Medical Devices
Medical device manufacturers in Australia seeking to enter the Russia market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Federal Service for Surveillance in Healthcare (Roszdravnadzor) oversees medical device regulation in Russia, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.
Taylored Consultancy provides complete medical device regulatory support for Australia companies expanding to Russia. Our services include device classification, technical file preparation, clinical evaluation, UK Responsible Person (UKRP) or EC Representative (EC-REP) services, and ongoing post-market surveillance to ensure full compliance throughout your product lifecycle.
Comprehensive risk classification under Russia medical device regulations, conformity assessment pathway determination, and regulatory strategy development.
Complete registration process with Federal Service for Surveillance in Healthcare (Roszdravnadzor), including dossier preparation, technical documentation, submission management, and authority liaison for approval.
We act as your authorized representative in Russia, handling regulatory communications, maintaining compliance documentation, and managing authority interactions.
Complete technical file preparation including device description, design verification, risk management, clinical evaluation, and manufacturing documentation for Russia.
ISO 13485 quality management system verification, manufacturing evidence compilation, GMP compliance documentation, and quality assurance systems for Russia approval.
Conformity certificates, import licenses, market authorization applications, and ongoing post-market surveillance requirements for successful Russia market entry.
