4774
Retail sale of medical and orthopaedic articles
This code covers the retail sale of medical and orthopaedic articles, including medical care products, orthopaedic devices and prostheses. Activities are carried out in specialized stores, pharmacies or online, targeting patients, persons with disabilities or athletes. It is essential for any business selling non-prescription medical or orthopaedic equipment directly to consumers.
Entrepreneur Profile
Acest cod este potrivit pentru antreprenorii care deschid magazine specializate în articole medicale și ortopedice, farmaciști care extind gama de produse nefarmaceutice, terapeuți sau kinetoterapeuți care vând dispozitive de recuperare, precum și pentru comercianții online care livrează astfel de produse către pacienți sau sportivi.
Who should avoid:
Avoid the exclusive use of code 4774 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 NACE 4774
For registration with the Trade Register (ONRC) of the company having as its main activity the NACE code 4774 (retail sale of medical and orthopaedic articles), you submit the standard application, the constitutive act, the affidavit under Law 359/2004 and supporting documents for premises and storage spaces. When completing secondary activities, check compatibility with the health authorization regime. The Trade Register requests, in certain cases, the opinion of the Ministry of Health or the Public Health Directorate, depending on the nature of the articles (medical vs. orthopaedic).
Regulatory framework, specific permits and control institutions
The marketing of medical and orthopaedic articles requires compliance with the provisions of Ministry of Health Order no. 961/2016 on the distribution of medical devices. Orthopaedic articles are classified as class I (simplified authorization) or class II (notification to the National Agency for Medicines and Medical Devices). You need a health operating authorization issued by the territorial Public Health Directorate, which verifies storage, labeling and hygiene conditions. Control is carried out by the Public Health Directorate, the National Authority for Consumer Protection and the Tax Authority (ANAF) depending on the specifics.
Tax management, audit risk and specific accounting
From a fiscal point of view, the company registers with the Tax Authority (ANAF) with the corresponding tax vector (VAT payer upon exceeding the threshold of RON 300,000 according to the Fiscal Code). Taxation is at the standard rate of 19% for most non-exempt medical articles; some devices may be exempt with the right of deduction. You submit D300, D394 returns and the RO e-Factura system for B2B invoices. Inventory accounting is done per product batch, checking expiration dates and receipt documents. Tax audit risk: VAT corrections may arise due to lack of supporting documents for imports or purchases from unauthorized manufacturers.
Included Activities
- ✅ Retail sale of medical and orthopaedic articles
- ✅ Sale of prostheses and orthoses
- ✅ Retail sale of non-implantable medical devices
- ✅ Sale of home medical care articles
- ✅ Retail sale of orthopaedic articles (corsets, splints, etc.)
- ✅ Sale of crutches, canes, walking frames
- ✅ Retail sale of prosthetic and orthopaedic articles
- ✅ Sale of incontinence articles
- ✅ Retail sale of therapeutic massage articles
- ✅ Sale of physiotherapy and rehabilitation articles
Excluded Activities
- ❌ Retail sale of pharmaceutical products (code 4773)
- ❌ Retail sale of cosmetic and toilet articles (code 4775)
- ❌ Manufacture of medical and orthopaedic articles (code 3250)
- ❌ Wholesale of medical and orthopaedic articles (code 4646)
- ❌ Renting of medical and orthopaedic articles (code 7730)
- ❌ Repair of medical devices (code 3313)
Similar or Related CAEN Codes:
From the same category of economic activities:
Întrebări Frecvente
What authorizations are required for the retail sale of medical and orthopaedic articles?
For this NACE code, no special authorization from the Ministry of Health is required, but the regulations on labeling and product safety must be observed. If medical devices are sold, they must bear the CE marking. Also, registration with the Trade Register and obtaining the operating authorization from the town hall are necessary.
Can I sell medical and orthopaedic articles online with this NACE code?
Yes, code 4774 allows retail sale both in physical stores and online. You must comply with the legislation on electronic commerce (Government Emergency Ordinance 34/2014) and have clear terms and conditions. For medical devices, a notification to the National Agency for Medicines and Medical Devices (ANMDMR) is required if you sell such products online.