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乌兹别克斯坦医疗器械认证,乌兹别克斯坦医疗器材注册,REGISTRATION OF HEALTH CARE EQUIPMENT AND MEDICAL DEVICES IN UZBEKISTAN, state registration and re-registration of if imported to Uzbekistan taking into account their classification depending on degree of potential risk in medica
来源: | 作者:pmt93305e | 发布时间: 2018-11-09 | 19 次浏览 | 分享到:

REGISTRATION OF HEALTH CARE EQUIPMENT AND MEDICAL DEVICES IN UZBEKISTAN

乌兹别克斯坦医疗器械认证,乌兹别克斯坦医疗器材注册,
state registration and re-registration of if imported to Uzbekistan taking into account their classification depending on degree of potential risk in medical applications, including the following

Health care equipment and medical devices produced in Kazakhstan are eligible for state registration and re-registration of if imported to Uzbekistan taking into account their classification depending on degree of potential risk in medical applications, including the following:

  • medical products and medical equipment registered earlier in the Republic of Kazakhstan, but produced in other modifications, new packaging, a different composition of parts or different name;
  • medical products and medical equipment registered earlier in the Republic of Kazakhstan, but produced by other organizations-producers;
  • medical products and medical equipment produced by one manufacturer at the production sites located (hosted) in different countries;
  • medical devices and medical technology, registered in the producing country and (or) in the country of the holder of the production license;
  • medical products or medical appliances, having the medicine in the composition or being its integral part, are subject to state registration, re-registration as medical devices or medical equipment;
  • medical devices or medical technology, having a coverage of a medicine is subject to state registration, re-registration as a medical device or medical equipment;
  • medical products and medical equipment that include specialized vehicles to delivering medical aid;
  • medical products for conception control;
  • products of medical purpose and medical equipment for replacement and modification of parts of tissues, human organs; recovery or reparation of disrupted or lost physiological functions;
  • medical devices used for diagnostics outside the human body, except for the diagnostic reagents that are not related to medical immunobiological samples, as well as contact lenses for vision correction;
  • sets (sets) products of medical purpose;
  • laboratory diagnostic instruments;
  • medical devices and medical equipment intended for the prevention, diagnosis, treatment of diseases, assessment of the physiological state of the organism, rehabilitation, medical procedures, research of a medical character;
  • consumables for medical purpose products and medical equipment which are medical devices, except as specifically intended by the manufacturer for use with medical devices and medical equipment, capable to operate only with consumable;

The medicine registered in the country of manufacturer as medical products, with its characteristics and properties related to medicines, are subject to assessment as medicines.

A medicine included in the medical products and medical equipment or as a constituent part, is a specialized examination provided for medicines.

A medical product or medical technology, having a medicine coverage subject to state registration, re-registration as health care products or medical equipment.

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.

Medreg provides services on conducting the entire sequence of registration/ re-registration of medical devices, health care products from the preparation of the registration documents until obtaining a registration certificate in accordance with the legal requirements of Republic of UZBEKISTAN. The period of preparation of the registration documents for submission depends on the quality of the source documents and conditions, which negotiated with the client.