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).
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.