2660
Manufacture of radiology, electrodiagnostic and electrotherapy equipment
This code covers the manufacture of medical equipment used in radiology, electrodiagnosis and electrotherapy, including X-ray machines, CT scanners, ultrasound machines, pacemakers and defibrillators. Activities include the production of components, assembly and testing of these devices, as well as the development of dedicated software. It is a high-tech field strictly regulated by medical and safety standards.
Entrepreneur Profile
Acest cod este potrivit pentru producători de echipamente medicale, atât startup-uri inovatoare, cât și fabrici consacrate, care dezvoltă și produc dispozitive de radiologie, electrodiagnostic sau electroterapie. De asemenea, este util pentru companii care oferă servicii de mentenanță și reparații pentru propriile echipamente fabricate.
Who should avoid:
Avoid the exclusive use of code 2660 if the main activity of your company shifts towards other commercial or related branches not specified in the official description. See the excluded activities section below.
Authorization Procedure and Trade Register Aspects for CAEN 2660
Setting up a company carrying out the activity of manufacturing radiology, electrodiagnostic and electrotherapy equipment (CAEN 2660) requires going through the standard formalities at the Trade Register (ONRC), but with particularities related to the object of activity. Upon registration, the sworn declaration according to Law 359/2004 must be submitted, by which the administrator confirms compliance with legal conditions. It is essential to explicitly mention in the articles of association the main activity object CAEN 2660, without using generic names. The Trade Register (ONRC) does not require prior approvals for registration, but for operation additional authorizations are necessary. Also, in case of a subsequent change of the object of activity (adding or renouncing CAEN 2660), the specific form accompanied by the shareholders' resolution must be submitted to the Trade Register (ONRC). It is recommended to check the CAEN code in the Statistical Nomenclature before drafting the documents, to avoid incorrect classifications that may lead to refusal by the registrar.
Regulatory Framework, Specific Approvals and Control Institutions
Activities under CAEN 2660 are subject to national and European regulations on medical devices. In Romania, the competent authority is the Ministry of Health and the National Agency for Medicines and Medical Devices (ANMDMR). Manufacturers must obtain CE certification in accordance with Regulation (EU) 2017/745 on medical devices (MDR). Radiology equipment is also subject to nuclear safety regulations, requiring authorization from the National Commission for Nuclear Activities Control (CNCAN). Furthermore, production involves compliance with occupational safety standards and regulations on waste electrical and electronic equipment (WEEE), controlled by the National Environmental Guard. For marketing, registration in the national medical devices system and notification to ANMDMR are required. Lack of approvals may lead to penalties and even suspension of activity. It is recommended to consult a lawyer specialized in pharmaceutical and medical regulations to identify all prior authorizations for operation.
Tax Management, ANAF Audit Risk and Specific Accounting
From a tax perspective, a company carrying out CAEN 2660 is liable for corporate income tax or micro-enterprise income tax if it meets the threshold conditions (turnover below EUR 1,000,000 and at least one employee). Registration in the RO e-Factura system is mandatory for all supplies of goods and services between taxable persons, regardless of value. Standard VAT rates (19%) or reduced rates (5%) apply to medical devices if included in the list approved by the Ministry of Health. Accounting must separately reflect research and development costs, raw material purchases, and finished goods inventories. The Tax Authority (ANAF) may initiate a tax audit on the recording of revenues, correctness of VAT rate application, and supporting documents. A major risk is the non-declaration of intra-Community transactions or failure to register purchases from non-resident suppliers. It is recommended to keep separate records by development projects and implement an internal control system to comply with the specific tax regime for medical devices.
Included Activities
- ✅ Manufacture of X-ray machines for medical or veterinary use
- ✅ Manufacture of computed tomography (CT) equipment
- ✅ Manufacture of magnetic resonance imaging (MRI) equipment
- ✅ Manufacture of ultrasound machines
- ✅ Manufacture of pacemakers
- ✅ Manufacture of defibrillators
- ✅ Manufacture of electrotherapy apparatus
- ✅ Manufacture of electrodiagnostic apparatus (e.g., EEG, ECG)
- ✅ Manufacture of dental radiology equipment
- ✅ Manufacture of spare parts and accessories for this equipment
- ✅ Development of dedicated software for manufactured equipment
- ✅ Repair and maintenance of own equipment (as secondary activity)
Excluded Activities
- ❌ Manufacture of medical furniture (code 3109)
- ❌ Manufacture of surgical and dental instruments (code 3250)
- ❌ Manufacture of contact lenses and spectacles (code 3250)
- ❌ Manufacture of medical consumables (code 2120)
- ❌ Retail trade of medical equipment (code 4774)
- ❌ Installation of medical equipment (code 3320)
- ❌ Research and development activities in the medical field (code 7211)
Similar or Related CAEN Codes:
From the same category of economic activities:
Întrebări Frecvente
What authorizations are necessary for manufacturing radiology equipment in Romania?
Authorization from the National Commission for Nuclear Activities Control (CNCAN) is required for equipment emitting ionizing radiation, as well as CE certification under Directive 93/42/EEC on medical devices. Registration with the National Agency for Medicines and Medical Devices (ANMDM) is also mandatory.
Can I manufacture electrotherapy equipment without holding a medical device certificate?
No. All electrotherapy equipment is considered a medical device and must comply with Regulation (EU) 2017/745 (MDR). CE certification through a notified body is mandatory, and the manufacturer must implement a quality management system according to ISO 13485.