Renewal process (Russia)

Renewal process all manufacturers need to change a draft of registration certificate before 2017 if they have registration certificate without expiry date – according to order of Russian Government 1416 from 27/12/2012. Difference between duplicate and changing process is in required documents and strict rule to provide original of old registration certificate for renewal process.

| What is required from manufacturer?

From manufcaturer side BW team needs to have Power of Attorney and scan copy of old registration certificate.

| What is the term?

Term: 1 month.

| What is the process? 


Registration certificate (new form) will have the same number and the same date as in original.

| What is the differences in form of registration certificates?

Old one (before 2013) VS new one (from 2013 year):

  1. “Medical device” or “medical supply” (description by law in old version) – “medical product” from 2013,
  2. Clasification code according to product type (4n classification rule) – for new form,
  3. Factory site in the first page of registration certificate – for new form.

| Updates: 

Order of RG #160 from 10.02.2017 – renewal time before 2021.