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Article 3
The Agency shall be responsible for the following:
1) Performs registration of a medical device, amendments and additions, renewal of registration, as well as removal of a medical device from the Register of Medical Devices;
2) Keeps the Register of Manufacturers, or authorised representatives of the manufacturers (hereinafter: the Register of Manufacturers), performs amendments and additions and removals from the Register of Manufacturers;
3) Approves the implementation, amendments and additions to the approval for the conduction of the clinical trial, confirms the report of the clinical trial and approves the import of clinical trial products in accordance with this Law, and also controls the conduction of the clinical trial;
4) Assess the compliance of the medical device with the requirements of the monograph of the national pharmacopoeia, as well as the applicable European pharmacopoeia or international pharmacopoeia;
5) Performs recognition of foreign documents and markings of conformity;
6) Performs a technical assessment of the medical device on the market with the requirements of the national pharmacopoeia monograph, as well as the applicable European pharmacopoeia or international pharmacopoeia, as well as with the requirements of the manufacturer's standards and methods;
7) Performs surveillance of the medical device on the market, conducts a vigilance and participates in the planning and implementation of systematic control of medical devices and taking random samples from the market;
8) Approves the import of a medical device for the treatment of a particular patient or group of patients, the import of a medical device as a donation or humanitarian aid, or a grant program in the European Union, a medical device for scientific research, as well as in case of an emergency situation in accordance with the law;
9) Controls the promotional material for the advertising of a medical device, on the proposal of the Ministry;
10) Collects and processes data on Marketing and consumption of medical devices;
11) Determines the status of the product, i.e. determines whether a particular product is a medical device;
12) Gives opinion on the classification and categorization of the medical device, at the request of the Ministry;
13) Cooperates with international information networks on medical devices and with agencies responsible for medical devices and their associations;
14) Grants approval for the import and export of samples of cells or tissues for the clinical trial procedure;
15) Issues a Free sale certificate for a medical device that has been placed on the market or in use;
16) Informs the general and professional public, as well as performs continuous medical education, in accordance with the law, and prepares and publishes professional publications within the competence of the Agency;
17) Provides professional advice at the request of legal or natural persons in connection with:
(1) the translation of the instructions for use and the marking of a medical device,
(2) classification of a medical device in the class and category of medical devices;
18) Performs other duties, in accordance with the law.
The tasks referred to in paragraph 1 items 1), 3), 4), 5), 6), 8), 11) and 14) of this Article, the Agency performs as the entrusted tasks.
The operations referred to in paragraph 1 of this Article may be performed in electronic form in accordance with the law governing electronic commerce.
In the performance of the entrusted tasks referred to in paragraph 2 of this Article, the law governing the general administrative procedure shall be applied, unless otherwise provided by this Law.
The Minister shall prescribe the criteria and manner of determining the status of products referred to in paragraph 1, item 11) of this Article.
