| News

1 — by Tag #news in tag-cloud and by date in our website and official NewsLetter — Newsletter BWTeam (if you want to subscribe — please contact us).

2 — subscription by email — see menu in the right sidebar of main page.

 

| Links

| Official documents:

• RUSSIAN FEDERATION GOVERNMENT DECREE dated 5 February 2015 No. 102 (about Government purchases in Russia — see here)
• Order of Ministry of Health of the Russian Federation #89n dated August 15, 2012 (about measuring medical devices — list of devices here)
• Order of Russian Government 521n from 08.08.2016 (updates in changing process, duplicate and main registration)
• Order of Russian Government #160 from 10.02.2017 (updates in renewal process, classification code and expert center consulting)
• Decision of the Board of the Eurasian Economic Commission dated 15.11.2016 No.145 “On Amendments to Some Decisions of the Commission of the Customs Union and Eurasian Economic Commission” (starting from 1 January 2017)
• Subsidies for Russian Manufacturers (Decree of the Government of the Russian Federation of 1 October 2015 No.1046, Decree of the Government of the Russian Federation of 1 October 2015 No.1048)
• Order of the Federal Service on Surveillance in Healthcare dated 19.07.2017 No 6478 (started 10.09.2017 – about consultancy in expert centers)
• Order of the Ministry of Healthcare of Russia dated Jan 09, 2014 N 2n “On approval of the procedure for the assessment of the compliance of medical devices in the form of technical trials, toxicological studies and clinical trials for medical device state registration purposes” (Registered in the Ministry of Justice of Russia on April 03, 2014. No. 31813) — main law about trials for medical device registration process

| Links — Resources about medical devices — Regulators

• Russia — Roszdravnadzor —  http://www.roszdravnadzor.ru/ (main page)

Registered medical devices database (RZN — official) — find it here (unfortunately only in Russian).

Entering number — http://www.roszdravnadzor.ru/services/cab_mi (you should enter ID number of dossier and first date of submission)

• Kazakhstan — http://www.dari.kz/category/search_prep
• Ukraine — http://www.moz.gov.ua/ua/portal/
• Belarus — http://minzdrav.gov.by/ 

| Links — Resources about cosmetics and beauty product

• Custom Union Regulation (Russia + Kazakhstan + Belarus + Kyrgyzstan + Armenia) — http://www.eaeunion.org/

| Links — Resources about biologics and drugs

• Russia —http://www.roszdravnadzor.ru/drugs 

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©Beawire — July 2016, last updates Aug 2018.