office 311, 21 Uborevicha str.
Vladivostok, Russia

China, Shenzhen, Yizhang Bldg 1-2709

consultations
9:00-21:00

+7 (423) 276-53-83

Russian, English, Chinese

+86 186 58878488

Clients

  • China is building, LLC Vladivostok
  • World of Packing, LLC Khabarovsk
  • Magadan fish, LLC Magadan
  • Daltehenergo, Co Vladivostok
  • Irkutsk Bakery plant, LLC Irkutsk
  • Benetton, LLC Khabarovsk
  • MARTIN, LLC Vladivostok
  • Pharmacy, LLC Vladivostok
  • AQUA, LLC Yakutsk
  • AGATE, Co Krasnoyarsk
  • Alexandrine bread, LLC Magadan
  • CROC DV, LLC Khabarovsk
  • Nereid, LLC Vladivostok
  • Komteks-A, LLC Moscow
  • Pacific Oil, LLC Vladivostok
  • ArktikServis, LLC Petropavlovsk

Issued Certificates

Сертификат ИСО 9001 Новосибирск. Бамтоннель. tezis 5200 evro4 cbkts (1) ssagat

Registration Certificate of the Federal Service for the Supervision of Public Health and Social Development

The cost of the certification depends on the type and testing of the product, ranging from $15,000.
The processing time: 8 to 12 months.

 

Registration Certificate of the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor) (of the Ministry of Health of the Russian Federation)

Registration Certificate of the Federal Service for the Supervision of Public Health and Social DevelopmentAll medical devices intended for medical use in the Russian Federation are subject to registration and subsequently should obtain the Registration Certificate. From the 1st of January 2013 the registration of medical devices is based on the Decree of the Government of the Russian Federation of the 27th of December 2012 № 1416.

Certificate Prim offers registration and certification services for medical devices and medical equipment, pharmaceutical raw materials and medicinal drugs.

Our specialists are ready to assist you in gathering all the necessary documents, review the documentation, as well as make the necessary amendments, if required for the issue of the Registration Certificate.

Registration includes document preparation, testing, expert quality, efficiency and safety reports for medical devices. Also, the class of the potential risk associated with the product is determined.

Stages of the registration process:
• request to provide product samples and documents
• initial testing
• preparation of the initial set of documents for registration
• submission of the documents to the Ministry of Health of the Russian Federation and receipt of comments
• referral for clinical testing and its implementation
• examination of the full set of documents
• issue of the Permit

Request
 
Information

Reviews

Благодраственное от Исаенко
sumitomo

Contacts

office 311, 21 Uborevicha str.
Vladivostok, Russia

8 (804) 333-00-938 (423) 276-53-83

International Centre for certification in Vladivostok, Product certification, declaration of conformity, certificate of conformity Euro 5 and Euro 5 for cars from Arab Emirates (UAE), the security certificate TC certificate ISO 9001, ISO 9001-2011, HACCP certificate, GOST R ISO 22000- 2007 ISA certificate, MSA