Who regulates medical devices in Finland?

The Finnish Medicines Agency Fimea is the competent authority for medical devices. It runs the national CERE register and applies the Medical Devices Act (719/2021) together with the EU MDR (2017/745) and IVDR (2017/746).

Does a Finnish distributor have to register with Fimea?

Yes, if it makes medical devices available in Finland to retailers, healthcare and social welfare operators or other professional users. Such a distributor must register as an operator in Fimea’s CERE register; Fimea’s guidance gives a supervision fee of EUR 500 for 2025. Manufacturers, authorised representatives and importers established in Finland also have to notify Fimea.

Do labels and instructions have to be in Finnish?

Instructions for devices for professional use can be in Finnish, Swedish or English. Information needed for safe use must be in Finnish and Swedish, and devices for patients or other lay users need their instructions in both Finnish and Swedish (Medical Devices Act 719/2021, section 5).

How do Finnish public hospitals buy medical devices?

Since 1 January 2023 the 21 wellbeing services counties, the City of Helsinki and the HUS Group organise public healthcare. They buy through public procurement: tenders are published in Hilma, the official notice service, and they can also use Hansel framework agreements. For goods, the national threshold is EUR 60,000 and the EU threshold for these buyers is EUR 216,000 from 2026.

Do I need a Finnish distributor to sell medical devices in Finland?

Not by law: an EU manufacturer can sell directly. In practice most foreign manufacturers work with a Finnish distributor that already sells to hospitals or care units, takes part in tenders, holds stock and gives local service and training.

Can Fractio find medical device distributors in Finland for my product?

Yes. The Nordic Distributor Radar lists 15–25 distributors or agents in one country that already sell comparable products, with channel, contact person and fit note. It costs €490 per country, excl. VAT, and is delivered in 5 business days. See the Radar.

Medical Device Distributors in Finland

Contents1. Who buys medical devices in Finland 2. Distributor, importer or agent 3. Fimea, MDR and language rules 4. Public tenders: Hilma and Hansel 5. How to choose a distributor Questions

1. Who buys medical devices in Finland

Buyer	What it is	How a foreign manufacturer usually gets in
Wellbeing services counties, City of Helsinki and HUS	Since 1 January 2023, 21 wellbeing services counties organise primary and specialised healthcare. Helsinki organises its own services, and the HUS Group handles demanding specialised care in Helsinki and Uusimaa.	Public tenders, usually answered by a Finnish distributor that offers the product, delivers, trains staff and gives service.
Free care supplies for patients at home (hoitotarvikejakelu)	The counties give patients with long-term conditions care supplies free of charge, for example diabetes, stoma, wound care and catheter supplies and incontinence products. The products are contract products chosen through the county’s tenders.	Through the county’s tender for that product group, normally via a distributor with home-delivery logistics.
Hansel framework agreements	Hansel is the central purchasing body for central and local government. Wellbeing services counties are among its customers and can buy from its framework agreements without a separate tender.	By being a supplier, or a supplier’s partner, in a Hansel framework or dynamic purchasing system.
Private healthcare, occupational health, dental and veterinary clinics	Private providers buy outside the public procurement rules.	Through distributors that already supply clinics of the same type, or by direct sale.
Pharmacies and retail (devices for home use)	Devices sold to consumers.	Through a distributor to the retail channel. Instructions must be in Finnish and Swedish.

Public healthcare organisation: Ministry of Social Affairs and Health. Free care supplies: example from the Vantaa and Kerava wellbeing services county; each county publishes its own rules. Hansel’s customers: Hansel. Finland also has five cooperation areas for health and social services (City of Helsinki), so a distributor that covers the whole country is worth more than one that covers one region.

2. Distributor, importer or agent

Partner	Role under the MDR	Works best when
Distributor	Makes your CE-marked device available in Finland. If you are an EU manufacturer, for example in Portugal, your Finnish partner is normally a distributor, not an importer. It checks the CE marking, labels, instructions and UDI before it sells (MDR, Article 14).	You want a partner that buys, holds stock, answers tenders and gives local service and training.
Importer	The first company to place a device from outside the EU on the EU market (MDR, Article 13). An importer established in Finland must notify Fimea.	You manufacture outside the EU and your Finnish partner is your entry point into the EU.
Agent	Presents your device to buyers and supports tenders; you or a logistics partner deliver and invoice.	You already have EU logistics and want to keep the customer relationship.

Most manufacturers start with one distributor per country. Check which brands each candidate already carries: a distributor with a competing product may not take yours, while one with complementary products already knows the buyers and the tender calendar.

3. Fimea, MDR and language rules

Fimea is the authority. The Finnish Medicines Agency Fimea supervises medical devices in Finland under the Medical Devices Act (719/2021) and the EU MDR and IVDR.
Registration. Manufacturers, authorised representatives and importers established in Finland must notify Fimea before they sell. So must a distributor that makes devices available to retailers, healthcare and social welfare operators or other professional users. It registers as an operator in Fimea’s CERE register (Medical Devices Act, section 49). Fimea’s distributor guidance gives a supervision fee of EUR 500 for such distributors in 2025.
Language. Instructions for devices for professional use can be in Finnish, Swedish or English. Information needed for safe use must be in Finnish and Swedish; the manufacturer decides which information that is through its risk analysis. Devices for patients and other lay users, and home tests, need instructions in Finnish and Swedish (section 5).
Translation by the distributor. If your distributor translates your labels or instructions, MDR Article 16 sets conditions: among them, the distributor must have a quality management system for this and inform you and the competent authority in advance.
Documents a distributor will ask for. The EU declaration of conformity, the notified body certificate where one applies, labels and instructions in the required languages, UDI data, and a contact for vigilance and field safety notices.

For what Nordic buyers check in documentation, see MDR, CE marking and ISO 13485 for buyers of medical consumables.

4. Public tenders: Hilma and Hansel

Hilma is the official service where Finnish public buyers publish notices on upcoming and ongoing tenders and their results. Searching it for your product group shows who buys, when contracts end and, from award notices, which suppliers won.
Thresholds. For goods, the national threshold is EUR 60,000. From 1 January 2026 the EU threshold for goods is EUR 216,000 for buyers such as wellbeing services counties, and EUR 140,000 for central government authorities.
Hansel. Hansel runs joint procurements as framework agreements, usually for four years, or as dynamic purchasing systems that new suppliers can join while they are open. Both are announced in Hilma.
What this means for you. A tender has a fixed calendar and fixed requirements. A distributor that already bids in your product group knows the buyers, the documents and the contract end dates. A partner that has never bid will learn on your product.

5. How to choose a distributor

Look at past tenders. In Hilma, find recent tenders and award notices for products like yours and note which suppliers took part and won.
Map the industry. Healthtech Finland (Terveysteknologia ry), the health technology industry association, publishes its member list. It is a starting point to see which companies work in your segment.
Qualify each candidate. Which wellbeing services counties and private groups it sells to, which brands it carries, whether it competes with you, whether it is registered with Fimea, whether it covers the whole country and Swedish-speaking customers, and whether it can train and service.
Contact 10–20 at a time with a short email in English, the device’s intended use and class, the documents above and an offer of samples or a demonstration.

The Nordic Distributor Radar does steps 1 to 3 for you: 15–25 distributors or agents in one country that already sell comparable products, with the channel each one reaches, the person to contact and a fit note. €490 per country, excl. VAT, delivered by email in 5 business days.

Selling in other Nordic countries as well? See the buyer maps for Sweden, Denmark and Norway, and how Fractio works with MedTech manufacturers.

Questions

Who regulates medical devices in Finland?: The Finnish Medicines Agency Fimea is the competent authority for medical devices. It runs the national CERE register and applies the Medical Devices Act (719/2021) together with the EU MDR (2017/745) and IVDR (2017/746).
Does a Finnish distributor have to register with Fimea?: Yes, if it makes medical devices available in Finland to retailers, healthcare and social welfare operators or other professional users. Such a distributor must register as an operator in Fimea’s CERE register; Fimea’s guidance gives a supervision fee of EUR 500 for 2025. Manufacturers, authorised representatives and importers established in Finland also have to notify Fimea.
Do labels and instructions have to be in Finnish?: Instructions for devices for professional use can be in Finnish, Swedish or English. Information needed for safe use must be in Finnish and Swedish, and devices for patients or other lay users need their instructions in both Finnish and Swedish (Medical Devices Act 719/2021, section 5).
How do Finnish public hospitals buy medical devices?: Since 1 January 2023 the 21 wellbeing services counties, the City of Helsinki and the HUS Group organise public healthcare. They buy through public procurement: tenders are published in Hilma, the official notice service, and they can also use Hansel framework agreements. For goods, the national threshold is EUR 60,000 and the EU threshold for these buyers is EUR 216,000 from 2026.
Do I need a Finnish distributor to sell medical devices in Finland?: Not by law: an EU manufacturer can sell directly. In practice most foreign manufacturers work with a Finnish distributor that already sells to hospitals or care units, takes part in tenders, holds stock and gives local service and training.
Can Fractio find medical device distributors in Finland for my product?: Yes. The Nordic Distributor Radar lists 15–25 distributors or agents in one country that already sell comparable products, with channel, contact person and fit note. It costs €490 per country, excl. VAT, and is delivered in 5 business days. See the Radar.

Sources

Rules, thresholds and fees change. Check the official source before you label, price or bid. Checked on 23 October 2026.