1. Finnish Standards Association (SFS)

SFS is the national standards body responsible for developing and adopting Finnish Standards (SFS), most of which are based on European or international norms.

2. Finnish Safety and Chemicals Agency (Tukes)

Tukes is the primary authority for product safety in Finland. It supervises consumer goods, electrical and pressure equipment, chemicals, construction products, and other technical sectors.

3. Finnish Transport and Communications Agency (Traficom)

Traficom manages the type approval of telecommunications and radio equipment, ensuring devices comply with EU and national frequency and safety standards.

4. Finnish Food Authority

This agency ensures food and agricultural product safety, including food labeling, hygiene, and compliance with EU regulations on food additives, supplements, and packaging.

5. Finnish Medicines Agency (Fimea)

Fimea regulates pharmaceuticals and medical devices. It handles product registration, clinical trials, and post-market surveillance.

Product Certification and Compliance Requirements

• CE Marking: Products within the scope of EU harmonized legislation (e.g., electrical appliances, toys, PPE, machinery, medical devices) must bear the CE mark. This indicates conformity with relevant EU directives and regulations.

• Conformity Assessment: Depending on the product risk, assessment may be performed by the manufacturer or a third-party notified body. The manufacturer must issue a Declaration of Conformity and retain a technical file.

• Labeling Requirements: Labels must be in Finnish and Swedish (both official languages) and include product name, usage instructions, manufacturer/importer contact details, country of origin, safety warnings, batch/serial numbers, and other sector-specific information.

• Product Registration: Specific products like pharmaceuticals, cosmetics, biocides, and food supplements must be registered with the relevant authority (e.g., Fimea or Finnish Food Authority) prior to being marketed.

• Environmental Compliance: Products must meet environmental obligations under EU directives such as RoHS (restriction of hazardous substances), WEEE (electronic waste), REACH (chemical safety), and energy labeling laws.

• Market Surveillance: Tukes and other agencies conduct inspections, testing, and enforcement actions to ensure ongoing product safety and regulatory compliance. Non-compliant goods may be fined, recalled, or banned.