
Obtaining a declaration of conformity to GOST R for medical devices
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:
- Registration certificate of ROSZDRAVNADZOR,
- Test reports for applicable standards,
- 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.
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