State registration is not required for medical products and medical equipment if intended for:
· Exhibitions without the right of their further implementation; (exhibition samples of health care products and medical equipment);
· Individual treatment of rare and (or) especially serious diseases;
· Prevention and elimination of consequences of emergency situations;
· Carrying out clinical researches and (or) tests;
· Medical products manufactured in the medical equipment shops and health care products (individual orders);
· Optical eye care manufactured in optical stores;
· Diagnostic reagents that are not related to medical immunobiological preparations;
· Science research laboratory diagnostic instruments;
· Laboratory devices that are not used for disease diagnosis;
· Components included in the medical products and medical equipment, and not used as a separate product or device.
Obligatory condition of state registration, re-registration is the examination of medical devices and medical equipment carried out by the state expert organization in the sphere of medicine circulation, products of medical purpose and medical equipment. Examination is conducted by state expert organization, not directly involved in the production and manufacture of medicines, health care products and medical equipment (hereinafter — the expert organization).
Expert organization defines the term of validity of registration certificate: five years for medical products and medical equipment up to seven years respectively.
Registration certificate of medical devices and medical equipment re subject to re-registration upon expiration of current registration.
俄罗斯EAC认证中心 上海经合工业设备检测有限公司 电话:021-36411293 地址:中国上海浦东新区高科东路777号1号楼2017 邮箱: eac@cu-tr.org gost-r@163.com skype: gostchina 手机和微信WeChat:18621862553 www.cu-tr.com www.cu-tr.org www.gost.org.cn
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