On 10 September 2017, the order #6478 (link in Russian) came into force.
This order introduces pre-submission consultations from Russian regulatory expert centers involved in the registration process to medical device manufacturers for requesting feedback prior to start registration, local testing or submitting a medical device application to Roszdravnadzor (Russian medical device regulator) as far as discussing specific aspects of the Russian regulatory process and requirements (e.g. medical device classifications and designation of a product to medical device regulations).
Until now, Russian law did not allow such forms of consultancy, and direct communication between manufacturers and authorities on any specific question was formally prohibited.
Consultations will be paid for medical device manufacturers but not mandatory for obtaining approval.
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