012-Russian Medical Device Registration

Order of Russian Government number 1416

Outline

Manufacturer needs to have registration certificate from Ministry of Health for customs clearance, sales and, of course, use.

Additional requirements after registration process is declaration process – in GOST R system and Custom Union Technical Regulation #020 (CU TR 020/2011 – below)

  1. Definition (Same as Europe)

‘medical device’ means any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment, or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement, or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

  1. Classification

Classification is like Europe that based on the risk level, medical devices are classified to Class I, IIa, IIb, and III.
The difference between European classification rule is that

  • There are no class Is or Im. They are all just IIa.
  • Devices used in cosmetic area are all classified as medical device including but not limited to lasers for skin, implants for wrinkles minimizing and so on,

  1. Procedure
  2. Declaration of Conformity
  3. Issued by certification body appointed by Russian government. (There are lots of different certification bodies in Russia and manufacturer is free to choose who to apply the certification)
  4. Only class I devices are subject to DoC procedure. The procedure looks like below.

B. Registration process

I. All devices other than class I.

II. All process are handled by a single government agency called Roszdravnadzor, which is Ministry of Health of Russia. The procedure looks like below.

  1. Test data generated outside of Russia

All test data required to register a medical device to Russia shall be generated in Russia. No matter ISO 17025 accredited or GLP testing lab, all required tests shall be carried out at a testing lab appointed by Russian government.

  1. Pre- and Clinical Investigation
  2. Pre-Clinical Investigation

trial, part of medical device registration process, in Russia means device testing such In most countries, pre-clinical trial call for animal testing. However, pre-clinical as performance and safety test. There is statute on which tests shall be implemented and the data to be submitted, but it is not possible to prepare them in advance.
You need to submit application and required documents first. Upon completion of review of your application documents by RZN, you will be guided to what and where to carry out the pre-clinical trial.

  1. Clinical Investigation

Clinical trials in the Russian registration process are different from those commonly understood in most countries.
The procedure can be understood as review of clinical data submitted by the manufacturer.
However, it is not uncommon for RZN to request clinical trials in Russia.

  1. Documents

Documents which must be submitted along with application are as below.

  • Power of Attorney
  • Business registration
  • Documents to proof effective of quality management system, such as certificate of ISO 13485.
  • Proof of device approval for other countries such as CE certificate and 510(k) letters.
  • Product description
  • Instructions for use (In Russian)
  • List of all models/types and their pictures


It is strongly recommended that you notarize all documents.