Clinical investigation of a medical device is any planned, lawful and systematic activity performed within the framework of the investigation, in order to evaluate the conformity of effect of the medical device subject to the investigation with the aims of the investigation objectively in the investigation centre.
How can I apply for approval of a clinical investigation?
The manufacturer (sponsor) has to receive a permition of the State Agency of Medicines for conducting a clinical investigation of a non-CE marked medical device in Latvia.
In order to receive the permition of the State Agency of Medicines for conducting the clinical investigation, the manufacturer (sponsor) shall, 30 days prior to the commencement of the investigation, submit the Application Form for Clinical Trial of a Medical Device.
The manufacturer is entitled to commence the investigation of medical devices bearing the CE marking, if in the opinion of the Ethics Committee a positive evaluation of the investigation is provided, no objections are made or no corrections are proposed concerning the investigation plan, and the Agency, within 30 days after receipt of the information referred to in the Regulation No. 891 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Clinical Trial of Medical Devices Intended for Human Use" adopted on 21 September 2010, has not taken a decision regarding the refusal to issue the investigation permit due to the non-compliance with the requirements referred to in this.
How long the examination of documentation takes?
Pursuant to the procedure set out in the Administrative Procedure Law, the State Agency of Medicines shall take a decision regarding the issue of the investigation permit within a month from the day the application is submitted.
If due to objective reasons it is not possible to comply with the one month time period, the State Agency of Medicines may extend it for a period not exceeding 4 months from the day the application is submitted.
How much does it cost?
Regulation No 891 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Clinical Trial of Medical Devices Intended for Human Use" adopted on 21 September 2010, prescribes, that before starting of clinical investigation the manufacturer shall submit to the State Agency of Medicines a copy of proof payment for expertise of the submitted documentation.
Payment procedure
Payment for the service should be made in accordance with the SAM Paid Service Pricelist.Please comply with the following:
Submit Payment application (see above the additional file Payment application). The file can be submitted electronically (rekini@zva.gov.lv), to post or personally at the Financial Accounting, Analysis and Planning Department (room No. 59). After submitting Payment application the State Agency of Medicines will forward an invoice. Upon making the payment, please provide invoice number and date in the payment purpose section of the payment assignment.
The payment assignment must contain a clearly legible name, surname or title of the payer and it must be signed by the payer.
- Submitting documents for receipt of an Approval must include:
- a copy of the invoice
- a payment assignment authorised by a credit institution or
- a print of the payment made via internet bank of a credit institution confirming the transaction of the payment.
Requisites
State Agency of Medicines of Latvia
Jersikas street 15, Riga, LV-1003, Latvia
VAT reg. No. LV90001836181
Riga settlement center of the Treasury
LV24TREL9290579005000
BIC TRELLV 22- Submitting documents for receipt of an Approval must include:
Report forms
