Moldova is actively developing and harmonizing its product compliance framework to align with European Union regulations, especially under the EU–Moldova Association Agreement. The country has adopted numerous EU technical regulations, including CE marking, and enforces national conformity assessment procedures, especially for electrical products, medical devices, telecom, and consumer goods.

Key Authorities:

• Institute for Standardization of Moldova (ISM) – Develops national standards (SM) and coordinates harmonization with EN (European) and international standards.

• National Agency for Regulation of Nuclear and Radiological Activities (NARNRA) – Oversees safety for specific industrial products and equipment.

• Agency for Consumer Protection and Market Surveillance (APCSP) – Conducts market inspections, enforces CE marking rules, and monitors product safety.

• Medicines and Medical Devices Agency (MMDA) – Regulates pharmaceuticals, medical devices, cosmetics, and health supplements.

• National Regulatory Agency for Electronic Communications and Information Technology (ANRCETI) – Manages telecom and RF equipment approval.

• Moldovan Customs Service – Verifies import documentation and ensures conformity with technical regulations.

Key Compliance Elements:

• CE Marking & Harmonized Regulations:

  • Moldova has adopted many EU directives into national law and allows CE-marked products to be placed on its market.

  • This applies to categories like:

    • Electrical and electronic equipment

    • Toys

    • Machinery

    • Personal protective equipment

    • Medical devices

  • A Declaration of Conformity (DoC) and technical file are required for CE-regulated goods.

• Product Registration:

  • Required for:

    • Medicines and vaccines (MMDA)

    • Medical devices and diagnostics (MMDA)

    • Cosmetics and supplements

  • Requires safety and efficacy documentation, GMP or ISO certificates, and labeling review.

• Telecom Type Approval (ANRCETI):

  • All telecom and RF equipment must be type approved by ANRCETI.

  • CE-certified products may undergo simplified approval procedures, but formal registration is still required.

• Labeling Requirements:

  • Labels must be in Romanian, and include:

    • Product name

    • Manufacturer/importer contact

    • CE mark (if applicable)

    • Usage instructions and safety warnings

    • Batch/expiry date (for health-related goods)

    • Country of origin

• Environmental Compliance:

  • Moldova has introduced legislation based on EU WEEE, RoHS, and REACH directives.

  • Producers may be required to register with local waste schemes or compliance programs.

• Import Oversight:

  • Importers must present:

    • DoC or conformity certificates

    • Certificate of origin

    • Invoice and packing list

    • Product registration (for regulated goods)

• Market Surveillance:

  • Conducted by APCSP and other agencies. Non-compliant goods may be fined, recalled, or removed from the market.