The Russian Ministry of Health has introduced a new regulation that clarifies the official requirements for in vitro diagnostic (IVD) & medical device technical file submissions.
Issued in Russian, the new regulation known as Order #11N
(link in Russian) sets out existing but unofficial requirements from Russia’s medical device regulator, Roszdravnadzor.
Up until March 24, 2017, when the new requirements became effective, information on the structure of technical documentation had been available only as recommendations and voluntary standards. Technical files in registration dossiers for medical devices and IVD products must now contain specific mandatory clauses/chapters. Contact us today
to discuss the new requirements and to discover how regulatory intelligence and registration management system LICENSALE.COM®
assists MedTech firms in gaining access to 100+ markets faster and more cost-effectively than ever before.