Latvia Medical Device Registration

Medical Device Regulations in Latvia: Compliance, Registration, and Market Overview 

Regulatory Authority

State Agencies of Medicines

The State Agency of Medicines of Latvia (SAMLV) is a state institution under the Ministry of Health of Latvia, tasked with implementing local and international pharmaceutical legislation to ensure the compliance of products and companies in healthcare.

SAMLV operates non-financed, relying on revenue from paid services and approved by the Cabinet of Ministers. Its functions include ensuring effective, safe, and qualitative medicinal products are included in the Drug Register, inspecting compliance, certification, and licensing of companies, monitoring medicine safety, evaluating clinical trial projects, evaluating medical technology cost-effectiveness, providing objective information, and participating in the European medicines network.

Link for Regulatory Authority

https://www.zva.gov.lv/en/industry/medical-device-manufacturers-authorized-representatives/being-placed-market

Local Regulation

• State Agencies of Medicines
• Regulation No. 461 of the Cabinet of Ministers of the Republic of Latvia Medical Devices Regulation

https://www.zva.gov.lv/en/legislation

Classification of Medical Devices

Class I, lla, llb, III

Listing or Registration Requirements

Class IIa, class IIb, class III medical devices, active implantable medical devices and IVD medical devices referred to in List A and List B, as well as medical devices for self-testing must submit to the State Agency of Medicines

submit a notification form electronically in the information system LATMED

Documents Required

• The Statement Form and copies of EC Declaration of Conformity and CE certificates
• It is allowed to place a medical device on the market, if it complies with the requirements of legislation, the relevant conformity assessment procedures have been performed, the EC conformity declaration has been made and the device is labelled with the CE marking.

Registration Timeline 

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device 

Registration Fee

There are no fees for notification and registering medical devices at the national medical devices database

License Validity

5 Years

Special Labelling Requirements

IFU Label in Latvian language

Additional Comments

The Latvian government has adopted two new regulations on medical devices, which came into effect on May 25, 2017, replacing existing Directives. The new rules will only apply after a transitional period, three years after the Regulation on medical devices (spring 2020) and five years after the Regulation on in vitro diagnostic medical devices (spring 2022). 

The current legislation requires manufacturers or their authorized representatives to submit a statement to the State Agency of Medicines before placing class IIa, IIb, and III medical devices, active implantable medical devices, and IVD medical devices on the Latvian market. Class I and IVD medical devices are not mandatory. 

If an authorized representative has a place of business in Latvia, they must provide the Agency with notification information and any changes. The State Agency of Medicines will receive and store information about manufacturers and their medical devices, review and store the information, and perform medical device vigilance. 

When to make this communication?

Before placing a medical device into the market.

Market overview

In 2024, the Medical Technology market in Latvia is expected to achieve a revenue of US$284.50 million, with Medical Devices representing the largest segment, reaching a market volume of US$236.30 million in the same period. Looking forward, a projected annual growth rate (CAGR 2024-2028) of 5.00% is anticipated, leading to a market volume of US$345.80 million by 2028.

Comparing the Latvian market to the global scenario, it’s noteworthy that the United States is poised to generate the highest revenue, projected at US$215.80 billion in 2024. Latvia’s medical technology market is currently witnessing a surge in innovative solutions, particularly in the areas of remote patient monitoring and telemedicine.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk