Medical device regulation

| FAQ:

  1. How to do documents legalization?
  2. About medical device registration in Russia – main information.
  3. Which devices are measuring medical devices and why this is important?
  4. About medical device registration with drug (Sept 2017 update)

| Regulation for medical devices (legal documents and Government laws) – national state registration process inside Russian Federation:

    • Current version of Order of Russian Government 1416 from 27.12.2012 (main law about registration process for medical devices in Russian Federation);
    • Amendments and changing for Order of Russian Government 1416 from 27.12.2012:
      • Order of Russian Government #160 from 10.02.2017 “About changes in Order of Russian Government #1416 from 27.12.2012” – prolongation of registration certificates without expiry date (“old forms of registration certificates”), consulting services from expert centers side – by link;
      • Order of Russian Government 521n from 08.08.2016 (changes in Order of Russian Government 1416) – by link;
      • Order of Russian Government 633 from 31.05.2018 ((changes in Order of Russian Government 1416) – review by link;
    • State registration process:
      • Main law for testing process (pre-clinical and clinical trials) – Order of Russian Government 2n – by link  ;
      • Order of Ministry of Health of the Russian Federation #89n dated August 15, 2012 – measuring medical devicesby link;
      • Order of Russian Government 11n – requirements for technical file and IFU (started from 2017);
      • Order of Russian Government 4n – classification rules for medical devices in Russia;
      • Order of the Federal Service on Surveillance in Healthcare dated 19.07.2017 No 6478 (started 10.09.2017 – about consultancy in expert centers) – how expect centers should provide consulting services;
      • About OKP to OKPD2 changes in registration certificate form – official letter from RZN to customs ;
    • Safety monitoring:
    •  Sales and support for medical devices:
    • Import/export license for human organs and tissuesHS EAEU codes here;
    • Resolution of the Government of the Russian Federation as of 18/12/2016 No. 1327;
    • Technical regulation 2018 – articles about main medical device regulation topics from BW team – by link;

| EAEU regulation for medical devices:

  • EAEU regulation (EAC MED) – Recommendation #17 (list of applicable standards) – https://beawire.com/2017/09/12/eac-mark-list-of-applicable-standards/ ;
  • 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 of January 2017) – import/export of human organs and tissues (with HS EAEU codes) – by link;

| Another topics:

  • About VAT (tax free during sales) – VAT memorandum
    • Order of Russian Government #1042 from 30.09.2015 – list of products with 0% VAT;
    • Order of Russian Government #50 from 23.01.2018 (about changes in Order of Russian Government #688 from 15.09.2008) – current version of Order of Russian Government #688 from 15.09.2008 with amendments -list of products with 10% VAT for products;
  • Import/export license for human organs and tissuesHS EAEU codes here;
  • About localization of medical device manufacturing – future of manufacturing in Russia;
  • Resolution of the Government of the Russian Federation as of 18/12/2016 No. 1327;
  • Technical regulation 2018 – articles about main medical device regulation topics from BW team – by link;

 

| Biomedical cell products: