Romania, as a European Union member state, fully implements all EU product compliance regulations, including CE marking, REACH, RoHS, WEEE, eco-design, and other harmonized directives. All products sold or imported into Romania must meet EU-level safety, health, and environmental protection standards.

Key Authorities:

• Romanian Standards Association (ASRO) – Develops and maintains Romanian Standards (SR), harmonized with EN, ISO, and IEC.

• National Authority for Consumer Protection (ANPC) – Conducts market surveillance, enforces CE marking, and oversees product recalls.

• National Agency for Medicines and Medical Devices of Romania (ANMDMR) – Regulates pharmaceuticals, medical devices, and health products.

• National Authority for Management and Regulation in Communications (ANCOM) – Oversees telecom and RF compliance, including RED enforcement.

• Romanian Customs Authority (Vama) – Checks documentation and regulatory compliance for all imports.

Key Compliance Elements:

• CE Marking:

  • Required for all EU-regulated product categories, such as:

    • Electrical and electronic devices

    • Machinery and construction products

    • Toys, PPE, and medical devices

  • Products must:

    • Bear the CE mark

    • Be backed by a Declaration of Conformity (DoC)

    • Include complete technical documentation

• Product Registration:

  • Required for:

    • Medicines and vaccines (via ANMDMR or EMA)

    • Medical devices (via EUDAMED)

    • Cosmetics and food supplements (via EU portals, e.g., CPNP)

  • EU-level registration is valid in Romania without additional national procedures.

• Telecom Equipment (ANCOM):

  • Must comply with the EU Radio Equipment Directive (RED).

  • CE-marked devices that meet RED requirements can be placed on the Romanian market without separate national approval.

  • ANCOM may conduct spot checks or request technical files.

• Labeling Requirements:

  • Labels must be in Romanian, and include:

    • Product name

    • Manufacturer/importer contact

    • Country of origin

    • CE mark (if applicable)

    • Instructions and warnings

    • Expiry or batch number (for regulated items)

• Environmental Compliance:

  • Romania enforces all EU environmental legislation, including:

    • RoHS (for electronics)

    • REACH (chemical safety)

    • WEEE (e-waste management)

    • Eco-design and energy labeling

• Import Oversight:

  • Importers must ensure:

    • CE/DoC documentation is available

    • Registration with EU portals (if applicable)

    • Invoice, packing list, and certificate of origin

    • Customs declaration via EU TARIC system

• Market Surveillance:

Conducted by ANPC, ANCOM, ANMDMR, and Customs. Enforcement includes product recalls, fines, and public notices for non-compliance.