One Year to Replace “Old” Registration Certificates.

Why?

According to clause #2 of Russian Medical Device Registration Rules (Resolution 1416):

Medical device and medical equipment registration certificates with an unlimited validity period, issued before the effective date of this Resolution, shall be valid until and be replaced on January 1, 2017, with registration certificates in the format approved by the Federal Service for Healthcare Supervision (Roszdravnadzor).

A registration certificate shall be replaced without the repeated state registration of medical devices, on the basis of the application submitted by the applicant to the Federal Service for Healthcare Supervision and containing the information envisaged in the Rules provided for by this Resolution.

Does my certificate need replacement?

How does registration certificate with an unlimited validity period look like (need replacement by 01.01.2017):

old registration1

How does new format registration certificate look like:

new registration1

What is the process?

  1. Sign the Power of Attorney/Autorization letter in the name of Russian Autorized Representative (legalization with apostile is required).
  2. Complete the application form;
  3. Submit the file to Roszdravnadzor (1+2+a scan copy of “old” certificate);
  4. Review time 2-4 weeks (for Q4 2015);
  5. Return paper copy of “old” certificate and get the new one.

8 thoughts on “One Year to Replace “Old” Registration Certificates.

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