Order of the Federal Service on Surveillance in Healthcare dated 19.07.2017 No 6478 – started 10.09.2017
“On approval of the Procedure for the implementation of consultations connected with medical device registration conducted by the federal State Budget Institutions “Russian research and testing institute for medical devices (VNIIMT)” of Roszdravnadzor and “Centre of monitoring and clinic-economic expertise (CMICEE) of Roszdravnadzor”
According to the Order, VNIIMT and CMICEE are in charge of organization of consultations conducted in accordance with the approved Procedure.
Consultations are carried out in the following areas:
– Issues connected with the development of medical devices and related documents, the procedure for conducting tests (researches) necessary for a medical device state registration;
– Issues connected with the development of documents and the procedure for conducting tests (researches) necessary to make changes in the registration certificate for a medical device;
– Issues connected with the development of documents and the procedure for conducting tests (researches) necessary to make changes in the documents of the medical device registration dossier;
– Matters of rating the product to medical devices
– Issues connected with medical device classification in accordance with the Nomenclature classification for medical devices, approved by the Order 4n of the Ministry of Health of the Russian Federation dated June 6, 2012.
Consultancy is implemented on the basis of a contract between the applicant and expert agency.
The term of consultation of the applicant mustn’t exceed 20 working days after the conclusion of the contract.