EMC CENTRE provides services on medical products registration according to requirements of Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor).
Medical Certificate shows that medical product has passed through registration process on Russian Federation territory and has been included into the State Register. If product, being instrument or equipment, is intended to use on Russian Federation territory, it is compulsory to go through the registration process.
The following products are subject to registration:
- Medical software;
- Medical equipment;
- Medical products;
- Instruments and expendables.
There is a medical products ranking according to potential risk:
- Class 1 - low risk products (medical scales, microscopes, audiologic screening devices etc.);
- Class 2 a - medium risk products (laboratory equipment, audiometers, spirometers etc.);
- Class 2b - increased risk products (defibrillators, cardio analyzers etc.);
- Class 3 - high risk products (endoprosthesises, implants, lithotripters etc.).
In 2005-2006 (before Roszdravnadzor Administrative procedure came into effect) an old style Medical Certificate was issued for 10 years of validity; start date and date of expiry were indicated.
In the end of 2006 a new style Medical Certificate was accepted according to requirements of Roszdravnadzor Administrative procedure. New style Medical Certificate has no limitations on period of validity under following conditions:
- Medical product data remains unchanged;
- Identifying information of registration maker remains unchanged.
Extensive documentation has to be accomplished to receive Medical Certificate:
- Comparison table of product specification and its analog (in the absence thereof clinical tests and documentation expertise are assigned, leading to delays and large cost increasing);
- Documents to justify production conformity to international requirements.
- Acceptance trials reports;
- Toxicity tests protocol (in the absence thereof request to carry out such tests is made, proper samples have to be provided).
It is compulsory to get Certificate of Metrology for equipment with measuring tools.
In this context, applying to EMC CENTRE for certification of medical products allows to get a competent evaluation of all paperwork needed. That saves time and money for our clients.
According to Clause 2 of Russian Federation Government Decree No.1416 dated 27.12.2012 “State registration rules for medical products" Medical Certificates issued before 1st January 2013 that didn't show expiration date (so called "lifetime" certificates) have to be reissued.