Declaration of conformity GOST R is issued according to Order of Russian Government 982 from 01.12.2009 – on the base on OKP classification rules. GOST R certification process is quite different from registration process. Registration process is based on responsibility of manufacturer of medical device and Ministry of Health work (department- ROSZDRAVNADZOR) and approval device as medical by Government. DoC is based on safety confirmation and for this process registration certificate from Ministry of Health is a must. GOST R is acting only in Russian Federation as a national system.

| List of documents:

1. Registration certificate of ROSZDRAVNADZOR,

2. Test reports for applicable standards,

3. Local company who presents interests of manufacturer on Russian Federation territory (who is in charge of quality).

| Limits

DoC is issued for 3 years and limited by registration certificate action: if manufacturer changes any information in registration certificate (or made changing process), he needs to change DoC. The same situation if ROSZDRAVNADZOR suspends registration certificate for medical device – this device could not be in use even if it has declaration of conformity.

| When DoC GOST R is applicable?

When OKP code for medical device is in list of devices for which declaration process is applied.

| How long does it take to receive DoC?

1-2 weeks depends on time of test reports preparation.

| Who can issue DoC GOST R?

Notified body – accredited in Russian Federation for GOST R certification  with medical devices in scope. Formally Notified Body (ND) doesn’t issue but register declaration of conformity.