Medical Device Registration (Russia)

Medical device registration (Registration for medical devices in Russia)

Medical and healthcare products are under Government control – Roszdravnadzor (department of Ministry of Health, short name is RZN) controls circulation of medical devices on the territory of Russian Federation. How RZN controls medical device market – you can find by link (market surveillance).

| FAQ about this type of approval (FAQ main page – here)

Why registration certificate is required?

Government controls Healthcare industry and patients’ lives.

When registration certificate is used?

  • For customs clearance – when you import your medical device
  • For sales – hospital and medical organizations couldn’t buy non-registered medical device
  • For usage – hospital and medical organizations couldn’t use unregistered medical device

How should I know that my device is medical device?

Classification rules for medical devices is the main criteria. If your product is included in classification rules by Roszdravnadzor (nomenclature code – part of Order of Russian Government #4n)– your device is medical device without any doubts. If your device complies main definition of medical device written in order #1416 but there is no classification code for this device then this is medical device too and during registration process RZN will appoint classification code for this type of device.

How can I start registration process?

Send us product description for quotation, contact us.

What is required for registration process?

Full technical dossier for product – as the main requirement. It is impossible to provide registration process without technical parameters of device.

| How registration process of medical device looks like?

 find information by link

Required documents: 

  1. Power of attorney (special draft),
  2. Business license for manufacturing company,
  3. ISO 13485 or ISO 9001 (could be also replaced by another documents),
  4. CE certificate (preferable but not a strict requirement),
  5. User manual,
  6. Technical dossier (technical specification, risk management file, clinical evaluation, validation sterilization report and another applicable characteristics for current product).

!!! All documents must be legalized in country of origin.

| Features of state registration process for different types of medical products

Find answer here

| How translation process and legalization are provided? 

Find answer here

| Information about measuring medical devices

Measuring medical devices required special additional testing during registration process. How to know that medical device is measuring medical device – find answer here.

| Information about clinical trials

Is testing which patients required? How to deal with clinical trials – by link

| About license holder

Who is license holder? Explanation for one of the most hot topic – by link

| Medical device regulation – additional information about approval

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