1. Czech Office for Standards, Metrology and Testing (ÚNMZ)

ÚNMZ is the national authority responsible for standardization, legal metrology, and conformity assessment policy. It adopts and coordinates Czech technical standards based on international and European norms.

2. Czech Trade Inspection Authority (ČOI)

ČOI is responsible for market surveillance and consumer protection. It inspects product compliance, labeling, and general safety across sectors including electronics, textiles, toys, and food contact materials.

3. Ministry of Industry and Trade

This ministry oversees national conformity assessment infrastructure, notifies EU about technical regulations, and supports economic operators in applying EU product rules.

4. Institute for Testing and Certification (ITC)

ITC is one of several notified bodies that carry out testing, certification, and inspection services for regulated products, such as medical devices and pressure equipment.

5. State Institute for Drug Control (SÚKL)

SÚKL regulates pharmaceuticals and medical devices. It manages product registration, clinical trials, pricing, and post-market surveillance.

6. Ministry of Health

Responsible for public health-related regulations including food safety, cosmetics, biocides, and chemicals.

Product Certification and Compliance Requirements

• CE Marking: Products within the scope of EU harmonized legislation (e.g. low-voltage electrical equipment, toys, machinery, PPE) must bear the CE mark before being sold in Czechia. This confirms compliance with essential EU requirements.

• Conformity Assessment: Depending on the risk level of the product, assessment may involve internal control, testing by a notified body, or third-party certification. Documentation like the Declaration of Conformity is required.

• Labeling Requirements: Labels must be in Czech and include product name, manufacturer/importer contact information, country of origin, instructions, warnings, batch or serial numbers, and, where applicable, CE marking.

• Product Registration: Products such as pharmaceuticals, food supplements, cosmetics, and some electronics may require registration with specific authorities before being placed on the market.

• Market Surveillance: The Czech Trade Inspection Authority and other sectoral bodies perform checks to ensure continued compliance. Non-compliant products may be recalled, fined, or restricted from sale.

• Environmental and Safety Compliance: Products must meet EU standards on energy efficiency, RoHS (hazardous substances), WEEE (waste electronics), and packaging waste requirements.