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OPINIONS AND CERTIFICATIONS
Voriso.com sells original products, sealed to CE standards. The products are ISO 9001 certified internationally and endorsed in Romania by the Ministry of Health.
Contact lenses with dioptres are medical devices. Marketing of medical devices (in specialized stores or online) is subject to the legal rules established by the Ministry of Health.
Marketing of these products without authorization from the Ministry of Health is strictly forbidden. The legal provisions apply to both legal entities and individuals. All medical devices must be notified to the Ministry of Health.
Contact lenses are medical devices of category IIB; maintenance and cleaning solutions are in category IIB.
The following laws regulate the commerce with medical devices: Law 176/2000, Health Minister Order No. 253/2010, GD 54/2009.
Here are some articles in the current legislation. If you want to study all the laws, you can find them on the health ministry's website, to the chapter "medical devices".
Our facility is licensed to sell contact lenses.
Please note: do not buy contact lenses from unauthorized economic agents; you risk your health!
DECISION No. 54 of 29 January 2009 on the conditions for the placing on the market of medical devices.
For the purpose of this judgment, the terms and expressions below are defined as follows:
1. medical device - any instrument, apparatus, equipment, software, material or other article used separately or in combination, including the software intended by its manufacturer, to be specifically used for diagnostic and / or therapeutic purposes and necessary the proper functioning of the medical device, intended by the manufacturer to be used for human beings for the purpose of:
c) investigation, replacement or modification of anatomy or physiological process;
1.2. Invasive devices:
Invasive device - the device that is inserted wholly or partly into the body either through an anatomical or body surface.
4.3. Rule 15
All devices intended for use in disinfecting, cleaning, rinsing or, as the case, contact lenses hydrating are included in Class IIb.
LAW NO. 176 FROM 18 OCTOBER 2000
(1) This law establishes the legal and institutional framework for the control of medical devices, active implantable medical devices, in vitro diagnostic medical devices, put into service and used, called medical devices, as well as control of the marketing, distribution and provision of services in the field of medical devices.
The activities of marketing, distribution and provision of services in the field of medical devices are carried out in compliance with the provisions of the present law and the applicable methodological norms, approved by order of the Minister of Health.
(2) The activities provided in paragraph (1) are subject to endorsement control. Exceptions to this requirement are the activities carried out by the manufacturer of the medical devices which are the subject of these activities.
(3) The notice provided in paragraph (2) shall be issued by the Ministry of Health, in compliance with the applicable methodological norms, based on the assessment of the competence and capability of the natural or legal persons, as the case may be, to carry out the activities for which the opinion is requested.
Medical devices shall be marketed, distributed, installed and maintained for use in accordance with the intended purpose only by the natural or legal persons for whom the notice referred to in Art. 3 par. (2).
The natural persons and legal persons performing the activities provided in art. 3 par. (1) are obliged, prior to the performance of these activities, to seek the opinion provided for in Art. 3 par. (3) and to make known to the Ministry of Health any changes to the conditions underlying this opinion.
ORDIN No. 253 of 26 March 2010 on the registration of medical devices
The manufacturer, authorized representative of the manufacturer, importer or distributor established in Romania has the obligation to notify to the Ministry of Health the putting into service in Romania of medical devices of classes IIa, IIb and III;
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