俄羅斯認(rèn)證,GOST認(rèn)證,eac認(rèn)證 CUTR認(rèn)證,俄羅斯標(biāo)準(zhǔn)認(rèn)證集團(tuán) Certification Center JSC "Standard Group" E-mail eac@cu-tr.org
服務(wù)熱線：18621327282
"Standard Group
俄羅斯標(biāo)準(zhǔn)集團(tuán)"
杭州EAEU
哈薩克斯坦醫(yī)療器械注冊認(rèn)證，哈薩克斯坦共和國藥品注冊和醫(yī)療器械注冊
哈薩克斯坦醫(yī)療器械注冊認(rèn)證，哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備必須進(jìn)行國家注冊，The list of drugs, IMN and MT subject to state registration
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哈薩克斯坦醫(yī)療器械注冊認(rèn)證，哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備必須進(jìn)行國家注冊，The list of drugs, IMN and MT subject to state registration
哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備必須進(jìn)行國家注冊
The list of drugs, IMN and MT subject to state registration
根據(jù)哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備注冊的法律要求，根據(jù)哈薩克斯坦共和國法典第71條“關(guān)于人民健康和醫(yī)療保健制度”。
什么哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備注冊機(jī)構(gòu)？
哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備注冊、重新登記和修改，通過“電子政府”門戶網(wǎng)站與哈薩克斯坦共和國統(tǒng)一衛(wèi)生信息系統(tǒng)（SULO）的藥物管理系統(tǒng)進(jìn)行。
State registration and re-registration are subject to manufactured in the Republic of Kazakhstan, as well as imported into its territory drugs, medical devices and medical equipment, including:
藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備哈薩克斯坦共和國注冊產(chǎn)品范圍：
1、drugs under the trade names with the indication of the dosage form, dosage, packaging;
2、original medicine;
3、bulk products of medicines, medical products;
4、new combinations of medicines previously registered in the Republic of Kazakhstan with indication of the dosage form, dosage, packaging;
5、medicinal products, previously registered in the Republic of Kazakhstan, but produced by other manufacturers, in other dosage forms, with new dosage, packaging and packaging, other auxiliary substances and the name;
6、medicinal substances not manufactured under good manufacturing practices;
7、drugs of one registration certificate holder produced in different countries at different production sites;
8、medical devices, including diagnostic reagents, contact lenses for vision correction, care products, medical equipment, taking into account their classification depending on the degree of potential risk of medical use;
9、medical devices and medical equipment, previously registered in the Republic of Kazakhstan, but manufactured by other manufacturers;
10、medical devices and medical equipment, previously registered in the Republic of Kazakhstan, but produced in other modifications, with new packaging, a different composition of component parts or a different name;
11、medical devices and medical equipment manufactured by one manufacturer at production sites located (located) in different countries;
12、consumables for medical devices and medical equipment that are medical products, except those specifically designed by the manufacturer for use with a medical product and medical equipment that can function only with this consumable material;
13、medical devices and medical equipment that are part of a specialized vehicle for the provision of medical care;
14、sets (kits) of medical products;
15、laboratory diagnostic devices;
16、medical devices and medical equipment for the prevention, diagnosis, treatment of diseases, assessment of the physiological state of the body, rehabilitation, medical procedures, medical research;
17、medical devices and medical equipment for replacing and modifying parts of tissues, human organs, restoring or compensating for impaired or lost physiological functions;
18、medical devices to control conception.
What document is issued upon completion of the registration procedure for drugs, medical devices and medical equipment? Form RU
1、The state body with a positive decision on registration, re-registration and making changes to the registration dossier of medical devices and medical equipment provides the applicant and expert organization in electronic form
2、registration certificate valid on the territory of the Republic of Kazakhstan;
3、approved instructions for the medical use of the medicinal product, medical devices in the state and Russian languages;
4、an agreed regulatory document on the quality and safety control of a medicinal product, a medical device with an assigned number;
5、approved mock-ups of packaging, labels, stickers on medicines, medical products.
Period of validity of the Registration Certificate
When state registration is established, the validity of the registration certificate is 5 years for medicines, up to 10 years for medicinal substance, medicinal plant raw materials, 5 years for medical products, 7 years for MT.
Upon expiration of the registration certificate of medicines, medical devices and medical equipment is subject to re-registration.
Is a registration certificate issued in the CU member states valid in Kazakhstan?
On the territory of the Republic of Kazakhstan, only the registration certificate issued by the state body of the Republic of Kazakhstan is valid.
Dates of examination
1、Examination of the medicinal product during state registration and introduction of changes requiring new registration shall be carried out within a period not exceeding two hundred and ten calendar days.
2、Duration of the examination of medical devices and medical equipment, depending on the safety class is 90-160 days.
Safety and quality assessment
The deadline for work to assess the safety and quality of medicines and medical products is 30 days.
微信號(hào) 掃一掃聯(lián)系我 公眾號(hào) 掃一掃 關(guān)注我
The list of drugs, IMN and MT subject to state registration
根據(jù)哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備注冊的法律要求，根據(jù)哈薩克斯坦共和國法典第71條“關(guān)于人民健康和醫(yī)療保健制度”。
什么哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備注冊機(jī)構(gòu)？
哈薩克斯坦共和國藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備注冊、重新登記和修改，通過“電子政府”門戶網(wǎng)站與哈薩克斯坦共和國統(tǒng)一衛(wèi)生信息系統(tǒng)（SULO）的藥物管理系統(tǒng)進(jìn)行。
State registration and re-registration are subject to manufactured in the Republic of Kazakhstan, as well as imported into its territory drugs, medical devices and medical equipment, including:
藥品注冊和醫(yī)療器械和醫(yī)療設(shè)備哈薩克斯坦共和國注冊產(chǎn)品范圍：
1、drugs under the trade names with the indication of the dosage form, dosage, packaging;
2、original medicine;
3、bulk products of medicines, medical products;
4、new combinations of medicines previously registered in the Republic of Kazakhstan with indication of the dosage form, dosage, packaging;
5、medicinal products, previously registered in the Republic of Kazakhstan, but produced by other manufacturers, in other dosage forms, with new dosage, packaging and packaging, other auxiliary substances and the name;
6、medicinal substances not manufactured under good manufacturing practices;
7、drugs of one registration certificate holder produced in different countries at different production sites;
8、medical devices, including diagnostic reagents, contact lenses for vision correction, care products, medical equipment, taking into account their classification depending on the degree of potential risk of medical use;
9、medical devices and medical equipment, previously registered in the Republic of Kazakhstan, but manufactured by other manufacturers;
10、medical devices and medical equipment, previously registered in the Republic of Kazakhstan, but produced in other modifications, with new packaging, a different composition of component parts or a different name;
11、medical devices and medical equipment manufactured by one manufacturer at production sites located (located) in different countries;
12、consumables for medical devices and medical equipment that are medical products, except those specifically designed by the manufacturer for use with a medical product and medical equipment that can function only with this consumable material;
13、medical devices and medical equipment that are part of a specialized vehicle for the provision of medical care;
14、sets (kits) of medical products;
15、laboratory diagnostic devices;
16、medical devices and medical equipment for the prevention, diagnosis, treatment of diseases, assessment of the physiological state of the body, rehabilitation, medical procedures, medical research;
17、medical devices and medical equipment for replacing and modifying parts of tissues, human organs, restoring or compensating for impaired or lost physiological functions;
18、medical devices to control conception.
What document is issued upon completion of the registration procedure for drugs, medical devices and medical equipment? Form RU
1、The state body with a positive decision on registration, re-registration and making changes to the registration dossier of medical devices and medical equipment provides the applicant and expert organization in electronic form
2、registration certificate valid on the territory of the Republic of Kazakhstan;
3、approved instructions for the medical use of the medicinal product, medical devices in the state and Russian languages;
4、an agreed regulatory document on the quality and safety control of a medicinal product, a medical device with an assigned number;
5、approved mock-ups of packaging, labels, stickers on medicines, medical products.
Period of validity of the Registration Certificate
When state registration is established, the validity of the registration certificate is 5 years for medicines, up to 10 years for medicinal substance, medicinal plant raw materials, 5 years for medical products, 7 years for MT.
Upon expiration of the registration certificate of medicines, medical devices and medical equipment is subject to re-registration.
Is a registration certificate issued in the CU member states valid in Kazakhstan?
On the territory of the Republic of Kazakhstan, only the registration certificate issued by the state body of the Republic of Kazakhstan is valid.
Dates of examination
1、Examination of the medicinal product during state registration and introduction of changes requiring new registration shall be carried out within a period not exceeding two hundred and ten calendar days.
2、Duration of the examination of medical devices and medical equipment, depending on the safety class is 90-160 days.
Safety and quality assessment
The deadline for work to assess the safety and quality of medicines and medical products is 30 days.
歐亞聯(lián)盟EAEU、俄羅斯、烏茲別克斯/哈薩克斯坦/白俄羅斯/烏克蘭醫(yī)療器械和藥品注冊咨詢服務(wù)
Eurasian Economic Union Russia Uzbekistan Kazakhstan Belarus Ukraine Medical Device and Drug Registration Consulting Services
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微信/電話：18621327282 QQ：594037022 gost-r@163.com 郵編：210201 海關(guān)編碼查詢 俄羅斯醫(yī)療器械注冊證查詢 俄羅斯醫(yī)療注冊證書查詢
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JSC "Standard Group" 俄羅斯標(biāo)準(zhǔn)集團(tuán) HANGZHOU EAEU