European directives (93/42/EEC, subsequently EU Regulation 2017/745). In Romania, the competent authority is the National Agency for Medicines and Medical Devices (ANMDM). Manufacturers must register with ANMDM and obtain a registration number for each manufactured device before placing it on the market. The company must implement a quality management system according to ISO 13485 and hold CE marking through a notified body (e.g., TÜV Rheinland). Regarding approvals, the sanitary operating permit issued by the Public Health Directorate (DSP) is mandatory, as well as fire safety permits from the Emergency Situations Inspectorate (ISU). Also, for handling and storing materials (resins, acrylates, precious metals, etc.), environmental permits from the Environmental Protection Agency may be required. Periodic controls are carried out by ANMDM (for devices), DSP (for hygiene and health), ITM (occupational safety and health) and the Environmental Guard (for hazardous waste).

Tax management, ANAF audit risk and specific accounting

From a tax perspective, companies with CAEN code 3250 are subject to standard rules: corporate income tax 16% (or micro-enterprise income tax, if conditions are met), VAT at the standard rate of 19% (with the possibility of applying VAT on collection for invoices issued to legal entities). ANAF may initiate tax inspections regarding the correctness of transaction recording, especially in relation with clients (dental clinics, practices) who are VAT payers. A specific risk relates to transfer pricing if the company imports raw materials from affiliates. Accounting must strictly track each production batch; it is mandatory to keep records of raw material inventories (alloys, ceramics, polymers) and finished products. Also, for laboratory activities (prosthodontics), a reduced VAT rate of 9% applies to supplies of dental prostheses, but only if they are made to order and delivered directly to practices. Invoices must comply with the RO e-Factura system, and correct declaration of income and expenses is done through declarations 100 and 300. Written contracts with suppliers and clients are recommended, and supporting documents must be kept for at least 10 years due to the specific liability for manufactured products.